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  • EN 556:1994 + A1:1998

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"

    Available format(s): 

    Superseded date:  01-10-2001

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 Requirements
    Annex
    A (informative) Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies the requirements for a terminally sterilized medical device to be labelled 'STERILE'. Also gives definitions.

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

    Committee TC 204
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

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

    I.S. EN 1283:1996 HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS, HAEMOCONCENTRATORS AND THEIR EXTRACORPOREAL CIRCUITS
    I.S. EN 1616:1997 STERILE URETHRAL CATHETERS FOR SINGLE USE
    I.S. EN 12022:1999 BLOOD GAS EXCHANGERS
    I.S. EN 13503-8:2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
    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
    02/563808 DC : DRAFT SEP 2002 BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    02/563845 DC : DRAFT SEP 2002 BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
    CSA Z10651-4 : 2008 LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
    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
    CSA ISO 5362 : 2014 ANAESTHETIC RESERVOIR BAGS
    BS EN 1782 : 1998 TRACHEAL TUBES AND CONNECTORS
    BS EN 1282-1:1997 Anaesthetic and respiratory equipment. Tracheostomy tubes Tubes for use in adults
    ISO 10651-4:2002 Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
    BS EN 12342 : 1998 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
    BS EN 794-2:1997 Lung ventilators Particular requirements for home care use
    DIN EN 12342:1998-09 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
    DIN EN 12342:2010-01 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
    I.S. EN ISO 10651-4:2009 LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
    DIN EN 13867:2009-09 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
    EN 12011 : 1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    DIN EN 13867:2003-01 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
    EN 13503-8 : 2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
    EN 12181 : 1998 OROPHARYNGEAL AIRWAYS
    EN 12022 : 1999 BLOOD GAS EXCHANGERS
    EN 1283 : 1996 HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS, HAEMOCONCENTRATORS AND THEIR EXTRACORPOREAL CIRCUITS
    EN 12347:1998 Biotechnology - Performance criteria for steam sterilizers and autoclaves
    EN ISO 5366-1:2009 Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)
    EN 12470-2:2000+A1:2009 Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
    11/30252448 DC : 0 BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    ANSI/AAMI/ISO 25539-1:2017 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
    AAMI ISO 12417-1 : 2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
    ISO/TS 15539:2000 Cardiovascular implants Endovascular prostheses
    DIN EN 1782:2009-12 TRACHEAL TUBES AND CONNECTORS
    DIN EN 12470-2:2009-11 Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers (includes Amendment A1:2009)
    BS EN 1174-1:1996 Sterilization of medical devices. Estimation of the population of micro-organisms on product Requirements
    BS EN ISO 10651-4:2002 Lung ventilators Particular requirements for operator-powered resuscitators
    I.S. EN ISO 5366-1:2009 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
    DIN EN 794-1:2001-02 LUNG VENTILATORS - PART 1: PARTICULAR REQUIREMENTS FOR CRITICAL CARE VENTILATORS
    I.S. EN 794-3:1998 LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS
    I.S. EN 12470-2:2000 CLINICAL THERMOMETERS - PART 2: PHASE CHANGE TYPE (DOT MATRIX) THERMOMETERS
    DIN EN ISO 5366-1:2009-07 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
    05/30138123 DC : DRAFT AUG 2005 BS ISO 8836 - SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
    01/563350 DC : DRAFT AUG 2001 BS ISO 25539-1 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
    04/30109833 DC : 0 ISO 8836 - SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
    I.S. EN 12181:1998 OROPHARYNGEAL AIRWAYS
    BS 5724-2.202(1997) : 1997 + A2 2009 LUNG VENTILATORS - PART 1: PARTICULAR REQUIREMENTS FOR CRITICAL CARE VENTILATORS
    BS ISO 25539-1 : 2003 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
    CSA Z10651-4 : 2008 : R2013 LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
    CEI EN 60601-2-12 : 2007 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
    AAMI ISO 5362 : 2006 ANAESTHETIC RESERVOIR BAGS
    DIN EN ISO 10651-4:2009-08 Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
    BS EN 12022:1999 Blood-gas exchangers
    ISO 5366-1:2000 Anaesthetic and respiratory equipment Tracheostomy tubes Part 1: Tubes and connectors for use in adults
    UNE-EN 1782:1998 TRACHEAL TUBES AND CONNECTORS.
    EN 1782:1998+A1:2009 Tracheal tubes and connectors
    UNI EN 12470-2 : 2009 CLINICAL THERMOMETERS - PART 2: PHASE CHANGE TYPE (DOT MATRIX) THERMOMETERS
    UNI EN ISO 5366-1 : 2009 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
    UNI EN 13867 : 2009 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
    UNI EN 12342 : 2009 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
