IEC 60601-1-1:2000
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Withdrawn date
05-03-2013
Language(s)
English - French, English, French, Spanish, Castilian
Published date
12-14-2000
Publisher
FOREWORD
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
3 General requirements
6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
10 Environmental conditions
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
16 ENCLOSURES and PROTECTIVE COVERS
17 Separation
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
22 Moving parts
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE
RADIATION
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE
ANESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER
SAFETY HAZARDS
44 Overflow, spillage, leakage, humidity, ingress of liquids,
cleaning, sterilization, disinfection and compatibility
49 Interruption of the power supply
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST
HAZARDOUS OUTPUT
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL
TESTS
52 Abnormal operation and fault conditions
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
57 MAINS PARTS, components and layout
58 Protective earthing - Terminals and connections
59 Construction and layout
Figure 201 Example of PATIENT ENVIRONMENT
Annex AAA (informative) General guidance and rationale
Annex BBB (informative) Examples of combinations of MEDICAL
ELECTRICAL EQUIPMENT and non-medical electrical equipment
Annex CCC (normative) Normative references
Annex DDD (informative) Bibliography
Annex EEE (normative) Requirements for MULTIPLE PORTABLE
SOCKET-OUTLETS
Annex FFF (informative) Examples of application of MULTIPLE
PORTABLE SOCKET-OUTLETS
Applies to the safety of medical electrical systems, as defined as follows:combination of items of equipment, at least one of which must be medical electrical equipment and inter-connected by functional connection or use of a multiple portable socket-outlet.Describes the safety requirements necessary to provide protection for the patient, the operator and surroundings.Cancels and replaces the first edition published in 1992 and its amendment 1 (1995) and constitutes a technical revision.
| Committee |
TC 62/SC 62A
|
| DevelopmentNote |
Stability Date: 2013. (10/2012)
|
| DocumentType |
Standard
|
| ISBN |
2-8318-5546-2
|
| Pages |
57
|
| ProductNote |
This standard is also refers to IEC 60601-1-4:1996 Amendment 1 (1999),IEC 60825-1:1993 Amendment 1(1997),IEC 61010-1:1990 Amendment 1(1992),IEC 61010-1:1990 Amendment 2 (1995).
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| GOST IEC 60601-1-1 : 2011 | Identical |
| NF EN 60601-1-1 : 2001 | Identical |
| NEN EN IEC 60601-1-1 : 2001 | Identical |
| I.S. EN 60601-1-1:2001 | Identical |
| PN EN 60601-1-1 : 2002 | Identical |
| DIN EN 60601-1-1 : 2002 | Identical |
| VDE 0750-1-1 : 2002 | Identical |
| UNE-EN 60601-1-1:2002 | Identical |
| BS EN 60601-1-1:2001 | Identical |
| CEI EN 60601-1-1 : 2003 | Identical |
| EN 60601-1-1:2001 | Identical |
| CSA C22.2 No. 60601.1.1 : 2002 | Identical |
| JIS T 0601-1-1:2005 | Identical |
| CSA C22.2 No. 60601.1.1 : 2002 : R2006 | Identical |
| BS 5724-1.1(1992) : 1992 AMD 8099 | Identical |
| NEN 10601-1-1 : 1994 AMD 1 1996 | Identical |
| CSA C22.2 No. 60601.1.1 : 2002 : R2011 | Identical |
| GOST R IEC 60601-1-1 : 2007 | Identical |
| CSA C22.2 No. 601.2.33 : 0 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS |
| IEEE 1073.4.1 : 2000 | STANDARD FOR MEDICAL DEVICE COMMUNICATIONS - PHYSICAL LAYER INTERFACE - CABLE CONNECTED |
| BS EN 60601-2-20 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS |
| BS 5724-2.35(1997) : 1997 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR BLANKETS, PADS AND MATTRESSES INTENDED FOR HEATING AND MEDICAL USE |
| 08/30170297 DC : DRAFT MAR 2008 | BS EN 62083 - MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS |
| 03/311987 DC : DRAFT AUG 2003 | BS EN 60601-2-27 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT |
| AAMI ID26:2004 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS |
| CSA Z10651.6 : 2006 : R2015 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| AAMI ID26 : 2004 : R2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS |
