• 01/561624 DC : DRAFT APR 2001

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    BS EN ISO 17664 STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE REPROCESSING OF RESTERILIZABLE DEVICES

    Available format(s): 

    Superseded date:  12-03-2004

    Language(s): 

    Published date:  23-11-2012

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Terms and definitions
    3 Information to be provided by the manufacturer
    4 Presentation of the information
    5 Validation of the reprocessing information
      provided
    6 Risk analysis
    Annex A (informative) Commonly utilized reprocessing
             methods
             A.1 General
             A.2 Matrix
    Annex B (informative) An example of reprocessing
             instructions for reusable medical devices
             B.1 General
             B.2 Reprocessing instructions (reusable
                 medical devices)
             Example template
    Annex ZA (informative) Clauses of this European
              Standard addressing essential requirements
              or other provisions of EU Directives
    Bibliography

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

    Comment Closes On
    Committee CH/67
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
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