CSA C22.2 No. 60601.1 : 2014
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
Available format(s)
Hardcopy , PDF
Superseded date
28-01-2022
Language(s)
English
Published date
01-01-2014
Publisher
FOREWORD
INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terminology and definitions
4 General requirements
5 General requirements for testing ME EQUIPMENT
6 Classification of ME EQUIPMENT and ME SYSTEMS
7 ME EQUIPMENT identification, marking and documents
8 Protection against electrical HAZARDS from ME EQUIPMENT
9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and
ME SYSTEMS
10 Protection against unwanted and excessive radiation HAZARDS
11 Protection against excessive temperatures and other HAZARDS
12 Accuracy of controls and instruments and protection against
hazardous outputs
13 HAZARDOUS SITUATIONS and fault conditions
14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
15 Construction of ME EQUIPMENT
16 ME SYSTEMS
17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Annex A (informative) - General guidance and rationale
Annex B (informative) - Sequence of testing
Annex C (informative) - Guide to marking and labelling
requirements for ME EQUIPMENT and ME SYSTEMS
Annex D (informative) - Symbols on marking
Annex E (informative) - Examples of the connection of the
measuring device (MD) for measurement of the
PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT
Annex F (informative) - Suitable measuring supply circuits
Annex G (normative) - Protection against HAZARDS of ignition
of flammable anaesthetic mixtures
Annex H (informative) - PEMS structure, PEMS DEVELOPMENT
LIFE-CYCLE and documentation
Annex I (informative) - ME SYSTEMS aspects
Annex J (informative) - Survey of insulation paths
Annex K (informative) - Simplified PATIENT LEAKAGE CURRENT
diagrams
Annex L (normative) - Insulated winding wires for use
without interleaved insulation
Annex M (normative) - Reduction of pollution degrees
Bibliography
INDEX
INDEX OF ABBREVIATIONS AND ACRONYMS
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS designed to be used in accordance with CSA C22.1 (Canadian Electrical Code, Part I) and CSA Z32.
| DevelopmentNote |
Supersedes CSA C22.2.601.1. (03/2008)
|
| DocumentType |
Standard
|
| Pages |
1062
|
| PublisherName |
Canadian Standards Association
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| CSA Z10524-3 : 2012 : INC : AMD 1 : 2017 : R201700 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
| CSA Z8835.3 : 2008 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS |
| CSA Z23747 : 2008 : R2013 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS |
| CSA Z10535.1 : 2015 | HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
| CSA C22.2 No. 60601-2-6 : 2014 : R2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-6: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MICROWAVE THERAPY EQUIPMENT |
| CSA Z10651-5 : 2008 : R2013 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS |
| 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) |
| CSA Z8185 : 2008(R2013) | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
| CSA Z8185 : 2008 | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
| C22.2 NO. 269.3-17 | Surge protective devices - Type 3 - Cord connected, direct plug-in and receptacle type |
| CSA Z902 : 2010 : R2015 | BLOOD AND BLOOD COMPONENTS |
| CSA Z17510.1 : 2010 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| CSA Z10651-5 : 2008 : INC : UPD 1 : 2011 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS |
| Z364.6-17 | Quality management for kidney dialysis providers |
| CSA C22.2 No. 60601.1.2 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
| CSA C22.2 No. 60601.2.26 : 2014(R2018) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR THE BASIS SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPHS |
| CSA C22.2 No. 60601-2-19 : 2009 : R2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS |
| CSA C22.2 No. 62368-1 : 2014 | AUDIO/VIDEO, INFORMATION AND COMMUNICATION TECHNOLOGY EQUIPMENT - PART 1: SAFETY REQUIREMENTS |
| CSA Z10524-3 : 2012 : R2017 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
| CSA C22.2 No. 60065 : 2016 | AUDIO, VIDEO AND SIMILAR ELECTRONIC APPARATUS - SAFETY REQUIREMENTS |
| CSA SPE 3000 : 2015 | MODEL CODE FOR THE FIELD EVALUATION OF MEDICAL ELECTRICAL EQUIPMENT AND SYSTEMS |
| CSA C22.2 No. 60601-2-21 : 2010FR | MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS |
| CSA C22.2 No. 60601-1-12 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT |
| CSA C22.2 No. 60601.2.47 : 2014(R2018) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-47: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS |
| CSA Z17510.2 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
| 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. 60601-2-21 : 2010 : INC : COR 1 : 2017 : R201400 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS |
