IEC 62366:2007+AMD1:2014 CSV
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Medical devices - Application of usability engineering to medical devices
Amended by
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Superseded date
09-12-2022
Language(s)
English - French
Published date
01-28-2014
Publisher
FOREWORD
INTRODUCTION
INTRODUCTION TO THE AMENDMENT
1 Scope
2 Normative references
3 Terms and definitions
4 Principles
5 USABILITY ENGINEERING PROCESS
6 ACCOMPANYING DOCUMENT
7 Training and materials for training
Annex A (informative) - General guidance and rationale
Annex B (informative) - Categories of USER action
Annex C (informative) - Examples of USE ERRORS, ABNORMAL USE and
possible causes
Annex D (informative) - Guidance on the USABILITY ENGINEERING
PROCESS
ANNEX E (informative) - Questions that can be used to identify
MEDICAL DEVICE characteristics associated with USABILITY
that could impact on SAFETY
ANNEX F (informative) - Examples of possible USABILITY related
HAZARDOUS SITUATIONS
Annex G (informative) - USABILITY goals: Illustrative example
for a home parenteral infusion pump
ANNEX H (informative) - Sample USABILITY SPECIFICATION and its
inputs
Annex I (informative) - Recommended reading list
Annex J (informative) - Reference to the essential principles
Annex K (normative) - Evaluation of a USER INTERFACE OF
UNKNOWN PROVENANCE (UOUP)
Bibliography
Index of defined terms
IEC 62366:2007+A1:2014 Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this International Standard has been complied with and the acceptance criteria documented in the usability validation plan have been met, then the residual risks, as defined in ISO 14971, associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary. This International Standard does not apply to clinical decision-making relating to the use of a medical device. This consolidated version consists of the first edition (2007) and its amendment 1 (2014). Therefore, no need to order amendment in addition to this publication.
| Committee |
TC 62/SC 62A
|
| DevelopmentNote |
Stability Date: 2014. (01/2014) Superseded by IEC 62366-1, but remains current and will be withdrawn on publication of IEC 62366-2. (07/2015)
|
| DocumentType |
Standard
|
| Pages |
436
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NF EN 62366 : 2008 AMD 1 2015 | Identical |
| AAMI IEC 62366 : 2015 | Identical |
| VDE 0750-241 : 2016 | Identical |
| EN 62366 : 2008 AMD 1 2015 | Identical |
| PN EN 62366 : 2008 AMD 1 2015 | Identical |
| BS EN 62366 : 2008 | Identical |
| GOST R IEC 62366 : 2013 | Identical |
| DIN EN 62366 : 2016 | Identical |
| I.S. EN 62366:2009 | Identical |
| UNE-EN 62366:2009 | Identical |
| NEN EN IEC 62366 : 2008 AMD 1 2015 | Identical |
| DIN EN ISO 10524-4:2008-09 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS |
| CSA C22.2 No. 60601-2-66 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS |
| I.S. EN ISO 80369-1:2010 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| NF EN ISO 80601-2-69 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT |
| ISO 14708-1:2014 | Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
| CEI EN 60601-1-11 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| CSA ISO 15197 : 2015 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
| CSA ISO 5361 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS |
| 14/30270462 DC : 0 | BS EN ISO 5840-1 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS |
| ANSI/AAMI/ISO 80369-3:2016 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS |
| NF EN ISO 7494-1 : 2011 | DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
| BS EN ISO 5840-2:2015 | Cardiovascular implants. Cardiac valve prostheses Surgically implanted heart valve substitutes |
| 14/30298693 DC : 0 | BS ISO 18250-8 - CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS FOR HEALTHCARE APPLICATIONS - PART 8: CITRATE-BASED ANTICOAGULANT SOLUTION FOR APHERESIS APPLICATIONS |
| UNI EN ISO 23908 : 2013 | SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS PROTECTION FEATURES FOR SINGLE-USE HYPODERMIC NEEDLES, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING |
| PD IEC/TR 62366-2:2016 | Medical devices Guidance on the application of usability engineering to medical devices |
| AAMI ISO 80369-1 : 2010 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| PD ISO/TS 17518:2015 | Medical laboratories. Reagents for staining biological material. Guidance for users |
| UNI EN ISO 18113-5 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF- TESTING |
| 09/30203808 DC : 0 | BS EN ISO 80601-2-12 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
| 17/30303094 DC : 0 | BS EN ISO 10524-3 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
| 13/30268585 DC : 0 | BS EN ISO 10079-1 - MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT |
| 13/30242951 DC : 0 | BS ISO 16571 - MEDICAL GAS SYSTEMS - SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES |
| DIN EN ISO 18113-3:2013-01 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE (ISO 18113-3:2009) |
| I.S. EN 60601-1-10:2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
| 13/30245306 DC : 0 | BS EN ISO 9680 - DENTISTRY - OPERATING LIGHTS |
| DIN EN ISO 80601-2-69 E : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT (ISO 80601-2-69:2014) |
| 10/30205392 DC : 0 | BS ISO 7494-1 - DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
| 09/30191860 DC : 0 | BS EN 60601-1-6 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD - USABILITY |
| I.S. EN ISO 23908:2013 | SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS PROTECTION FEATURES FOR SINGLE-USE HYPODERMIC NEEDLES, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING (ISO 23908:2011) |
