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  • BS EN 1174-1:1996

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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. Estimation of the population of micro-organisms on product Requirements

    Available format(s):  Hardcopy, PDF

    Superseded date:  28-04-2006

    Language(s):  English

    Published date:  15-08-1996

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 General
    5 Selection of product
    6 Selection of technique
    7 Validation of technique
    8 Revalidation
    9 Use of technique
    Annexes
    A (informative) Bibliography
    ZA (informative) Clauses of this European Standard addressing
        essential requirements or other provisions of EU
        Directives

    Abstract - (Show below) - (Hide below)

    Specifies general criteria for estimating bioburden on a medical device, raw material or package.

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

    Committee CH/198
    Development Note Reviewed and confirmed by BSI, March, 2005. (03/2005) Supersedes 93/507344 DC. (08/2005)
    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    Status Superseded
    Superseded By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 1174-3:1997 Sterilization of medical devices. Estimation of the population of micro-organisms on product Guide to the methods for validation of microbiological techniques

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

    EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    BS EN ISO 9001:2015 Quality management systems. Requirements
    EN 29004 : 1987 QUALITY MANAGEMENT & QUALITY SYSTEM ELEMENTS - GUIDELINES
    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 ISO 9002:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
    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
    BS EN 46001:1997 Specification for application of EN ISO 9001 to the manufacture of medical devices
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
    EN 45001 : 1989 GENERAL CRITERIA FOR THE OPERATION OF TESTING LABORATORIES
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