NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 11135 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
| ISO 14001 | 2015-09 | Environmental management systems - Requirements with guidance for use More |
| ISO 14040 | 2006-07 | Environmental management - Life cycle assessment - Principles and framework 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 14971 | 2019-12 | Medical devices - Application of risk management to medical devices 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 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 |
| ISO 9001 | 2015-09 | Quality management systems - Requirements More |
| ISO/IEC Guide 99 | 2007-12 | International vocabulary of metrology - Basic and general concepts and associated terms (VIM) More |
