NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 15223-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| DIN ISO 8601-1 | 2020-12 | Date and time - Representations for information interchange - Part 1: Basic rules (ISO 8601-1:2019) More |
| EUV 2017/745 | 2017-04-05 | Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC More |
| EUV 2017/746 | 2017-04-05 | Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU More |
| IEC 62570 | 2014-02 | Standard practice for marking medical devices and other items for safety in the magnetic resonance environment More |
| IEC 80416-1 | 2008-11 | Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration More |
| IEC 80416-3 AMD 1 | 2011-07 | Basic principles for graphical symbols for use on equipment - Part 3: Guidelines for the application of graphical symbols; Amendment 1 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 11607-2 | 2019-02 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes More |
| ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
| ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
