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  • ISO 15798:2013

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Ophthalmic implants Ophthalmic viscosurgical devices

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  17-01-2022

    Language(s): 

    Published date:  02-09-2013

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 15798:2013 is applicable to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intra-ocular tissues and to manipulate tissues during surgery.

    ISO 15798:2013 specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices.

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

    Development Note Supersedes ISO/DIS 15798. (09/2013)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By
    Supersedes

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

    I.S. CEN TS 15277:2006 NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS
    AAMI ST72 : 2011 : R2016 BACTERIAL ENDOTOXIN - TEST METHODS, ROUTINE MONITORING AND ALTERNATIVES TO BATCH TESTING
    AAMI ST72 : 2011 BACTERIAL ENDOTOXIN - TEST METHODS, ROUTINE MONITORING AND ALTERNATIVES TO BATCH TESTING
    UNI CEN/TS 15277 : 2007 NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS
    CEN/TS 15277:2006 Non-active surgical implants - Injectable implants

    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 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
    ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
    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 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
    ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
    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
    EN 980:2008 Symbols for use in the labelling of medical devices
    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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