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  • IEC 60601-1-1:2000

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    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    Withdrawn date:  05-03-2013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:  International Electrotechnical Committee

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee TC 62/SC 62A
    Development Note Stability Date: 2013. (10/2012)
    Document Type Standard
    Product Note 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).
    Publisher International Electrotechnical Committee
    Status Withdrawn
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    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)
    NFPA 99 HDBK : 2018 HEALTH CARE FACILITIES CODE HANDBOOK
    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 - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014)
    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 - PART 2: 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 - PART 2-35: 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

    Standards Referencing This Book - (Show below) - (Hide below)

    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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