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 EN ISO 17117-1 2019-10-18 Health informatics - Terminological resources - Part 1: Characteristics More  Comment 
DIN EN ISO 23533 2019-10-17 Synthetic polyisoprene latex male condoms - Requirements and test methods More  Comment 
ISO/AWI TR 3985 2019-10-10 Biotechnology - Data Publication - Preliminary Considerations and Concepts More  Comment 

All projects  

Current Draft Standards
Document number Edition Title
DIN EN ISO 11073-20701 2019-12 Health informatics - Device interoperability - Part 20701: Point-of-care medical device communication - Service-oriented medical device exchange architecture and protocol binding (ISO/IEEE/FDIS 11073-20701:2019); English version prEN ISO 11073-20701:2019 More 
DIN EN ISO 12967-1 2019-12 Health informatics - Service architecture (HISA) - Part 1: Enterprise viewpoint (ISO/DIS 12967-1:2019); English version prEN ISO 12967-1:2019 More 
DIN EN ISO 12967-2 2019-12 Health informatics - Service Architecture (HISA) - Part 2: Information viewpoint (ISO/DIS 12967-2:2019); English version prEN ISO 12967-2:2019 More 

All draft standards  

New DIN SPEC
Document number Edition Procedure Title
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
DIN CEN ISO/TS 20451; DIN SPEC 13264:2018-11 2018-11 VN Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO/TS 20451:2017); English version CEN ISO/TS 20451:2018 More  Order from Beuth Verlag

All DIN SPEC  

New standards
Document number Edition Title
DIN EN ISO 13120 2019-11 Health informatics - Syntax to represent the content of healthcare classification systems - Classification Markup Language (ClaML) (ISO 13120:2019); German version EN ISO 13120:2019 More  Order from Beuth Verlag
DIN EN ISO 23500-2 2019-11 Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2019); German version EN ISO 23500-2:2019 More  Order from Beuth Verlag
DIN EN ISO 23500-3 2019-11 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2019); German version EN ISO 23500-3:2019 More  Order from Beuth Verlag

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Documents withdrawn without replacement
Document number Deadline for comments Title
DIN 58943-8 2019-11-30 Medical microbiology - Diagnosis of tuberculosis - Part 8: Methods for the determination of susceptibility of tubercle bacilli to chemotherapeutic agents; Text in German and English More  Comment 
DIN 58943 Beiblatt 1 2019-11-30 Medical microbiology - Diagnosis of tuberculosis - Guidance for the specialized use of methods of detection More  Comment 

All withdrawals  

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