NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 11616 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| EGV 726/2004 | 2004-03-31 | Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency More |
| ISO 21090 | 2011-02 | Health informatics - Harmonized data types for information interchange More |
| ISO/HL7 27951 | 2009-11 | Health informatics - Common terminology services, release 1 More |
| ISO/HL7 27953-1 | 2011-12 | Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 1: Framework for adverse event reporting More |
| ISO/HL7 27953-2 | 2011-12 | Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR More |
| ISO/IEC Guide 99 | 2007-12 | International vocabulary of metrology - Basic and general concepts and associated terms (VIM) More |
| ISO/IEC 11404 | 2007-12 | Information technology - General-Purpose Datatypes (GPD) More |
| ISO/IEC 2382 | 2015-05 | Information technology - Vocabulary More |
| 2001/83/EG | 2001-11-06 | Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use More |
| 2003/63/EG | 2003-06-25 | Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use More |
