NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 17664-1 [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 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 11139 2018-08 Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards More 
ISO 11607-1 2019-02 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems More 
ISO 13485 2016-03 Medical devices - Quality management systems - Requirements for regulatory purposes More 
ISO 15223-1 2021-07 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements More 
ISO 15883-4 2018-11 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes More 
ISO 15883-5 2021-07 Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy 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 17664-2 2021-02 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices More