NA 027

DIN Standards Committee Optics and Precision Mechanics

DIN EN ISO 14630 [CURRENT] references following documents:

Document number Edition Title
ISO 10993-7 2008-10 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals 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 14937 2009-10 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 More 
ISO 22442-3 2007-12 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents More 
DIN EN ISO 14937 2010-03 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 (ISO 14937:2009); German version EN ISO 14937:2009 More 
DIN EN ISO 22442-3 2008-03 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007); German version EN ISO 22442-3:2007 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 14602 2010-04 Non-active surgical implants - Implants for osteosynthesis - Particular requirements More