NA 063

DIN Standards Committee Medicine

About NAMed

The DIN Standards Committee Medicine (NAMed) is responsible for the national standardization work and represents the German standardization interests at the European level (CEN) and at the International level (ISO) in the following areas:

  • medical devices;
  • transfusion, infusion and injection;
  • laboratory medicine and clinical chemistry;
  • sterilization, disinfection, sterile supply;
  • medical microbiology and immunology,
  • technical aids for disabled persons,
  • health informatics.

The NAMed covers the development of standards in the mentioned areas with the objective of establishing a high quality level for the standardized products and procedures and thus making an important contribution to patient safety.

The following special fields are excluded from the scope of the NAMed:

  • electromedicine;
  • radiology;
  • rescue services;
  • hospital field

if covered by the scope of the DIN Standards Committee Rescue Services and Hospital (NARK).

How is NAMed composed?

Contact

DIN e. V.

Elisabeth Beck

Alexander-Wellendorff-Str. 2
75172 Pforzheim

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New projects
Document number Begin Title
DIN 32981 2017-03-03 Tactile and acoustic devices for blind and partially sighted persons on traffic signals - Requirements More  Comment 
DIN CEN/ISO TS 22703 2018-02-08 Health informatics - Requirements for Medication Safety Alerts More  Comment 
DIN CEN/ISO TS 22756 2018-02-08 Health Informatics - Requirements for a knowledge base for clinical decision support systems to be used in medication related processes More  Comment 

All projects  

Current Draft Standards
Document number Edition Title
DIN EN ISO 8536-4 2018-04 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO/DIS 8536-4:2018); German and English version prEN ISO 8536-4:2018 More 
DIN EN ISO 12381 2018-03 Health informatics - Time standards for healthcare specific problems (ISO/DIS 12381:2017); English version prEN ISO 12381:2017 More  Comment draft
DIN ISO 13926-1 2018-03 Pen systems - Part 1: Glass cylinders for pen-injectors for medical use (ISO/DIS 13926-1:2018); Text in German and English More  Read draft and comment

All draft standards  

New DIN SPEC
Document number Edition Procedure Title
DIN CEN ISO/TS 19844; DIN SPEC 13261:2017-12 2017-12 VN Health informatics - Identification of medicinal products - Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2016); English version CEN ISO/TS 19844:2017, only on CD-ROM More  Order from Beuth Verlag
DIN CEN ISO/TS 19256; DIN SPEC 13236:2017-06 2017-06 VN Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016); English version CEN ISO/TS 19256:2017 More  Order from Beuth Verlag
DIN CEN ISO/TS 20440; DIN SPEC 13262:2016-12 2016-12 VN Health informatics - Identification of medicinal products - Implementation guide for ISO 11239 data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO/TS 20440:2016); German version CEN ISO/TS 20440:2016 More  Order from Beuth Verlag

All DIN SPEC  

New standards
Document number Edition Title
DIN EN ISO 17664 2018-04 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017); German version EN ISO 17664:2017 More  Order from Beuth Verlag
DIN EN ISO 10555-1 2018-04 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013 + Amd 1:2017); German version EN ISO 10555-1:2013 + A1:2017 More  Order from Beuth Verlag
DIN EN ISO 15378 2018-04 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017); German version EN ISO 15378:2017 More  Order from Beuth Verlag

All standards  

Documents withdrawn without replacement
Document number Deadline for comments Title
DIN 58902 2018-02-28 Haemostaseology - Reference measurement procedure for the determination of batroxobin time More  Comment 
DIN V ENV 12537-1 2018-03-31 Medical informatics - Registration of information objects used for EDI in healthcare - Part 1: The register; English version ENV 12537-1:1997 More  Comment 
DIN CEN/TS 15260 2018-03-31 Health informatics - Classification of safety risks from health informatics products; German and English version CEN/TS 15260:2006 More  Comment 

All withdrawals  

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