    UNI EN ISO 10651-4 : 2009 LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
    UNI EN 794-1 : 2009 LUNG VENTILATORS - PART 1: PARTICULAR REQUIREMENTS FOR CRITICAL CARE VENTILATORS
    UNI EN 794-3 : 2009 LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS
    UNI EN 1782 : 2009 TRACHEAL TUBES AND CONNECTORS
    I.S. EN 794-2:1997 LUNG VENTILATORS - PARTICULAR REQUIREMENTS FOR HOME CARE USE
    I.S. EN 1819:1998 LARYNGOSCOPES FOR TRACHEAL INTUBATION - PARTICULAR REQUIREMENTS
    I.S. EN 12011:1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    BS EN 60601-2-12:2006 Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators
    MEDDEV 2.5-7 : REV 1 : 1998 GUIDELINES FOR CONFORMITY ASSESSMENT OF BREAST IMPLANTS ACCORDING TO DIRECTIVE 93/42/EEC RELATING TO MEDICAL DEVICES
    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
    CAN/CSA-Z10651-4-08 (R2018) Lung Ventilators - Part 4: Particular Requirements for Operator-Powered Resuscitators (Adopted ISO 10651-4:2002, first edition, 2002-03-01, with Canadian deviations)
    AAMI ISO 10651-4 : 1999 LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
    I.S. EN ISO 25539-1:2017 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
    ISO 5366-3:2001 Anaesthetic and respiratory equipment Tracheostomy tubes Part 3: Paediatric tracheostomy tubes
    I.S. EN 60601-2-12:2006 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
    BS EN 12181:1998 Oropharyngeal airways
    BS EN 1615:2000 Enteral feeding catheters and enteral giving sets for single use and their connectors. Design and testing
    BS EN ISO 10651-6:2009 Lung ventilators for medical use. Particular requirements for basic safety and essential performance Home-care ventilatory support devices
    BS EN 1819:1998 Laryngoscopes for tracheal intubation. Particular requirements
    BS EN 13867 : 2002 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
    BS EN 12011:1998 Instrumentation to be used in association with non-active surgical implants. General requirements
    BS EN 13503-8:2000 Ophthalmic implants. Intraocular lenses Fundamental requirements
    ISO 10651-6:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices
    BS EN 12470-2 : 2001 CLINICAL THERMOMETERS - PHASE CHANGE TYPE (DOT MATRIX) THERMOMETERS
    BS EN 794-3 : 1999 LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS
    BS EN ISO 5366-1:2004 Anaesthetic and respiratory equipment. Tracheostomy tubes Tubes and connectors for use in adults
    EN ISO 10651-4:2009 Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
    EN 1617 : 1997 STERILE DRAINAGE CATHETERS AND ACCESSORY DEVICES FOR SINGLE USE
    EN 13867:2002+A1:2009 Concentrates for haemodialysis and related therapies
    EN 12342:1998+A1:2009 Breathing tubes intended for use with anaesthetic apparatus and ventilators
    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 794-2 : 1997 LUNG VENTILATORS - PARTICULAR REQUIREMENTS FOR HOME CARE USE
    EN 1819 : 1997 LARYNGOSCOPES FOR TRACHEAL INTUBATION - PARTICULAR REQUIREMENTS
    EN 1616:1997/A1:1999 STERILE URETHRAL CATHETERS FOR SINGLE USE
    EN 794-3:1998+A2:2009 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
    EN 794-1:1997+A2:2009 Lung ventilators - Part 1: Particular requirements for critical care ventilators
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    BS EN ISO 25539-1:2017 Cardiovascular implants. Endovascular devices Endovascular prostheses
    07/30147572 DC : DRAFT SEP 2007 BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
    CSA ISO 5367 : 2014 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
    DIN EN ISO 25539-1:2015-07 (Draft) CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
    ISO 5362:2006 Anaesthetic reservoir bags
    CSA Z5361 : 2003 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
    DIN EN 794-3:2009-12 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators; German version EN 794-3:1998+A2:2009
    ISO 25539-1:2017 Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
    BS EN 868-1:1997 Packaging materials and systems for medical devices which are to be sterilized General requirements and test methods
    BS EN 12439:1999 Sterile rectal catheters for single use
    EN 1282-1 : 1996 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - TUBES FOR USE IN ADULTS
    EN 12439:1998 Sterile rectal catheters for single use
    DIN EN ISO 25539-1:2017-09 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
    EN 1615 : 2000 ENTERAL FEEDING CATHETERS AND ENTERAL GIVING SETS FOR SINGLE USE AND THEIR CONNECTORS - DESIGN AND TESTING
    EN 60601-2-12:2006 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators
    UNE-EN 794-3:1999 LUNG VENTILATORS. PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS.
    UNE-EN 13544-1:2007 Respiratory therapy equipment - Part 1: Nebulizing systems and their components

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

    EN 29002 : 1994 QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN PRODUCTION & INSTALLATION
    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    EN 46002 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
    EN 29001 : 1994 QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN DESIGN/DEVELOPMENT, PRODUCTION, INSTALLATION & SERVICING
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
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