| UNE-EN ISO 18113-3:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009) |
| BS EN 62083:2009 | Medical electrical equipment. Requirements for the safety of radiotherapy treatment planning systems |
| BS EN ISO 18113-3:2011 | In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for professional use |
| CSA ISO 14971 : 2007 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| BIS IS/ISO 15197 : 2013 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEM FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
| DIN EN ISO 5840-3:2013-06 | Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
| UNE-EN ISO 80601-2-69:2015 | Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) |
| CAN/CSA-C22.2 NO. 80601-2-72:17 | Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (Adopted ISO 80601-2-72:2015, first edition, 2015-09-01, with Canadian deviations) |
| ONORM EN ISO 5840-3 : 2013 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013) |
| ANSI/AAMI/ISO 5840-3:2013 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES |
| AAMI HE75 : 2009(R2013) | HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
| AAMI ISO 5361 : 2012 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS |
| ISO 16571:2014 | Systems for evacuation of plume generated by medical devices |
| I.S. EN ISO 10524-4:2008 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOWPRESSURE REGULATORS |
| I.S. EN 60601-2-66:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART-2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS |
| BS EN ISO 80601-2-12:2011 | Medical electrical equipment Particular requirements for basic safety and essential performance of critical care ventilators |
| BS EN 60601-1-6 : 2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY |
| ISO/TS 17137:2014 | Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants |
| UNI CEI EN ISO 80369-1 : 2011 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| UNE-EN ISO 18113-5:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009) |
| CSA C22.2 No. 60601.2.1 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-1: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTRON ACCELERATORS IN THE RANGE 1 MEV TO 50 MEV |
| I.S. EN 1865-2:2010 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
| PD ISO/TS 17137:2014 | Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants |
| ASTM F 2761 : 2009 : R2013 | Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| DIN EN ISO 9680 E : 2015 | DENTISTRY - OPERATING LIGHTS (ISO 9680:2014) |
| BS EN 1782 : 1998 | TRACHEAL TUBES AND CONNECTORS |
| ISO 10524-4:2008 | Pressure regulators for use with medical gases — Part 4: Low-pressure regulators |
| BS EN 13718-1:2014 | Medical vehicles and their equipment. Air ambulances Requirements for medical devices used in air ambulances |
| ISO 7494-2:2015 | Dentistry — Stationary dental units — Part 2: Air, water, suction and wastewater systems |
| UNE-EN ISO 11608-1:2015 | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014) |
| ISO/IEEE 11073-00103:2015 | Health informatics Personal health device communication Part 00103: Overview |
| ISO 80369-3:2016 | Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications |
| BS EN 12342 : 1998 | BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS |
| I.S. EN ISO 11608-1:2015 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS (ISO 11608-1:2014) |
| DIN EN 12342:1998-09 | BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS |
| DIN EN 12342:2010-01 | BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS |
| EN ISO 15002:2008 | Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008) |
| EN 60601-2-16:2015 | Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
| EN ISO 9680:2014 | Dentistry - Operating lights (ISO 9680:2014) |
| EN 13544-1:2007+A1:2009 | Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
| ONORM EN ISO 11608-5 : 2012 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS (ISO 11608-5:2012) |
| BS EN ISO 15002:2008 | Flow-metering devices for connection to terminal units of medical gas pipeline systems |
| CAN/CSA-ISO 16571:16 | SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES |
| UNE-EN ISO 80369-1:2011 | Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010) |
| 09/30173644 DC : 0 | BS EN ISO 80369-1 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| I.S. EN 285:2015 | STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| BS EN ISO 5359 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES |
| BS ISO/IEEE 11073-00103 : 2015 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW |
| UNE-EN ISO 11608-5:2013 | Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012) |
| 15/30280196 DC : 0 | BS ISO/IEC 25022 - SYSTEMS AND SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE QUALITY REQUIREMENTS AND EVALUATION (SQUARE) - MEASUREMENT OF QUALITY IN USE |
| NF EN ISO 80369-1 : 2011 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| 08/30154605 DC : DRAFT APR 2008 | BS ISO 15223-2 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 2: SYMBOL DEVELOPMENT, SELECTION AND VALIDATION |
| UNI EN ISO 5367 : 2015 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
| 16/30216785 DC : 0 | BS EN 62667 - MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS |
| DIN EN ISO 11608-5:2013-01 | Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012) |
| I.S. EN 1865-3:2012 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
| 11/30206856 DC : 0 | BS EN 60601-1-8:2007/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS |
