Please select and order
€98.22
excl. VAT
CONFIGURE NOW
Norm
ÖNORM EN ISO 16061
Issue date: 2015 08 15
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
This International Standard specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instru...
Read more
Withdrawn
: 2021 06 15
Publisher:
Austrian Standards International
Format:
Digital | 26 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
This International Standard specifies 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 resupplied after refurbishment.
This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.
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.
This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants.
ÖNORM EN ISO 16061
2021 06 15
Instruments for use in association with non-active surgical implants - General requirements (ISO 160...
Norm
ÖNORM EN ISO 16061
2015 08 15
Instrumentation for use in association with non-active surgical implants - General requirements (ISO...
Norm
↖
ÖNORM EN ISO 16061
2010 01 15
Instrumentation for use in association with non-active surgical implants - General requirements (ISO...
Norm
ÖNORM EN ISO 16061
2009 04 15
Instrumentation for use in association with non-active surgical implants - General requirements (ISO...
Norm
ÖNORM EN 12011
1998 08 01
Instrumentation to be used in association with non-active surgical implants - General requirements
Norm
Norm
ISO 8601:2004
Issue date :
2004 12 03
Data elements and interchange formats — Information interchange — Representation of dates and times
Norm
ISO 11135:2014
Issue date :
2014 07 07
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
Norm
ISO 11137-1:2006
Issue date :
2006 04 19
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Norm
ISO 11137-2:2013
Issue date :
2013 05 21
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Draft
ISO/DIS 11137-3
Issue date :
2015 07 02
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
Norm
ISO 11137-3:2006
Issue date :
2006 04 19
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects
Norm
ISO 14155:2011
Issue date :
2011 01 21
Clinical investigation of medical devices for human subjects — Good clinical practice
Norm
ISO 14971:2007
Issue date :
2007 02 28
Medical devices — Application of risk management to medical devices (Corrected version 2007-09)
Norm
ISO 17664:2004
Issue date :
2004 02 25
Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices
Norm
ISO 17665-1:2006
Issue date :
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
Norm
ISO 11135:2014
Issue date :
2014 07 07
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
Norm
ISO 11137-1:2006
Issue date :
2006 04 19
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Norm
ISO 11137-2:2013
Issue date :
2013 05 21
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Norm
ISO 11137-3:2017
Issue date :
2017 06 26
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
Norm
ISO 14971:2019
Issue date :
2019 12 10
Medical devices — Application of risk management to medical devices
Norm
ISO 17664:2017
Issue date :
2017 10 25
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
Norm
ISO 17665-1:2006
Issue date :
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
Norm
ÖNORM EN ISO 16061
Issue date :
2021 06 15
Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)
Norm
ISO 16061:2015
Issue date :
2015 05 11
Instrumentation for use in association with non-active surgical implants — General requirements