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  • UNE-EN ISO 16672:2016

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-11-2021

    Language(s):  Spanish, Castilian, English

    Published date:  20-01-2016

    Publisher:  Asociacion Espanola de Normalizacion

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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
       5.1 General
       5.2 Chemical and biological contaminants
       5.3 Chemical description
       5.4 Concentration of the components
       5.5 Density
       5.6 Gaseous expansion
       5.7 Interfacial tension
       5.8 Kinematic viscosity
       5.9 Molecular mass distribution
       5.10 Particulates
       5.11 Refractive index
       5.12 Spectral transmittance
       5.13 Surface tension
       5.14 Vapour pressure
    6 Design evaluation
       6.1 General
       6.2 Evaluation of biological safety
       6.3 Clinical investigation
    7 Sterilization
    8 Product stability
    9 Integrity and performance of the delivery system
    10 Packaging
       10.1 Protection from damage during storage and transport
       10.2 Maintenance of sterility in transit
    11 Information supplied by the manufacturer
    Annex A (normative) Intraocular implantation test
    Annex B (informative) Clinical investigation
    Bibliography

    Abstract - (Show below) - (Hide below)

    Applies to ocular endotamponades (OEs), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina.

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

    Committee CTN 91
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    Status Superseded
    Superseded By
    Supersedes

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

    EN ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
    EN ISO 14155:2011/AC:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
    EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
    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
    EN ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
    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
    EN 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 11135-1:2007)
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    EN 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 (ISO 17665-1:2006)
    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
    EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
    ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
    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
    EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)
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