| AAMI DF80 : 2003 : R2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC DEFIBRILLATORS [INCLUDING AUTOMATED EXTERNAL DEFIBRILLATORS] |
| CSA Z9919 : 2007 : R2012 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| EN ISO 15254:2009 | Ophthalmic optics and instruments - Electro-optical devices for enhancing low vision (ISO 15254:2009) |
| CSA C22.2 No. 60601.2.12 : 2003 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| 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 |
| I.S. EN 60601- 1:2006&A1:2013&AC:2014&A12:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| BS EN 13976-1:2011 | Rescue systems. Transportation of incubators Interface conditions |
| DIN EN 60601-2-40 : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYGRAPHS AND EVOKED RESPONSE EQUIPMENT |
| AAMI ES60601-1 : 2005 : INC : AMD 1 : 2012 : R201200 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| AAMI ES60601-1 : 2005 : INC : AMD 2 : 2012 : R201200 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| AAMI ES60601-1 : 2005 : R2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| NFPA 99 : 2018 | HEALTH CARE FACILITIES CODE |
| IEC 60601-2-9:1996 | Medical electrical equipment - Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors |
| ISO 8835-5:2004 | Inhalational anaesthesia systems Part 5: Anaesthetic ventilators |
| ISO/IEEE 11073-10418:2014 | Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor |
| BS EN ISO 16201:2006 | Technical aids for disabled persons. Environmental control systems for daily living |
| EN 61223-3-1:1999 | EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - ACCEPTANCE TESTS - IMAGING PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHIC AND RADIOSCOPIC SYSTEMS |
| EN 60601-2-35:1996 | Medical electrical equipment - Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use |
| DIN EN ISO 15254:2009-10 | Ophthalmic optics and instruments - Electro-optical devices for enhancing low vision (ISO 15254:2009) |
| DIN EN ISO 21649:2010-01 | Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006) |
| UNI EN ISO 15254 : 2009 | OPHTHALMIC OPTICS AND INSTRUMENTS - ELECTRO-OPTICAL DEVICES FOR ENHANCING LOW VISION |
| I.S. EN ISO 16201:2006 | TECHNICAL AIDS FOR DISABLED PERSONS - ENVIRONMENTAL CONTROL SYSTEMS FOR DAILY LIVING |
| NF EN ISO 16201 : 2007 | TECHNICAL AIDS FOR PERSONS WITH DISABILITY - ENVIRONMENTAL CONTROL SYSTEMS FOR DAILY LIVING |
| ONORM EN ISO 11608-4 : 2007 | PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS |
| NF EN ISO 21649 : 2009 | NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS |
| NBR ISO 15004-1 : 2015 | OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS |
| DIN EN 60580:2001-12 | Medical electrical equipment - Dose area product meters (IEC 60580:2000); German version EN 60580:2000 |
| ONORM EN ISO 15004-1 : 2009 | OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS |
| BS 5724-1.4(1997) : 1997 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-4: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - GENERAL REQUIREMENTS FOR PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS |
| BS EN 60601-2-38:1997 | Medical electrical equipment. Particular requirements for safety Particular requirements for the safety of electrically operated hospital beds |
| 08/30179595 DC : DRAFT MAR 2008 | BS ISO 13958 - CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES |
| 02/564924 DC : DRAFT NOV 2002 | ISO 21647 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| 03/111613 DC : DRAFT AUG 2003 | BS EN ISO 9919 - MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| ANSI Z80.11:2012 | OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING |
| 04/30112949 DC : DRAFT APR 2004 | IEC 60825-8 ED.2 - SAFETY OF LASER PRODUCTS - PART 8: GUIDELINES FOR THE USE OF MEDICAL LASER EQUIPMENT |
| BS 5724-2.40(1998) : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - PART 2-40: ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT |
| BS 5724-2.38(1997) : 1997 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS |
| BS 5724-2.204(1999) : 1999 | ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS |
| PD IEC/TR 62296:2009 | Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements |
| BS EN 60601-2-40:1998 | Medical electrical equipment. Particular requirements for safety Specification for electromyographs and evoked response equipment |
