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  • BS EN 556-1:2001

    Current The latest, up-to-date edition.

    Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Part 1. Requirements for terminally sterilized medical devices

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-11-2006

    Publisher:  British Standards Institution

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    This European Standard specifies the requirements for a terminally-sterilized medical device to be designated \'STERILE\'. Part2 of this European Standard specifies the requirements for an aseptically processed medical device to be designated \'STERILE\'.

    NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical device as \'STERILE\' is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN550 , EN552 , EN554 , EN ISO14160 and EN ISO14937.

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    Committee CH/198
    Development Note Supersedes 99/565209 DC and BS EN 556 (12/2001)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
    ISO 14160:2011 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
    ISO 13488:1996 Quality systems — Medical devices — Particular requirements for the application of ISO 9002
    EN ISO 13488 : 2000 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    EN ISO 9002:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
    ISO 9002:1994 Quality systems — Model for quality assurance in production, installation and servicing
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
    ISO 9001:2015 Quality management systems — Requirements
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN 980:2008 Symbols for use in the labelling of medical devices
    EN ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
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