NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 11135 [CURRENT] references following documents:

Document number Edition Title
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 14971 2019-12 Medical devices - Application of risk management to medical devices More 
ISO 15883-1 2006-04 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests More 
ISO 15883-1 AMD 1 2014-07 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests; Amendment 1 More 
ISO 15883-2 2006-04 Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. More 
ISO 15883-3 2006-04 Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers More 
ISO 15883-4 2018-11 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes More 
ISO 15883-6 2011-04 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment More 
ISO 15883-7 2016-02 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment 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