| CEI EN 60601-2-9 : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS |
| NF EN 60601 2-13 : 2007 AMD 1 2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS |
| BS EN 41003:2009 | Particular safety requirements for equipment to be connected to telecommunication networks and/or a cable distribution system |
| CSA Z17510.2 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
| CSA C22.2 No. 601.2.20 : 1992 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF TRANSPORT INCUBATORS |
| EN 13976-1:2011 | Rescue systems - Transportation of incubators - Part 1: Interface conditions |
| IEC 60364-7-710:2002 | Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations |
| IEC TR 62296:2009 | Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements |
| AAMI ES60601-1 : 2005 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| DIN EN ISO 17510-2:2009-07 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
| DIN EN ISO 17510-1:2009-07 | Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
| BS EN ISO 12866 : 1999 | OPHTHALMIC INSTRUMENTS - PERIMETERS |
| DIN EN ISO 11608-4:2016-03 (Draft) | PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS |
| I.S. EN ISO 21649:2009 | NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS |
| I.S. EN ISO 17510-1:2009 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| EN ISO 17510-1:2009 | Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
| I.S. EN ISO 17510-2:2009 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
| I.S. EN ISO 15254:2009 | OPHTHALMIC OPTICS AND INSTRUMENTS - ELECTRO-OPTICAL DEVICES FOR ENHANCING LOW VISION |
| I.S. EN ISO 10651-6:2009 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| I.S. EN ISO 15004-1:2009 | OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS |
| DIN EN ISO 10651-2:2011-06 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| EN ISO 15004-1:2009 | Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006) |
| NEMA RT 1:2014 | Gating Interface |
| DIN EN 60601-2-35 : 1997 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF BLANKETS, PADS AND MATTRESSES, INTENDED FOR HEATING IN MEDICAL USE |
| 02/562586 DC : DRAFT JUN 2002 | BS EN 60601-1-8 - MEDICAL ELECTRICAL EQUIPMENT - PART 8-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - ALARM SYSTEMS - REQUIREMENTS, TEST AND GUIDELINES - GENERAL REQUIREMENTS AND GUIDELINES FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND IN MEDICAL ELECTRICAL SYSTEMS |
| I.S. EN ISO 9919:2009 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| 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 |
| CSA C22.2 No. 60601.2.9 : 0 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS |
| 11/30243761 DC : 0 | BS ISO 14708-7 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 7: PARTICULAR REQUIREMENTS FOR COCHLEAR IMPLANT SYSTEMS |
| UNI EN ISO 11073-30400 : 2013 | HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30400: INTERFACE PROFILE - CABLED ETHERNET |
| CEI EN 60580 : 2001 | MEDICAL ELECTRICAL EQUIPMENT DOSE AREA PRODUCT METERS |
| BS EN 60601-2-12:2006 | Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators |
| 02/564070 DC : DRAFT SEP 2002 | BS EN 60601-2-17 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE SAFETY OF AUTOMATICALLY-CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT |
| 09/30205924 DC : 0 | BS EN 13976-1 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS |
| BS EN 60601-1-4:1997 | Medical electrical equipment. General requirements for safety Collateral standard. General requirements for programmable electrical medical systems |
| 03/103294 DC : DRAFT JAN 2003 | BS EN ISO 10651-6 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME CARE VENTILATORY SUPPORT DEVICES |
| AAMI DF80:2003 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC DEFIBRILLATORS [INCLUDING AUTOMATED EXTERNAL DEFIBRILLATORS] |
| AAMI ID26 : 2004 : R2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS |
| BS EN ISO 11073-10418:2014 | Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor |
| CSA Z10651.6 : 2006 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| CSA Z9919 :2007 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| VDE 0750-2-40 : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT |
| CEI EN 60601-2-12 : 2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| CSA C22.2 No. 60601.1 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| AAMI ISO 14708-5 : 2010 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES |
| AAMI/IEC TIR62296:2009 | |
| EN 60601-2-40:1998 | Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment |
| UNE-EN 13976-1:2011 | Rescue systems - Transportation of incubators - Part 1: Interface conditions |
| ISO 14708-2:2012 | Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers |
| DIN EN ISO 10651-6:2011-06 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| DIN EN ISO 12866:2009-03 | OPHTHALMIC INSTRUMENTS - PERIMETERS |
| BS EN ISO 9919:2009 | Medical electrical equipment. Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
| BS EN ISO 21649:2009 | Needle-free injectors for medical use. Requirements and test methods |
| ISO 10651-2:2004 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients |
| DIN EN 13976-1 E : 2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS |
| ISO 21649:2006 | Needle-free injectors for medical use — Requirements and test methods |
| UNE-EN 60601-1:2008 | Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance |
| EN 41003:2008 | Particular safety requirements for equipment to be connected to telecommunication networks and/or a cable distribution system |
| UNI EN ISO 16201 : 2007 | TECHNICAL AIDS FOR DISABLED PERSONS - ENVIRONMENTAL CONTROL SYSTEMS FOR DAILY LIVING |
| UNI EN ISO 10651-2 : 2009 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR- DEPENDENT PATIENTS |
| UNI EN ISO 8835-5 : 2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHETIC VENTILATORS |
| UNI EN ISO 17510-2 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
| UNI EN ISO 12866 : 2009 | OPHTHALMIC INSTRUMENTS - PERIMETERS |
| I.S. EN ISO 11608-4:2007 | PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS |
| EN ISO 9919:2009 | Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005) |
| UNI EN ISO 9919 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| UNI EN ISO 10651-6 : 2009 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| UNI EN ISO 21649 : 2009 | NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS |
| 13/30250915 DC : 0 | BS EN 62353 - MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT |
| BS ISO 15752:2000 | Ophthalmic instruments. Endoilluminators. Fundamental requirements and test methods for optical radiation safety |
| BS EN ISO 11073-30400:2012 | Health informatics. Point-of-care medical device communication Interface profile. Cabled Ethernet |
| BS 5724-2.44(1999) : 1999 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY |
| UNI EN ISO 15004-1 : 2009 | OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS |
| BS EN 60118-14:1998 | Hearing aids Specification of a digital interface device |
| 04/30103854 DC : DRAFT JUN 2004 | ISO 15004-1 - OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS |
| BS 5724-2.18(1997) : 1997 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ENDOSCOPIC EQUIPMENT |
| 03/103293 DC : DRAFT JAN 2003 | BS EN ISO 10651-2 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| 01/561640 DC : DRAFT APR 2001 | BS EN ISO 8835-4 - INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
| CSA Z10651.2 : 2006 : R2015 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| CSA Z10651.2: 2006 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| ANSI Z80.11 : 2012 : R2017 | OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING |
| CSA Z8835.5 : 2006 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHETIC VENTILATORS |
| NF EN 60601-1-4 : 1999 AMD 1 2005 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-4: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS |
| I.S. EN ISO 11073-10418:2014 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014, CORRECTED VERSION 2014-05-01) |
| ISO 14708-5:2010 | Implants for surgery Active implantable medical devices Part 5: Circulatory support devices |
| I.S. EN 60601-2-40:1999 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT |
| UNI EN ISO 17510-1 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| NF EN 60601-2-40 : 2000 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENTS |
| PD IEC/TR 62809:2013 | Summary of requirements and tests for products in the scope of IEC 60601-2-66 |
