DIN EN ISO 16061:2015
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015); German version EN ISO 16061:2015

Standard No.

DIN EN ISO 16061:2015

Release Date

2015

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN ISO 16061 E:2020-02

Latest

DIN EN ISO 16061:2015

DIN EN ISO 16061:2020

DIN EN ISO 16061:2021-06

Replace

DIN EN ISO 16061:2010 DIN EN ISO 16061:2013

DIN EN ISO 16061:2015 Referenced Document

• DIN EN ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014); German version EN ISO 11135:2014
• DIN EN ISO 11137-1:2013 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006 + Amd 1:2013); German version EN ISO 11137-1:2006 + A1:2013
• DIN EN ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2013
• DIN EN ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006) English version of DIN EN ISO 11137-3:2006-07
• DIN EN ISO 11607-1:2014 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1:2014); German version EN ISO 11607-1:2009 + A1:2014
• DIN EN ISO 11607-2:2014 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006 + Amd 1:2014); German version EN ISO 11607-2:2006 + A1:2014
• DIN EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor. 1:2011); German version EN ISO 14155:2011 + AC:2011
• DIN EN ISO 14971:2013 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012
• DIN EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004); German version EN ISO 17664:2004
• DIN EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006); English version of DIN EN ISO 17665-1:2006-11
• DIN EN ISO 80000-1:2013 Quantities and units - Part 1: General (ISO 80000-1:2009 + Cor 1:2011); German version EN ISO 80000-1:2013

DIN EN ISO 16061:2015 history

• 2021 DIN EN ISO 16061:2021 Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021); German version EN ISO 16061:2021
• 1970 DIN EN ISO 16061 E:2020-02
• 2015 DIN EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015); German version EN ISO 16061:2015
• 0000 DIN EN ISO 16061:2013
• 2010 DIN EN ISO 16061:2010 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15); German version EN ISO 16061:2009