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Norm
ÖNORM EN ISO 14630
Ausgabedatum: 2009 09 15
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2008)
This ÖNORM specifies general requirements for non-active surgical implants, hereafter referred to as implants. This standard is not applicable to dental implants, dental ...
ZURÜCKGEZOGEN: 2013 04 01
§ Im Gesetz zitiert
Herausgeber:
Austrian Standards International
Format:
Digital | 22 Seiten
Sprache:
Deutsch
| Englisch
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Aktuell Gültig:
Standards mitgestalten:
ICS
This ÖNORM specifies general requirements for non-active surgical implants, hereafter referred to as implants. This standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses. With regard to safety, this standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests required 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
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2012)
Norm
ÖNORM EN ISO 14630
2009 09 15
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2008)
Norm
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ÖNORM EN ISO 14630
2008 04 01
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2008)
Norm
ÖNORM EN ISO 14630
2005 08 01
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2005)
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ÖNORM EN ISO 14630
1998 03 01
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:1997)
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2007 04 27
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 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
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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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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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2020 09 15
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
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Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
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Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2012)
