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 58959-2 2020-03-27 Medical microbiology — Quality management in medical microbiology — Part 2: Requirements for sample collection, transport and acceptance of specimens More  Comment 
ISO/CD 6717 2020-03-24 In vitro diagnostic medical devices - Single-use containers for the collection of specimens, other than blood, from humans More  Comment 
ISO/DIS 22413 2020-03-23 Transfer sets for pharmaceutical preparations - Requirements and test methods More  Comment 

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Current Draft Standards
Document number Edition Title
DIN EN ISO 11608-5 2020-05 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO/DIS 11608-5:2020); German and English version prEN ISO 11608-5:2020 More  Read draft and comment
DIN EN ISO 11608-4 2020-05 Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO/DIS 11608-4:2020); German and English version prEN ISO 11608-4:2020 More  Read draft and comment
DIN EN ISO 11608-3 2020-05 Needle-based injection systems for medical use - Requirements and test methods - Part 3: NIS containers and integrated fluid paths (ISO/DIS 11608-3:2020); German and English version prEN ISO 11608-3:2020 More  Read draft and comment

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New DIN SPEC
Document number Edition Procedure Title
DIN CEN/TS 17390-1 2020-05 VN Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA; German version CEN/TS 17390-1:2020 More  Order from Beuth Verlag
DIN CEN/TS 17390-3 2020-05 VN Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 3: Preparations for analytical CTC staining; German version CEN/TS 17390-3:2020 More  Order from Beuth Verlag
DIN CEN/TS 17390-2 2020-05 VN Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA; German version CEN/TS 17390-2:2020 More  Order from Beuth Verlag

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New standards
Document number Edition Title
DIN EN ISO 11607-2 2020-05 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020 More  Order from Beuth Verlag
DIN EN ISO 8536-4 2020-05 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019); German version EN ISO 8536-4:2020 More  Order from Beuth Verlag
DIN EN ISO 11607-1 2020-05 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019); German version EN ISO 11607-1:2020 More  Order from Beuth Verlag

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