| DIN EN ISO 80601-2-72:2016-04 | Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015) |
| AAMI IEC 80601-2-30 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
| 06/30146526 DC : 0 | BS ISO 18113-5 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING |
| 14/30315340 DC : 0 | BS EN 60601-2-66 ED.2 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS |
| I.S. EN ISO 5840-3:2013 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013) |
| 14/30290166 DC : 0 | BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| BS EN ISO 80369-1:2010 | Small bore connectors for liquids and gases in healthcare applications General requirements |
| UNE-EN 60601-2-66:2016 | Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
| 14/30281560 DC : 0 | BS EN ISO 5840-2 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES |
| PD ISO/TS 19218-2:2012 | Medical devices. Hierarchical coding structure for adverse events Evaluation codes |
| DIN EN ISO 15002:2008-11 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
| UNI EN ISO 80601-2-12 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
| 15/30280904 DC : 0 | BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT |
| CAN/CSA-Z15002:12 (R2017) | Flow-metering devices for connection to terminal units of medical gas pipeline systems (Adopted ISO 15002:2008, second edition, 2008-07-01, with Canadian deviations) |
| BS EN 60601-2-66:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
| 12/30271196 DC : 0 | BS EN 60601-1-10:2007/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
| 14/30294895 DC : 0 | BS EN ISO 8537 - STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN |
| CSA Z1500:2012 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
| CSA C22.2 No. 60601.1.8 : 2008 : R2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS |
| BS EN ISO 80369-3:2016 | Small-bore connectors for liquids and gases in healthcare applications Connectors for enteral applications |
| NF EN 60601-1-11 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| PD IEC/TR 60601-4-3:2015 | Medical electrical equipment Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements |
| UNI EN ISO 5840-3 : 2013 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES |
| UNE-EN ISO 10079-1:2016 | Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015) |
| UNE-EN ISO 20072:2013 | Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009) |
| I.S. EN 60601-1-6:2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY |
| AAMI ISO 5367 : 2015 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
| BS EN 60601-1-8 : 2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006) |
| CSA ISO 10079-3:14 (R2019) | Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (Adopted ISO 10079-3:2014, third edition, 2014-05-01) |
| UNE-EN ISO 7494-1:2012 | Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011) |
| AAMI IEC 60601-2-16 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEMODIALYSIS, HEMODIAFILTRATION AND HEMOFILTRATION EQUIPMENT |
| AAMI ISO TIR 17137 : 2014 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOVASCULAR ABSORBABLE IMPLANTS |
| I.S. EN ISO 80369-3:2016 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS (ISO/IEC/DIS 80369-3:2014) |
| I.S. EN ISO 5840-1:2015 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015) |
| EN 60601-1-8:2007/A11:2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012) |
| CEI UNI EN ISO 80369-1 : 2011 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| ISO 7494-1:2011 | Dentistry Dental units Part 1: General requirements and test methods |
| CSA C22.2 No. 60601.1.8 : 2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS |
| CAN/CSA-ISO 10079-1:16 | Medical suction equipment - Part 1: Electrically powered suction equipment (Adopted ISO 10079-1:2015, third edition, 2015-11-01) |
| CSA C22.2 No. 60601.2.49 : 2011 : R2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT |
| CSA C22.2 No. 80601-2-69 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT |
| CSA ISO 10079-2 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT |
| I.S. EN 60601-2-16:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT |
| UNE-EN ISO 14457:2013 | Dentistry - Handpieces and motors (ISO 14457:2012) |
| BS EN ISO 5367:2014 | Anaesthetic and respiratory equipment. Breathing sets and connectors |
| UNE-EN ISO 5367:2015 | Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
| UNE-EN ISO 18113-1:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| AAMI ISO 15223-2 : 2010 | MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELING AND INFORMATION TO BE SUPPLIED - PART 2: SYMBOL DEVELOPMENT, SELECTION AND VALIDATION |
| CSA C22.2 No. 80601-2-12 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
| CSA C22.2 No. 60601-1-10 : 2009 : R2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| CEI UNI EN ISO 14971 : 2013 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| IEC TR 61258:2008 | Guidelines for the development and use of medical electrical equipment educational materials |
| I.S. EN 62083:2009 | MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS |
| ISO 5367:2014 | Anaesthetic and respiratory equipment — Breathing sets and connectors |
| I.S. EN ISO 14971:2012 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01) |
| DIN EN ISO 6875:2011-10 | DENTISTRY - PATIENT CHAIR |
| DIN EN 1782:2009-12 | TRACHEAL TUBES AND CONNECTORS |
| DIN EN ISO 7494-2:2015-08 | Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015) |
| DIN EN ISO 14971:2013-04 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
| DIN EN ISO 5840-2 E : 2016 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015) |
