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  • BS EN 554:1994

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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. Validation and routine control of sterilization by moist heat

    Available format(s):  Hardcopy, PDF

    Superseded date:  29-09-2006

    Language(s):  English

    Published date:  15-10-1994

    Publisher:  British Standards Institution

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

    Cooperating organizations
    National foreword
    Foreword
    Introduction
    1. Scope
    2. Normative references
    3. Definitions
    4. General
    5. Validation
    6. Process control and monitoring
    7. Product release from sterilization
    Annexes
    A. (informative) Guidance on the application of EN 554
    B. (informative) Bibliography
    National annex NA (informative) Committees responsible
    National annex NB (informative) Cross-references

    Abstract - (Show below) - (Hide below)

    Provides requirements and guidance

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

    Committee CH/198
    Development Note Reviewed and confirmed by BSI, March, 2005. (03/2005) Supersedes 91/57780 DC (09/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    BS EN 866-1:1997 Biological systems for testing sterilizers and sterilization processes General requirements
    BS EN 550:1994 Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization

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

    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    EN 868-5:2009 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
    EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
    EN 868-1 : 1997 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
    EN 724 : 1994 GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES
    EN 1174-1 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS
    BS EN 46002:1997 Specification for application of EN ISO 9002 to the manufacture of medical devices
    EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
    BS 5750-1(1974) : LATEST QUALITY SYSTEMS - SPECIFICATION FOR DESIGN DEVELOPMENT PRODUCTION INSTALLATION AND SERVICING
    BS EN 550:1994 Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization
    BS 5750-0.1(1987) : 1987 QUALITY SYSTEMS - PRINCIPAL CONCEPTS AND APPLICATIONS - GUIDE TO SELECTION AND USE
    EN 868-3:2017 Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
    BS 5750-0.2(1987) : 1987 QUALITY SYSTEMS - PRINCIPAL CONCEPTS AND APPLICATIONS - GUIDE TO QUALITY MANAGEMENT AND QUALITY SYSTEM ELEMENTS
    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
    EN 866-1 : 1997 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - GENERAL REQUIREMENTS
    BS 5750-2(1974) : LATEST QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
    EN 867-1 : 1997 NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS - GENERAL REQUIREMENTS
    ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
    BS EN 556:1995 Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled \'Sterile\'
    BS EN 46001:1997 Specification for application of EN ISO 9001 to the manufacture of medical devices
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
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