EN ISO 14630:2012
Non-active surgical implants - General requirements

Standard No.
EN ISO 14630:2012
Release Date
2012
Published By
European Committee for Standardization (CEN)
Latest
EN ISO 14630:2012
Replace
FprEN ISO 14630:2012
Scope
This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. This International Standard is not applicable to dental implants, dental restorative materials,transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue.With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.Additional tests are given or referred t

EN ISO 14630:2012 Referenced Document

  • ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
  • ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
  • 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 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 11137-2:2012 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
  • ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
  • ISO 13408-1:2008 Aseptic processing of health care products - Part 1: General requirements
  • ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
  • ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr
  • ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
  • ISO 14971:2007 Medical devices - Application of risk management to medical devices
  • ISO 8601:2004 Data elements and interchange formats - Information interchange - Representation of dates and times

EN ISO 14630:2012 history




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