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STANDARD

Current

ÖNORM EN ISO 16061

Issue date: 2021 06 15

Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)

This document specifies the general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are supplied after refurbishment. This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves. With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer. This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.

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General information on ÖNORM EN ISO 16061

Format

Digital | 24 Pages

Language

German | English | Download GER/ENG

Publisher

Austrian Standards International

Committee 179 Medical technology

Timeline

An overview of the development of ÖNORM EN ISO 16061 from 1998 til today.

• ÖNORM EN ISO 16061

  2021 06 15 Standard ÖNORM EN ISO 16061, Edition: 2021 06 15

  Instruments for use in association with non-active surgical implants - General requirements (ISO 160...
• ÖNORM EN ISO 16061

  2015 08 15 Standard ÖNORM EN ISO 16061, Edition: 2015 08 15

  Instrumentation for use in association with non-active surgical implants - General requirements (ISO...
• ÖNORM EN ISO 16061

  2010 01 15 Standard ÖNORM EN ISO 16061, Edition: 2010 01 15

  Instrumentation for use in association with non-active surgical implants - General requirements (ISO...
• ÖNORM EN ISO 16061

  2009 04 15 Standard ÖNORM EN ISO 16061, Edition: 2009 04 15

  Instrumentation for use in association with non-active surgical implants - General requirements (ISO...
• ÖNORM EN 12011

  1998 08 01 Standard ÖNORM EN 12011, Edition: 1998 08 01

  Instrumentation to be used in association with non-active surgical implants - General requirements

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Frequently Asked Questions about ÖNORM EN ISO 16061

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer	Titel	Ausgabedatum	Art	Link
Dokumentnummer ISO 10993-1:2018	Titel Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)	Ausgabedatum 2018 08 17	Art Standard	Zur Produktseite
Dokumentnummer ISO 11135:2014	Titel Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices	Ausgabedatum 2014 07 07	Art Standard	Zur Produktseite
Dokumentnummer ISO 11137-1:2006	Titel Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices	Ausgabedatum 2006 04 19	Art Standard	Zur Produktseite
Dokumentnummer ISO 11137-2:2013	Titel Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose	Ausgabedatum 2013 05 21	Art Standard	Zur Produktseite
Dokumentnummer ISO 11137-3:2017	Titel Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control	Ausgabedatum 2017 06 26	Art Standard	Zur Produktseite
Dokumentnummer ISO 11607-1:2019	Titel Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems	Ausgabedatum 2019 01 31	Art Standard	Zur Produktseite
Dokumentnummer ISO 11607-2:2019	Titel Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes	Ausgabedatum 2019 01 31	Art Standard	Zur Produktseite
Dokumentnummer ISO 14155:2020	Titel Clinical investigation of medical devices for human subjects — Good clinical practice	Ausgabedatum 2020 07 28	Art Standard	Zur Produktseite
Dokumentnummer ISO 14937:2009	Titel 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	Ausgabedatum 2009 10 14	Art Standard	Zur Produktseite
Dokumentnummer ISO 14971:2019	Titel Medical devices — Application of risk management to medical devices	Ausgabedatum 2019 12 10	Art Standard	Zur Produktseite
Dokumentnummer ISO 17664:2017	Titel Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices	Ausgabedatum 2017 10 25	Art Standard	Zur Produktseite
Dokumentnummer ISO 17665-1:2006	Titel Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices	Ausgabedatum 2006 08 17	Art Standard	Zur Produktseite
Dokumentnummer ISO 25424:2018	Titel Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices	Ausgabedatum 2018 10 19	Art Standard	Zur Produktseite
Dokumentnummer ISO 80000-1:2009	Titel Quantities and units — Part 1: General	Ausgabedatum 2009 11 17	Art Standard	Zur Produktseite
Dokumentnummer ISO 8601-1:2019	Titel Date and time — Representations for information interchange — Part 1: Basic rules	Ausgabedatum 2019 02 25	Art Standard	Zur Produktseite

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