| 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 |
| CSA Z18779 : 2008 : R2013 | MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS |
| CSA Z364.2.1:2013 | MONITORING SYSTEMS FOR HEMODIALYSIS EQUIPMENT |
| CAN/CSA-Z7376:12 (R2017) | Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (Adopted ISO 7376:2009, second edition, 2009-08-15, with Canadian deviations) |
| CSA C22.2 No. 60601-2-6 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-6: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MICROWAVE THERAPY EQUIPMENT |
| CSA Z8835.2 : 2008 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS FOR ADULTS |
| 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 |
| CSA Z10524-3 : 2012 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
| CSA Z23747:2008 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS |
| CSA C22.2 No. 269 PACKAGE : 2017 | CONSISTS OF C22.2 NO. 269.1-17 - SURGE PROTECTIVE DEVICES - TYPE 1 - PERMANENTLY CONNECTED; C22.2 NO. 269.2-17 - SURGE PROTECTIVE DEVICES - TYPE 2 - PERMANENTLY CONNECTED; C22.2 NO. 269.3-17 - SURGE PROTECTIVE DEVICES - TYPE 3 - CORD CONNECTED, DIRECT PLUG-IN AND RECEPTACLE TYPE; C22.2 NO. 269.4-17 - SURGE PROTECTIVE DEVICES - TYPE 4 - COMPONENT ASSEMBLIES AND C22.2 NO. 269.5-17 - SURGE |
| CSA Z10651-5 : 2008 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS |
| CSA Z902 : 2010 : INC : UPD 1 : 2012 | BLOOD AND BLOOD COMPONENTS |
| CSA Z7376 : 2012 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION |
| CSA Z32 : 2015 | ELECTRICAL SAFETY AND ESSENTIAL ELECTRICAL SYSTEMS IN HEALTH CARE FACILITIES |
| CSA Z10651-5 : 2008 : R2018 | Lung Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 5: Gas-Powered Emergency Resuscitators |
| CSA C22.2 No. 60601-2-21 : 2010 : R2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS |
| CSA Z902 : 2010 : INC : UPD 2 : 2012 | BLOOD AND BLOOD COMPONENTS |
| CSA Z902 : 2010 : INC : UPD 1 : 2012 : FR | BLOOD AND BLOOD COMPONENTS |
| CSA C22.2 No. 60601-2-19 : 2009 : INC : COR 1 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS |
| 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 |
| 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) |
| CAN/CSA-C22.2 NO. 80601-2-71:17 | Medical electrical equipment — Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment (Adopted IEC 80601-2-71:2015, first edition, 2015-06, with Canadian deviations) |
| Z10535.2-17 | Lifts for the transfer of persons - Installation, use, and maintenance |
| CAN/CSA-C22.2 NO. 60601-2-19-09 (R2018) | Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (Adopted IEC 60601-2-19:2009, second edition, 2009-02) | Appareils électromédicaux - Partie 2-19: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs pour nouveau- nés (norme CEI 60601-2-19:2009 adoptée, deuxième édition, 2009-02) |
| 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) |
| Z364.2.1-13 (R2018) | Monitoring systems for hemodialysis equipment |
| CSA Z18779 : 2008 | MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS |
| 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 |
| CSA Z902 : 2010 | BLOOD AND BLOOD COMPONENTS |
| CSA Z305.13 : 2013(R2018) | PLUME SCAVENGING IN SURGICAL, DIAGNOSTIC, THERAPEUTIC, AND AESTHETIC SETTINGS |
| CSA C22.2 No. 60601.2.40 : 2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT |
| CSA C22.2 No. 60601-2-21 : 2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS |
| IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV | Information technology equipment - Safety - Part 1: General requirements |
| IEC 60112:2003+AMD1:2009 CSV | Method for the determination of the proof and the comparative tracking indices of solid insulating materials |
| IEC 60320-1:2015 | Appliance couplers for household and similar general purposes - Part 1: General requirements |
| IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| IEC 61672-2:2013+AMD1:2017 CSV | Electroacoustics - Sound level meters - Part 2: Pattern evaluation tests |
| ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| IEC 61558-2-1:2007 | Safety of power transformers, power supplies, reactors and similar products - Part 2-1: Particular requirements and tests for separating transformers and power supplies incorporating separating transformers for general applications |
| IEC 60245-1:2003+AMD1:2007 CSV | Rubber insulated cables - Rated voltages up to and including 450/750 V - Part 1: General requirements |
| ISO 7010:2011 | Graphical symbols Safety colours and safety signs Registered safety signs |
| CSA Z305.13 : 2013(R2018) | PLUME SCAVENGING IN SURGICAL, DIAGNOSTIC, THERAPEUTIC, AND AESTHETIC SETTINGS |
| IEC TS 60479-1:2005+AMD1:2016 CSV | Effects of current on human beings and livestock - Part 1: Generalaspects |
| CGA V 1 : 2013 | STANDARD FOR COMPRESSED GAS CYLINDER VALVE OUTLET AND INLET CONNECTIONS |