| BS EN ISO 7494-2:2015 | Dentistry. Dental units Air, water, suction and wastewater systems |
| BS EN 45502-1:2015 | Implants for surgery. Active implantable medical devices General requirements for safety, marking and for information to be provided by the manufacturer |
| BS EN ISO 10079-2:2014 | Medical suction equipment Manually powered suction equipment |
| 14/30311240 DC : 0 | BS EN 61010-1 ED 3 AMD 1 - SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
| DIN EN ISO 9680:2015-02 | Dentistry - Operating lights (ISO 9680:2014) |
| I.S. EN ISO 15197:2015 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013) |
| I.S. EN ISO 6875:2011 | DENTISTRY - PATIENT CHAIR |
| EN ISO 5840-2:2015 | Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015) |
| I.S. EN ISO 10079-2:2014 | MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT (ISO 10079-2:2014) |
| I.S. EN ISO 9680:2014 | DENTISTRY - OPERATING LIGHTS (ISO 9680:2014) |
| EN ISO 5840-1:2015 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
| UNI EN 13718-1 : 2014 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
| I.S. EN ISO 7494-2:2015 | DENTISTRY - DENTAL UNITS - PART 2: AIR, WATER, SUCTION AND WASTEWATER SYSTEMS (ISO 7494-2:2015) |
| EN ISO 5840-3:2013 | Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
| I.S. EN 45502-1:2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| I.S. EN ISO 10079-3:2014 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE (ISO 10079-3:2014) |
| VDI 5702 Blatt 1:2017-04 | Medical device software - Medical SPICE Process assessment model |
| UNE-EN ISO 5840-2:2016 | Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015) |
| ISO 80601-2-61:2017 | Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
| I.S. EN ISO 11073-00103:2017 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015) |
| 11/30215841 DC : 0 | BS EN ISO 14457 - DENTISTRY - HAND PIECES AND MOTORS |
| 14/30296572 DC : 0 | BS EN 60601-1-11 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| DIN EN 1865-2:2015-05 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
| BS ISO 15223-2:2010 | Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied Symbol development, selection and validation |
| ANSI/AAMI/IEC TIR62348:2012 | ASSESSMENT OF THE IMPACT OF THE MOST SIGNIFICANT CHANGES IN AMENDMENT 1 TO IEC 60601-1:2005 AND MAPPING OF THE CLAUSES OF IEC 60601-1:2005 TO THE PREVIOUS EDITION |
| DIN EN ISO 80601-2-72 E : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015) |
| ISO/TS 17518:2015 | Medical laboratories — Reagents for staining biological material — Guidance for users |
| UNI EN ISO 80601-2-69 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT |
| 13/30255929 DC : 0 | BS EN ISO 7396-1 - MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM |
| BS ISO 27427:2013 | Anaesthetic and respiratory equipment. Nebulizing systems and components |
| BS EN 60601-2-68:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
| BS EN ISO 11608-5:2012 | Needle-based injection systems for medical use. Requirements and test methods Automated functions |
| I.S. EN ISO 18113-1:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
| AAMI ISO TIR 19218-2 : 2012 | MEDICAL DEVICES - HIERARCHICAL CODING STRUCTURE FOR ADVERSE EVENTS - PART 2: EVALUATION CODES |
| 14/30281833 DC : 0 | BS EN ISO 17509 - DENTISTRY - TORQUE TRANSMITTER FOR HANDPIECES USED FOR IMPLANTATION |
| 12/30246621 DC : 0 | BS EN 60601-2-68 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY BASED IMAGE GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT |
| 10/30208977 DC : 0 | BS EN ISO 11608-1 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS |
| BS EN ISO 5840-1:2015 | Cardiovascular implants. Cardiac valve prostheses General requirements |
| UNI EN ISO 20072 : 2013 | AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS |
| BS EN ISO 5840-3:2013 | Cardiovascular implants. Cardiac valve prostheses Heart valve substitutes implanted by transcatheter techniques |
| CSA Z10524-4 : 2012 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS |
| UNE-EN 60601-1-6:2010 | Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| BS EN 60601-1-10 : 2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
| UNE-EN ISO 5840-1:2016 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
| CAN/CSA-C22.2 NO. 80601-2-67:17 | Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen conserving equipment (Adopted ISO 80601-2-67:2014, first edition, 2014-06-01, with Canadian deviations) |
| DIN EN ISO 5840-2:2016-05 | Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015) |
| UNI EN ISO 11608-5 : 2013 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS |
| I.S. EN ISO 5361:2016 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS (ISO/DIS 5361:2014) |
| IEC TR 80002-1:2009 | Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software |
| DIN EN ISO 5840-1:2015-12 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
| BS EN 60601-2-49:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
| BS EN 1865-2 : 2010 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
| PREN ISO 80369-1 : DRAFT 2009 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| AAMI HE75 : 2009 | HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
| I.S. EN ISO 5840-2:2015 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015) |
| I.S. EN 60601-1-8:2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS |
| ISO 10079-1:2015 | Medical suction equipment Part 1: Electrically powered suction equipment |
| I.S. EN 80601-2-30:2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
| AAMI ISO 5840-1 : 2016 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS |
