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    I.S. CEN TS 15277:2006

    Current The latest, up-to-date edition.

    NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2006

    Publisher:  National Standards Authority of Ireland

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

    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Characteristics of injectable implants
      4.1 General
      4.2 Lifetime
          4.2.1 General
          4.2.2 Temporary injectable implants
          4.2.3 Permanent injectable implants
          4.2.4 Injectable implants composed of both temporary
                and permanent materials
      4.3 Clinical Compatibility
      4.4 Post-market surveillance
    Annex A (informative) Overview of examples of injectable implants
    Bibliography

    Abstract - (Show below) - (Hide below)

    Presents characteristics of medical devices that are injectable implants, such as lifetime, migration, displacement, unintended degradation, impurity, infections, bio-incompatibility and clinical incompatibility.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

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

    EN 12442-3 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
    ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    EN ISO 15798:2013/A1:2017 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013/AMD 1:2017)
    ISO 15798:2013 Ophthalmic implants Ophthalmic viscosurgical devices
    ISO 14630:2012 Non-active surgical implants General requirements
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
    EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
    EN 12442-2 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
    EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)
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