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Norm
ÖNORM EN ISO 14630
Issue date: 2008 04 01
Non-active surgical implants - General requirements (ISO 14630:2008)
This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. This International Standard is not applica...
Withdrawn: 2010 01 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 20 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
ICS
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 gives 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 to in level 2 and level 3 standards.
ÖNORM EN ISO 14630
2013 04 01
Non-active surgical implants - General requirements (ISO 14630:2012)
Norm
ÖNORM EN ISO 14630
2009 09 15
Non-active surgical implants - General requirements (ISO 14630:2008)
Norm
ÖNORM EN ISO 14630
2008 04 01
Non-active surgical implants - General requirements (ISO 14630:2008)
Norm
↖
ÖNORM EN ISO 14630
2005 08 01
Non-active surgical implants - General requirements (ISO 14630:2005)
Norm
ÖNORM EN ISO 14630
1998 03 01
Non-active surgical implants - General requirements (ISO 14630:1997)
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Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
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Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (Corrected version 2007-10)
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Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
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Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
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Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
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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 process for medical devices
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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
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Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
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2006 08 17
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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Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
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2007 11 27
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
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Non-active surgical implants - General requirements (ISO 14630:2008)