| AAMI ISO 14708-5 : 2010 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES |
| EN 60601-2-1:2015 | Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV |
| EN 60601-1-10:2008/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS (IEC 60601-1-10:2007) |
| UNI EN ISO 5361 : 2013 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS |
| ISO/IEC 25022:2016 | Systems and software engineering Systems and software quality requirements and evaluation (SQuaRE) Measurement of quality in use |
| ISO 11040-8:2016 | Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes |
| CSA ISO 10079-3 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE |
| ISO/TS 19218-2:2012 | Medical devices Hierarchical coding structure for adverse events Part 2: Evaluation codes |
| CSA C22.2 No. 60601-2-68 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT |
| CSA C22.2 No. 60601.2.1 : 2011 : INC : AMD 1 : 2015 : R2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-1: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTRON ACCELERATORS IN THE RANGE 1 MEV TO 50 MEV |
| CSA C22.2 No. 60601-1-10:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
| EN ISO 80369-1:2010 | Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010) |
| BS EN ISO 14971:2012 | Medical devices. Application of risk management to medical devices |
| ISO 15002:2008 | Flow-metering devices for connection to terminal units of medical gas pipeline systems |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| DIN EN 13544-1:2009-12 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| DIN EN 285:2016-05 | Sterilization - Steam sterilizers - Large sterilizers |
| DIN EN 13718-1:2014-12 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
| DIN EN ISO 10079-3:2014-09 | Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014) |
| DIN EN ISO 11608-1:2015-04 | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014) |
| BS EN 60601-2-16:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
| ISO 15197:2013 | In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| ISO 80601-2-69:2014 | Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment |
| IEC 60601-2-66:2015 | Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
| CSA Z8000 : 2011 : R2016 | CANADIAN HEALTH CARE FACILITIES |
| CSA Z8000 : 2011 | CANADIAN HEALTH CARE FACILITIES |
| CSA Z8000 : 2011 : INC : UPD 1 : 2013 | CANADIAN HEALTH CARE FACILITIES |
| EN ISO 80601-2-69:2014 | Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) |
| I.S. EN 13544-1:2007 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| UNE-EN 1782:1998 | TRACHEAL TUBES AND CONNECTORS. |
| CSA C22.2 No. 80601-2-12 : 2012(R2017) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
| EN ISO 7494-2:2015 | Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015) |
| EN 1782:1998+A1:2009 | Tracheal tubes and connectors |
| UNI EN ISO 6875 : 2011 | DENTISTRY - PATIENT CHAIR |
| EN 45502-1:2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| UNI EN ISO 10079-3 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE |
| ONORM EN ISO 10079-2 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT (ISO 10079-2:2014) |
| UNI EN ISO 10079-2 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT |
| UNI EN 13544-1 : 2009 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| UNI EN 12342 : 2009 | BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS |
| ONORM EN ISO 10079-3 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE (ISO 10079-3:2014) |
| UNI EN 1782 : 2009 | TRACHEAL TUBES AND CONNECTORS |
| UNE-EN ISO 5361:2017 | Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016) |
| BS ISO 16571:2014 | Systems for evacuation of plume generated by medical devices |
| ANSI/AAMI HA60601-1-11:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| CAN/CSA-C22.2 NO. 60601-1-8:08 (R2018) | Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Adopted IEC 60601-1-8:2006, second edition, 2006-10) | Appareils électromédicaux - Partie 1-8: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences générales, essais et guide pour les systèmes d\'alarme des appareils et des systèmes électromédicaux (norme IEC 60601-1-8:2006 adoptée, deuxième édition, 2006-10) |
| DIN EN ISO 20072:2013-10 | AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009) |
| NF EN 1865-2 : 2011 + A1 2016 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHERS |
| 14/30277509 DC : 0 | BS ISO 18250-3 - CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS - PART 2: ENTERNAL APPLICATIONS |
| BS EN ISO 20072:2013 | Aerosol drug delivery device design verification. Requirements and test methods |
| EN ISO 5359:2014/A1:2017 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014/AMD 1:2017) |
| 08/30192448 DC : DRAFT DEC 2008 | BS ISO 14708-5 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES |
| BS EN ISO 80601-2-72:2015 | Medical electrical equipment Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
| AAMI/IEC TIR80002-1:2009 | MEDICAL DEVICE SOFTWARE - PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE |
| 09/30186527 DC : 0 | BS EN ISO 23908-1 - SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - PART 1: SHARPS PROTECTION FEATURES FOR SINGLE-USED HYPODERMIC NEEDLES, CATHETERS, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING |
| NF EN 60601-2-66 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS |
| 15/30304642 DC : 0 | BS ISO 11040-8 - PREFILLED SYRINGES - PART 8: REQUIREMENTS AND TEST METHODS FOR FINISHED PRIFILLED SYRINGES |
| 13/30264413 DC : 0 | BS EN ISO 80601-2-72 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| 11/30208525 DC : 0 | BS EN ISO 15197 - IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