| IEC 60384-14:2013+AMD1:2016 CSV | Fixed capacitors for use in electronic equipment - Part 14: Sectional specification - Fixed capacitors for electromagnetic interference suppression and connection to the supply mains |
| UL 1439:5ED 2015-04 | Tests for Sharpness of Edges on Equipment |
| IEC 60364-7-710:2002 | Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations |
| IEC 60127-6:2014 | Miniature fuses - Part 6: Fuse-holders for miniature fuse-links |
| IEC 60050-195:1998 | International Electrotechnical Vocabulary (IEV) - Part 195: Earthing and protection against electric shock |
| C22.1-15 | Canadian Electrical Code, Part I (23rd Edition), Safety Standard for Electrical Installations |
| ASME PTC25 : 2014 | PRESSURE RELIEF DEVICES |
| CSA C22.2 No. 49 : 2014 | FLEXIBLE CORDS AND CABLES |
| IEC 60364-4-41:2005+AMD1:2017 CSV | Low voltage electrical installations - Part 4-41: Protection for safety - Protection against electric shock |
| IEC 60073:2002 | Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators |
| IEC 61558-2-4:2009 | Safety of transformers, reactors, power supply units and similar products for supply voltages up to 1 100 V - Part 2-4: Particular requirements and tests for isolating transformers and power supply units incorporating isolating transformers |
| IEC TR 62354:2014 | General testing procedures for medical electrical equipment |
| ISO 23529:2016 | Rubber General procedures for preparing and conditioning test pieces for physical test methods |
| ISO 2882:1979 | Rubber, vulcanized — Antistatic and conductive products for hospital use — Electrical resistance limits |
| ISO 9614-1:1993 | Acoustics — Determination of sound power levels of noise sources using sound intensity — Part 1: Measurement at discrete points |
| IEC 60050-151:2001 | International Electrotechnical Vocabulary (IEV) - Part 151: Electrical and magnetic devices |
| IEC 60884-1:2002+AMD1:2006+AMD2:2013 CSV | Plugs and socket-outlets for household and similar purposes - Part1: General requirements |
| IEC 61000-4-11:2004+AMD1:2017 CSV | Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests |
| IEC 60050-441:1984 | International Electrotechnical Vocabulary (IEV) - Part 441: Switchgear, controlgear and fuses |
| ISO 15001:2010 | Anaesthetic and respiratory equipment Compatibility with oxygen |
| CSA C22.2 No. 21 : 2014 | CORD SETS AND POWER-SUPPLY CORDS |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| 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 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 9170-2:2008 | Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems |
| IEC 60332-2-2:2004 | Tests on electric and optical fibre cables under fire conditions - Part 2-2: Test for vertical flame propagation for a single small insulated wire or cable - Procedure for diffusion flame |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
| NFPA 53 : 2016 | MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES |
| IEC 61558-2-23:2010 | Safety of transformers, reactors, power supply units and combinations thereof - Part 2-23: Particular requirements and tests for transformers and power supply units for construction sites |
| 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 |
| IEC TR 60513:1994 | Fundamental aspects of safety standards for medical electrical equipment |
| IEC 60127-1:2006+AMD1:2011+AMD2:2015 CSV | Miniature fuses - Part 1: Definitions for miniature fuses andgeneral requirements for miniature fuse-links |
| IEC 60851-6:2012 | Winding wires - Test methods - Part 6: Thermal properties |
| IEC 60079-5:2015 RLV | Explosive atmospheres - Part 5: Equipment protection by powder filling "q" |
| IEC 60601-2-22:2007+AMD1:2012 CSV | Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
| IEC 60851-5:2008+AMD1:2011 CSV | Winding wires - Test methods - Part 5: Electrical properties |
| IEC 60227-1:2007 | Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V - Part 1: General requirements |
| IEC 60332-1-2:2004+AMD1:2015 CSV | Tests on electric and optical fibre cables under fire conditions - Part 1-2: Test for vertical flame propagation for a single insulatedwire or cable - Procedure for 1 kW pre-mixed flame |
| ISO 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 32:1977 | Gas cylinders for medical use — Marking for identification of content |
| EN 563:1994/A1:1999/AC:2000 | SAFETY OF MACHINERY - TEMPERATURES OF TOUCHABLE SURFACES - ERGONOMICS DATA TO ESTABLISH TEMPERATURE LIMIT VALUES FOR HOT SURFACES |
| IEC 60601-2-4:2010 | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| IEC 60085:2007 | Electrical insulation - Thermal evaluation and designation |
| ISO/IEC Guide 51:2014 | Safety aspects Guidelines for their inclusion in standards |
| IEC 61558-1:2017 | Safety of transformers, reactors, power supply units and combinations thereof - Part 1: General requirements and tests |
| ISO 3746:2010 | Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane |
| IEC 60447:2004 | Basic and safety principles for man-machine interface, marking and identification - Actuating principles |
| IEC TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
| ISO 780:2015 | Packaging Distribution packaging Graphical symbols for handling and storage of packages |
| 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 |
| MIL-HDBK-217 Revision F:1991 | RELIABILITY PREDICTION OF ELECTRONIC EQUIPMENT |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| IEC 61058-1:2016 | Switches for appliances - Part 1: General requirements |
| NFPA 99 : 2018 | HEALTH CARE FACILITIES CODE |
| IEC 60068-2-2:2007 | Environmental testing - Part 2-2: Tests - Test B: Dry heat |
| IEC 60695-11-10:2013 | Fire hazard testing - Part 11-10: Test flames - 50 W horizontal and vertical flame test methods |
| IEC 60601-1-3:2008+AMD1:2013 CSV | Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| IEC 60079-6:2015 | Explosive atmospheres - Part 6: Equipment protection by liquid immersion "o" |
| IEC 60079-0:2011 | Explosive atmospheres - Part 0: Equipment - General requirements |
| ISO 8041:2005 | Human response to vibration Measuring instrumentation |
| IEC 60851-3:2009+AMD1:2013 CSV | Winding wires - Test methods - Part 3: Mechanical properties |
| IEC 62079:2001 | Preparation of instructions - Structuring, content and presentation |
| ISO 80000-1:2009 | Quantities and units — Part 1: General |
| ISO 13857:2008 | Safety of machinery Safety distances to prevent hazard zones being reached by upper and lower limbs |
| ISO 2878:2017 | Rubber, vulcanized or thermoplastic Antistatic and conductive products Determination of electrical resistance |
| IEC 60086-1:2015 | Primary batteries - Part 1: General |
| CGA V 5 : 2008(R2013) | DIAMETER INDEX SAFETY SYSTEM (NON-INTERCHANGEABLE LOW PRESSURE CONNECTIONS FOR MEDICAL GAS APPLICATIONS) |
| IEC 62353:2014 | Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment |
| IEC 62471:2006 | Photobiological safety of lamps and lamp systems |
| ISO 3864-1:2011 | Graphical symbols Safety colours and safety signs Part 1: Design principles for safety signs and safety markings |
| IEC 60252-1:2010+AMD1:2013 CSV | AC motor capacitors - Part 1: General - Performance, testing andrating - Safety requirements - Guidance for installation and operation |
| ISO 407:2004 | Small medical gas cylinders Pin-index yoke-type valve connections |
| 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 |
| IEC 60050-826:2004 | International Electrotechnical Vocabulary (IEV) - Part 826: Electrical installations |
| IEC 61965:2003 | Mechanical safety of cathode ray tubes |
| ISO 5349-1:2001 | Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General requirements |
| IEC 62133 : 2.0EN+(REDLINE+VERSION) | SECONDARY CELLS AND BATTERIES CONTAINING ALKALINE OR OTHER NON-ACID ELECTROLYTES - SAFETY REQUIREMENTS FOR PORTABLE SEALED SECONDARY CELLS, AND FOR BATTERIES MADE FROM THEM, FOR USE IN PORTABLE APPLICATIONS |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| IEC 60086-4:2014 | Primary batteries - Part 4: Safety of lithium batteries |
| IEC 60317-43:1997+AMD1:2010 CSV | Specifications for particular types of winding wires - Part 43: Aromatic polyimide type wrapped round copper wire, class 240 |
| IEC 61140:2016 | Protection against electric shock - Common aspects for installation and equipment |
| ISO 1853:2011 | Conducting and dissipative rubbers, vulcanized or thermoplastic Measurement of resistivity |
| CSA Z32 : 2015 | ELECTRICAL SAFETY AND ESSENTIAL ELECTRICAL SYSTEMS IN HEALTH CARE FACILITIES |
| IEC 60309-1:1999+AMD1:2005+AMD2:2012 CSV | Plugs, socket-outlets and couplers for industrial purposes - Part 1: General requirements |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| 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 |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| IEC 60601-1-1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
| IEC 60695-1-10:2016 | Fire hazard testing - Part 1-10: Guidance for assessing the fire hazard of electrotechnical products - General guidelines |
| IEC 60445:2017 | Basic and safety principles for man-machine interface, marking and identification - Identification of equipment terminals, conductor terminations and conductors |
| IEC 60664-1:2007 | Insulation coordination for equipment within low-voltage systems - Part 1: Principles, requirements and tests |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
| IEC 60990:2016 | Methods of measurement of touch current and protective conductor current |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 5805:1997 | Mechanical vibration and shock — Human exposure — Vocabulary |
| IEC 60730-1:2013+AMD1:2015 CSV | Automatic electrical controls - Part 1: General requirements |
| ISO 7396-1:2016 | Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum |
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