| UNI EN 13976-1 : 2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS |
| I.S. EN 60580:2000 | MEDICAL ELECTRICAL EQUIPMENT - DOSE AREA PRODUCT METERS |
| I.S. EN 60601-2-12:2006 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| I.S. EN 60601-2-38:1998 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS |
| DIN EN ISO 8835-5:2009-07 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHESIA VENTILATORS |
| DIN EN ISO 21649 E : 2010 | NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS |
| DIN EN ISO 16201:2006-12 | Technical aids for persons with disability - Environmental control systems for daily living (ISO 16201:2006) |
| DIN EN ISO 15004-1:2009-07 | Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006); German version EN ISO 15004-1:2009 |
| BS EN 60601-1 : 2006 | MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| BS EN ISO 17510-1:2009 | Sleep apnoea breathing therapy Sleep apnoea breathing therapy equipment |
| ISO 17510-2:2007 | Sleep apnoea breathing therapy Part 2: Masks and application accessories |
| EN 60580:2000 | Medical electrical equipment - Dose area product meters |
| BS EN ISO 10651-6:2009 | Lung ventilators for medical use. Particular requirements for basic safety and essential performance Home-care ventilatory support devices |
| ISO 9919:2005 | Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
| BS EN ISO 15004:1998 | Ophthalmic instruments. Fundamental requirements and test methods |
| BS EN ISO 15254:2009 | Ophthalmic optics and instruments. Electro-optical devices for enhancing low vision |
| BS EN ISO 11608-4:2007 | Pen-injectors for medical use Requirements and test methods for electronic and electromechanical pen-injectors |
| ISO 15004-1:2006 | Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments |
| IEC 60580:2000 | Medical electrical equipment - Dose area product meters |
| ISO 11608-4:2006 | Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechanical pen-injectors |
| BS EN ISO 10651-2:2004 | Lung ventilators for medical use. Particular requirements for basic safety and essential performance Home care ventilators for ventilator-dependent patients |
| ISO 10651-6:2004 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices |
| ISO 15254:2009 | Ophthalmic optics and instruments Electro-optical devices for enhancing low vision |
| BS EN 740:1999 | Anaesthetic workstations and their modules. Particular requirements |
| ISO/IEEE 11073-30400:2012 | Health informatics — Point-of-care medical device communication — Part 30400: Interface profile — Cabled Ethernet |
| BS EN ISO 11073-30200 : 2005 | HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30200: TRANSPORT PROFILE - CABLE CONNECTED |
| ISO 12866:1999 | Ophthalmic instruments Perimeters |
| ISO 16201:2006 | Technical aids for persons with disability — Environmental control systems for daily living |
| NF EN ISO 17510-1 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| EN 60601-2-9:1996/corrigendum:1996 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS |
| EN ISO 15004 : 1997 | OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS |
| EN ISO 21649:2009 | Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006) |
| EN ISO 12866:1999/A1:2008 | Ophthalmic instruments - Perimeters - Amendment 1 (ISO 12866:1999/Amd1:2008) |
| EN ISO 11073-30200:2005/A1:2015 | HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30200: TRANSPORT PROFILE - CABLE CONNECTED (ISO/IEEE 11073- 30200:2004/AMD 1:2015) |
| EN ISO 10651-2:2009 | Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004) |
| EN ISO 16201:2006 | Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006) |
| EN ISO 10651-6:2009 | Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004) |
| EN ISO 8835-5:2009 | Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004) |
| EN ISO 17510-2:2009 | Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007) |
| EN ISO 11073-30400:2012 | Health informatics - Point-of-care medical device communication - Part 30400: Interface profile - Cabled Ethernet (ISO 11073-30400:2012) |
| EN ISO 8612:2009 | Ophthalmic instruments - Tonometers (ISO 8612:2009) |
| EN ISO 11608-4:2007 | Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006) |