| 14/30281859 DC : 0 | BS ISO 5361 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS |
| 09/30176675 DC : 0 | BS EN ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS |
| BS EN ISO 80601-2-69:2014 | Medical electrical equipment Particular requirements for basic safety and essential performance of oxygen concentrator equipment |
| IEC 60601-2-68:2014 | Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
| 13/30233325 DC : 0 | BS EN 45502-1 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| CAN/CSA-C22.2 NO. 80601-2-70:17 | Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (Adopted ISO 80601-2-70:2015, first edition, 2015-01 , with Canadian deviations) |
| BS ISO 27500 : 2016 | THE HUMAN-CENTRED ORGANIZATION - RATIONALE AND GENERAL PRINCIPLES |
| 11/30219211 DC : 0 | BS EN ISO 5840-3 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY MINIMALLY INVASIVE TECHNIQUES |
| BS EN ISO 5361:2016 | Anaesthetic and respiratory equipment. Tracheal tubes and connectors |
| UNE-EN ISO 80369-3:2017 | Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016) |
| 09/30189968 DC : DRAFT JAN 2009 | BS EN 13544-1 AMD1 - RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| BS EN ISO 11073-00103:2017 | Health informatics. Personal health device communication Overview |
| BS EN ISO 18113-5:2011 | In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for self-testing |
| 12/30244415 DC : DRAFT APR 2012 | BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
| 06/30146511 DC : 0 | BS ISO 18113-1 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
| DIN EN 1865-3:2015-05 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
| CEI EN 62083 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS |
| PD IEC/TR 80002-1:2009 | Medical device software Guidance on the application of ISO 14971 to medical device software |
| UNI CEI EN ISO 14971 : 2012 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| 10/30208681 DC : DRAFT SEP 2010 | BS ISO/IEC GUIDE 63 - GUIDE TO THE DEVELOPMENT AND INCLUSION OF SAFETY ASPECTS IN INTERNATIONAL STANDARDS FOR MEDICAL DEVICES |
| NF EN ISO 80601-2-12 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
| CSA C22.2 No. 60601.2.49:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT |
| CSA ISO 27427 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
| BS ISO/IEC 25022:2016 | Systems and software engineering. Systems and software quality requirements and evaluation (SQuaRE). Measurement of quality in use |
| I.S. EN ISO 11608-5:2012 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS (ISO 11608-5:2012) |
| AAMI ISO 14971 : 2007 : R2010 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| CSA C22.2 No. 60601.2.16 : 2014(R2019) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT |
| I.S. EN ISO 7494-1:2011 | DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
| CEI EN 60601-2-16 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT |
| I.S. EN 60601-2-49:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT |
| EN 60601-1-6:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013) |
| EN 60601-2-68:2015 | Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
| ANSI/AAMI/ISO 14708-1:2014 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| I.S. EN ISO 15002:2008 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
| I.S. EN ISO 80601-2-72:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015) |
| ISO 5359:2014 | Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases |
| ISO 14708-5:2010 | Implants for surgery Active implantable medical devices Part 5: Circulatory support devices |
| I.S. EN 60601-2-68:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT |
| ISO 80369-1:2010 | Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements |
| UNE-EN ISO 23908:2013 | Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011) |
| DIN EN ISO 5367:2015-02 | Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
| I.S. EN 60601-1-11:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| PREN ISO 7494-2 : DRAFT 2013 | DENTISTRY - DENTAL UNITS - PART 2: MEDIA CHANNELS AND CONNECTIONS (ISO/DIS 7494-2:2013) |
| DIN EN ISO 5359:2015-02 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014) |
| BS EN ISO 7494-1:2011 | Dentistry. Dental units General requirements and test methods |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 80601-2-70:2015 | Medical electrical equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment |
| ISO 15223-2:2010 | Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation |
| DIN EN ISO 80369-1:2015-09 (Draft) | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| I.S. EN ISO 80601-2-12:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS (ISO 80601-2-12:2011/COR 1:2011) |
| I.S. EN 60601-2-1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-1: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTRON ACCELERATORS IN THE RANGE 1 MEV TO 50 MEV |
| EN ISO 80601-2-12:2011/AC:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS (ISO 80601-2-12:2011/COR 1:2011) |
| ISO 80601-2-12:2011 | Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
| DIN EN ISO 15197:2015-12 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013) |
| UNE-EN ISO 6875:2012 | Dentistry - Patient chair (ISO 6875:2011) |
| DIN EN ISO 11608-1 E : 2015 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS (ISO 11608-1:2014) |
| DIN EN ISO 10079-1:2016-05 | MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015) |
| DIN EN ISO 10079-2:2014-09 | Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014); German version EN ISO 10079-2:2014 |
| UNE-EN ISO 10079-3:2014 | Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014) |
