NA 027

DIN Standards Committee Optics and Precision Mechanics

DIN EN ISO 16061 [Withdrawn] references following documents:

Document number Edition Title
ISO 11135 2014-07 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices More 
ISO 11137-1 2006-04 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices More 
ISO 11137-2 2013-06 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose More 
IEC 60068-2-27 2008-02 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock More 
IEC 60068-2-31 2008-05 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens More 
IEC 60068-2-47 2005-04 Environmental testing - Part 2-47: Test - Mounting of specimens for vibration, impact and similar dynamic tests More 
ISO 10993-13 2010-06 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices More 
ISO 10993-14 2001-11 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics More 
ISO 10993-7 2008-10 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals More 
ISO 11140-1 2014-11 Sterilization of health care products - Chemical indicators - Part 1: General requirements More