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  • 14/30295064 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS EN ISO 16672 - OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-08-2015

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Intended performance
    5 Design attributes
    6 Design evaluation
    7 Sterilization
    8 Product stability
    9 Integrity and performance of
       the delivery system
    10 Packaging
    11 Information supplied by the
       manufacturer
    Annex A (normative) - Intraocular implantation test
    Annex B (informative) - Clinical investigation
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC

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

    Comment Closes On
    Committee CH/172/7
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 14630:2012 Non-active surgical implants General requirements
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    ISO 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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