| BS EN 13544-1 : 2007 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| BS EN ISO 10079-3:2014 | Medical suction equipment Suction equipment powered from a vacuum or positive pressure gas source |
| ISO 80601-2-72:2015 | Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
| BS EN ISO 9680:2014 | Dentistry. Operating lights |
| ISO 20072:2009 | Aerosol drug delivery device design verification Requirements and test methods |
| EN 13718-1:2014 | Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances |
| UNE-EN 60601-2-49:2016 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
| ISO 5840-3:2013 | Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques |
| I.S. EN 13718-1:2014 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
| ISO 6875:2011 | Dentistry Patient chair |
| BS EN 285:2015 | Sterilization. Steam sterilizers. Large sterilizers |
| ISO 5361:2016 | Anaesthetic and respiratory equipment — Tracheal tubes and connectors |
| IEC 60601-2-1:2009+AMD1:2014 CSV | Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV |
| ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
| BS EN ISO 6875:2011 | Dentistry. Patient chair |
| IEC 60601-1-10:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers |
| ISO 5840-2:2015 | Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes |
| ISO 11608-1:2014 | Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems |
| UNE-EN ISO 10079-2:2014 | Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014) |
| ISO 18113-3:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use |
| UNE-EN 62083:2010 | Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
| ISO 10079-3:2014 | Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source |
| ISO 23908:2011 | Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
| ISO 9680:2014 | Dentistry Operating lights |
| IEC 62083:2009 | Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
| ISO 27500:2016 | The human-centred organization Rationale and general principles |
| BS EN ISO 15197:2015 | In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus |
| EN ISO 11073-00103:2017 | Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015) |
| EN 1865-2:2010+A1:2015 (edition 2) | Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher |
| EN ISO 80601-2-72:2015 | Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015) |
| EN ISO 18113-5:2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009) |
| EN ISO 5361:2016 | Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016) |
| UNI EN ISO 9680 : 2015 | DENTISTRY - OPERATING LIGHTS |
| EN ISO 15197:2015 | In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013) |
| EN 12342:1998+A1:2009 | Breathing tubes intended for use with anaesthetic apparatus and ventilators |
| EN ISO 10079-2:2014 | Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014) |
| EN ISO 11608-5:2012 | Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012) |
| EN ISO 10079-3:2014 | Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014) |
| EN ISO 23908:2013 | Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011) |
| EN 1865-3:2012+A1:2015 (edition 2) | Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher |
| EN ISO 80369-3:2016 | Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016) |
| EN ISO 20072:2013 | Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009) |
| EN ISO 10524-4:2008 | Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008) |
| EN ISO 11608-1:2015 | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014) |
| EN ISO 18113-1:2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| EN ISO 5367:2014 | Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
| EN ISO 6875:2011 | Dentistry - Patient chair (ISO 6875:2011) |
| BS EN 1865-3 : 2012 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
| 12/30210881 DC : DRAFT APR 2012 | BS EN ISO 5367 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
| BS EN 60601-1-11:2015 | Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| DIN EN ISO 5840-1 E : 2015 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 58401:2015) |
| PREN 45502-1 : DRAFT 2013 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| UNE-EN 60601-2-1:2017 | Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV |
| 13/30263413 DC : 0 | BS EN ISO 7494-2 - DENTISTRY - DENTAL UNITS - PART 2: MEDIA CHANNELS AND CONNECTIONS |
| UNI EN ISO 10524-4 : 2008 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS |
| DIN EN ISO 18113-5:2013-01 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING (ISO 18113-5:2009) |
| UNE-EN ISO 5840-3:2013 | Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
| 14/30273278 DC : 0 | BS EN ISO 18397 - DENTISTRY - POWERED SCALER |
| BS EN ISO 10524-4:2008 | Pressure regulators for use with medical gases Low-pressure regulators |
| DIN EN ISO 18113-1:2013-01 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
| BS EN ISO 18113-1:2011 | In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements |
| IEC TR 62348:2012 | Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition |
| 10/30213842 DC : 0 | BS EN ISO 11608-5 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS |
| CSA C22.2 No. 60601-1-11 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| 16/30310949 DC : 0 | BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES |
| 06/30146518 DC : 0 | BS ISO 18113-3 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE |
| BS EN 80601-2-30 : 2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
| 16/30316718 DC : 0 | BS EN ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
| I.S. EN ISO 5367:2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014) |
