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 ISO 11040-4 2022-05-16 Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO/CD 11040-4:2022) More  Comment 
DIN EN ISO 13131 2022-05-12 Medizinische Informatik - Telemedizinische Dienste - Leitlinien für die Qualitätsplanung More  Comment 
DIN EN ISO 8536-13 rev 2022-05-11 Infusionsgeräte zur medizinischen Verwendung - Teil 13: Graduierte Durchflussregler zur einmaligen Verwendung mit Flüssigkeitskontakt More  Comment 

All projects  

Current Draft Standards
Document number Edition Title
DIN EN ISO 3826-1/A1 2022-07 Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers - Amendment 1 (ISO 3826-1:2019/DAM 1:2022); German and English version EN ISO 3826-1:2019/prA1:2022 More 
DIN EN 17846 2022-06 Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of sporicidal activity against Clostridioides difficile on non-porous surfaces with mechanical action employing wipes in the medical area (4-field test) - Test method and requirements (phase 2, step 2); German and English version prEN 17846:2022 More  Read draft and comment
DIN EN ISO 13408-1 2022-06 Aseptic processing of health care products - Part 1: General requirements (ISO/DIS 13408-1:2021); German and English version prEN ISO 13408-1:2021 More  Read draft and comment

All draft standards  

New publications
Document number Edition Procedure Title
DIN EN ISO 11073-40102 2022-07 Standard Health informatics - Device interoperability - Part 40102: Foundational - Cybersecurity - Capabilities for mitigation (ISO/IEEE 11073-40102:2022); English version EN ISO/IEEE 11073-40102:2022 More  Order from Beuth Verlag
DIN EN ISO 11073-40101 2022-07 Standard Health informatics - Device interoperability - Part 40101: Foundational - Cybersecurity - Processes for vulnerability assessment (ISO/IEEE 11073-40101:2022); English version EN ISO/IEEE 11073-40101:2022 More  Order from Beuth Verlag
DIN CEN/TS 17742 2022-07 VN Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma; German version CEN/TS 17742:2022 More  Order from Beuth Verlag

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Documents withdrawn without replacement
Document number Deadline for comments Title
DIN EN ISO 15223-1/A1 2022-07-31 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016); German and English version EN ISO 15223-1:2016/prA1:2019 More  Comment 

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