NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 15378 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| IEC 60300-1 | 2014-05 | Dependability management - Part 1: Guidance for management and application More |
| IEC 60601-1 | 2005-12 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance More |
| IEC 61025 | 2006-12 | Fault tree analysis (FTA) More |
| IEC 61160 | 2005-09 | Design review More |
| IEC 61882 | 2016-03 | Hazard and operability studies (HAZOP studies) - Application guide More |
| ISO 10006 | 2017-11 | Quality management - Guidelines for quality management in projects More |
| ISO 10007 | 2017-03 | Quality management - Guidelines for configuration management More |
| ISO 10012 | 2003-04 | Measurement management systems - Requirements for measurement processes and measuring equipment More |
| ISO 10019 | 2005-01 | Guidelines for the selection of quality management system consultants and use of their services 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 |