| CAN/CSA-Z10524-4:12 (R2017) | Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (Adopted ISO 10524-4:2008, first edition, 2008-06-01, with Canadian deviations) |
| UNI EN ISO 18113-3 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE |
| CSA ISO 14971 : 2007 : R2017 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| CSA ISO 14971 : 2007 : R2012 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| DIN EN ISO 80601-2-69:2014-12 | Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) |
| DIN EN ISO 5367 E : 2015 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014) |
| PREN ISO 11608-1 : DRAFT 2010 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS |
| CSA C22.2 No. 60601-1-10 : 2009 : INC : AMD 1 : 2014 : R201400 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
| EN 60601-1-11:2015 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| IEEE 11073-00103-2012 | Health informatics - Personal health device communication Part 00103: Overview |
| I.S. EN ISO 18113-5:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING (ISO 18113-5:2009) |
| ISO 80601-2-67:2014 | Medical electrical equipment Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment |
| I.S. EN ISO 18113-3:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE (ISO 18113-3:2009) |
| CSA Z5359 : 2016 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES, MEDICAL VACUUM, MEDICAL SUPPORT GASES, AND ANAESTHETIC GAS SCAVENGING SYSTEMS |
| BS EN ISO 10079-1:2015 | Medical suction equipment Electrically powered suction equipment |
| I.S. EN ISO 80601-2-69:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT (ISO 80601-2-69:2014) |
| UNI EN ISO 7494-1 : 2011 | DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
| BS EN ISO 23908:2013 | Sharps injury protection. Requirements and test methods. Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
| ANSI/AAMI/IEC 60601-1-8:2006/A2:2021 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS |
| DIN EN ISO 23908:2013-10 | SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS PROTECTION FEATURES FOR SINGLE-USE HYPODERMIC NEEDLES, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING (ISO 23908:2011) |
| I.S. EN ISO 10079-1:2015 | MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015) |
| EN ISO 7494-1:2011 | Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011) |
| NF EN 60601-2-68 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT |
| ONORM EN ISO 7494-1 : 2011 | DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS (ISO 7494-1:2011) |
| UNI EN ISO 18113-1 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
| 13/30254355 DC : 0 | BS ISO 80601-2-70 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-70: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SLEEP APNEOA BREATHING THERAPY EQUIPMENT |
| UNE-EN 1865-2:2011 | Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher |
| DIN EN ISO 7494-1:2011-11 | DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS (ISO 7494-1:2011) |
| PREN ISO 15197 : DRAFT 2011 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
| UNI EN ISO 15002 : 2008 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
| I.S. EN ISO 5359:2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014) |
| ISO/IEC Guide 63:2012 | Guide to the development and inclusion of safety aspects in International Standards for medical devices |
| I.S. EN ISO 20072:2013 | AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009) |
| ISO 27427:2013 | Anaesthetic and respiratory equipment — Nebulizing systems and components |
| UNE-EN 285:2016 | Sterilization - Steam sterilizers - Large sterilizers |
| UNE-EN ISO 15197:2015 | In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013) |
| ISO 18113-5:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing |
| IEC 60601-2-49:2011 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
| EN 60601-2-66:2015 | Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
| ISO 11608-5:2012 | Needle-based injection systems for medical use Requirements and test methods Part 5: Automated functions |
| BS EN ISO 11608-1:2015 | Needle-based injection systems for medical use. Requirements and test methods Needle-based injection systems |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| ISO 5840-1:2015 | Cardiovascular implants Cardiac valve prostheses Part 1: General requirements |
| ISO 10079-2:2014 | Medical suction equipment Part 2: Manually powered suction equipment |
| EN 45502-1 : 2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| DIN EN ISO 10079-2:2000-03 | MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT (ISO 10079-2:2014) |
| EN 62083:2009 | MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS |
| EN 80601-2-30:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS (IEC 80601-2-30:2009/A1:2013) |
| DIN EN ISO 10079-3:2000-03 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE (ISO 10079-3:2014) |
| EN 60601-2-49:2015 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
| UNE-EN 1865-3:2012 | Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher |
| UNE-EN 13544-1:2007 | Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
| ONORM EN ISO 5367 : 2015 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014) |
| ISO 9241-11:1998 | Ergonomic requirements for office work with visual display terminals (VDTs) Part 11: Guidance on usability |
| AAMI HE48 : 1993 | HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO/IEC Guide 51:2014 | Safety aspects Guidelines for their inclusion in standards |
| ISO/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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