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 CEN/T? 00216149 2023-01-31 Chemical disinfectants and antiseptics - Information on the preparation of spores and determination/exclusion of sporistatical activity More  Comment 
DIN/TR 13284 2023-01-30 Thrombin generation assay More  Comment 
ISO/AWI 8472-2 2023-01-27 Biotechnology - Data interoperability for stem cell data - Part 2: Key characteristics of stem cell data More  Comment 

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Current Draft Standards
Document number Edition Title
DIN EN ISO 11334-4 2023-03 Assistive products for walking, manipulated by one arm - Requirements and test methods - Part 4: Walking sticks with three or more legs (ISO/DIS 11334-4:2023); German and English version prEN ISO 11334-4:2023 More 
DIN EN ISO 13004 2023-03 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDₘₐₓSD (ISO 13004:2022); German and English version prEN ISO 13004:2023 More 
DIN EN 17180 2023-03 Sterilizers for medical purposes - Low temperature vapourized hydrogen peroxide sterilizers - Requirements and testing; German and English version prEN 17180:2023 More 

All draft standards  

New publications
Document number Edition Procedure Title
DIN EN ISO 21801-2 2023-03 Standard Cognitive accessibility - Part 2: Reporting (ISO 21801-2:2022); German version EN ISO 21801-2:2022 More  Order from Beuth Verlag
DIN CEN ISO/TS 5798 2023-03 VN In vitro diagnostic test systems - Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods (ISO/TS 5798:2022); German version CEN ISO/TS 5798:2022 More  Order from Beuth Verlag
DIN EN ISO 15189 2023-03 Standard Medical laboratories - Requirements for quality and competence (ISO 15189:2022); German version EN ISO 15189:2022 More  Order from Beuth Verlag

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