| BS EN 60601-2-35:1997 | Medical electrical equipment. Particular requirements for safety Specification for blankets, pads and mattresses intended for heating in medical use |
| BS 5724-2.39(1999) : 1999 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR PERITONEAL DIALYSIS EQUIPMENT |
| I.S. EN ISO 8835-5:2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHESIA VENTILATORS |
| I.S. EN ISO 10651-2:2009 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| 00/560888 DC : APR 2000 | IEC 60601-1-2 EDITION 2 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS |
| BS EN 60580:2000 | Dose area product meters |
| CSA Z10651.6 :2006 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| CSA Z17510.1 : 2010 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| BS IEC 60825-8:1999 | Safety of laser products Guidelines for the safe use of medical laser equipment |
| I.S. EN ISO 11073-30400:2012 | HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30400: INTERFACE PROFILE - CABLED ETHERNET (ISO 11073-30400:2012) |
| IEC 60118-14:1998 | Hearing aids - Part 14: Specification of a digital interface device |
| BIS IS/ISO 14708-1 : 2000 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| AAMI RD61 : 2006 | CONCENTRATES FOR HEMODIALYSIS |
| IEEE 11073-10418-2011 | IEEE Standard - Health informatics--Personal health device communication Part 10418: Device specialization--International Normalized Ratio (INR) monitor |
| CEI 62-143 : 2007 | MAPPING BETWEEN THE CLAUSES OF THE THIRD EDITION OF IEC 60601-1 AND THE 1988 EDITION AS AMENDED |
| CEI EN 60601-2-40 : 1999 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT |
| DIN EN 13976-1:2016-03 (Draft) | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS |
| I.S. EN 13976-1:2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS |
| I.S. EN 60601-2-9:1998 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS |
| IEC TR 62809:2013 | Summary of requirements and tests to products in the scope of IEC 60601-2-66 |
| EN ISO 11073-10418:2014/AC:2016 | Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor - Technical Corrigendum 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016) |
| BS EN ISO 17510-2:2009 | Sleep apnoea breathing therapy Masks and application accessories |
| IEC 61223-3-1:1999 | Evaluation and routine testing in medical imaging departments - Part 3-1: Acceptance tests - Imaging performance of X-ray equipment for radiographic and radioscopic systems |
| ISO 17510-1:2007 | Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment |
| BS EN ISO 8835-5:2009 | Inhalational anaesthesia systems Anaesthesia ventilators |
| BS EN ISO 15004-1:2009 | Ophthalmic instruments. Fundamental requirements and test methods General requirements applicable to all ophthalmic instruments |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| EN 60601-2-38:1996/A1:2000 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS |
| DIN EN 13976-1:2011-08 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS |
| EN 60118-14:1998 | Hearing aids - Part 14: Specification of a digital interface |
| NF EN ISO 15004-1 : 2009 | OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS |
| NF EN 60580 : 2004 | MEDICAL ELECTRICAL EQUIPMENT - DOSE AREA PRODUCT METERS |
| EN 60601-1-4:1996/A1:1999 | MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS |
| EN 60601-2-12:2006 | Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators |
| IEC 60950:1999 | Safety of information technology equipment |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60884-1:2002+AMD1:2006+AMD2:2013 CSV | Plugs and socket-outlets for household and similar purposes - Part1: General requirements |
| ISO 8359:1996 | Oxygen concentrators for medical use Safety requirements |
| ISO 7767:1997 | Oxygen monitors for monitoring patient breathing mixtures — Safety requirements |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
| ISO 9918:1993 | Capnometers for use with humans Requirements |
| ISO 10079-1:2015 | Medical suction equipment Part 1: Electrically powered suction equipment |
| ISO 8185:2007 | Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| IEC 60989:1991 | Separating transformers, autotransformers, variable transformersand reactors. |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
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