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:

  • non-active 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 committee’s responsibility also includes the areas of biotechnology and forensics.

The goal is to establish a high quality level for the standardized products and procedures and thus make a decisive contribution to patient safety in the healthcare sector.

The NAMed works closely with other standards committees active in the healthcare sector.

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 13277 2019-12-12 Refrigerators and freezers for the medical sector- Definitions, requirements, testing More  Comment 
ISO 18242 AMD 1 2019-12-11 Kardiovaskuläre Implantate und extrakorporale Systeme - Zentrifugale Blutpumpen - Änderung 1 More  Comment 
DIN CEN ISO/TS 14441 rev 2019-12-10 Health informatics - Security and privacy requirements of EHR systems for use in conformity assessment More  Comment 

All projects  

Current Draft Standards
Document number Edition Title
DIN 13273-7 2020-01 Catheter for medical use - Part 7: Determination of the x-ray attenuation of catheters; requirements and testing More  Read draft and comment
DIN EN ISO 11073-10201 2020-01 Health informatics - Device interoperability - Part 10201: Point-of-care medical device communication - Domain information model (ISO/IEEE/FDIS 11073-10201:2019); English version prEN ISO 11073-10201:2019 More  Comment draft
DIN ISO 13926-3 2020-01 Pen systems - Part 3: Seals for pen-injectors for medical use (ISO 13926-3:2019); Text in German and English More  Read draft and comment

All draft standards  

New DIN SPEC
Document number Edition Procedure Title
DIN CEN/TR 17296; DIN SPEC 13268:2019-12 2019-12 Technical Report Chemical disinfectants and antiseptics - Differentiation of active and non-active substances; German version CEN/TR 17296:2018 More  Order from Beuth Verlag
DIN CEN/TS 17305; DIN SPEC 13255:2019-06 2019-06 VN Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA; German version CEN/TS 17305:2019 More  Order from Beuth Verlag
DIN CEN ISO/TS 20443; DIN SPEC 13263:2018-11 2018-11 VN Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017); English version CEN ISO/TS 20443:2018 More  Order from Beuth Verlag

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New standards
Document number Edition Title
DIN EN ISO 3826-1 2020-01 Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2019); German version EN ISO 3826-1:2019 More  Order from Beuth Verlag
DIN EN ISO 8362-1 2020-01 Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2018); German version EN ISO 8362-1:2019 More  Order from Beuth Verlag
DIN EN ISO 12381 2019-12 Health informatics - Explicit time-related expressions for healthcare-specific problems (ISO 12381:2019); English version EN ISO 12381:2019 More  Order from Beuth Verlag

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