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 20696 2020-07-02 Sterile urethral catheters for single use (ISO 20696:2018, Corrected version 2019-12); German version EN ISO 20696:2019 More  Comment 
ISO/AWI TR 23358 2020-07-02 Health informatics - Guidance for establishing standardized measurement data in cardiac examination reports - Japan SEAMAT Case Study More  Comment 
ISO/AWI TR 24288 2020-07-02 ISO/PWI Health informatics - An Indicative Outcome Framework for HI Standardization More  Comment 

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Current Draft Standards
Document number Edition Title
DIN EN ISO 23118 2020-08 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO/DIS 23118:2020); German and English version prEN ISO 23118:2020 More 
DIN EN ISO 23162 2020-08 Basic semen analysis - Specification and test methods (ISO/DIS 23162:2020); German and English version prEN ISO 23162:2020 More 
DIN EN ISO 9999 2020-08 Assistive products - Classification and terminology (ISO/DIS 9999:2020); German and English version prEN ISO 9999:2020 More  Read draft and comment

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New DIN SPEC
Document number Edition Procedure Title
DIN CEN/TS 17288 2020-08 VN Health informatics - The International Patient Summary - Guideline for European Implementation; German version CEN/TS 17288:2020 More  Order from Beuth Verlag
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

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New standards
Document number Edition Title
DIN ISO 13926-3 2020-08 Pen systems - Part 3: Seals for pen-injectors for medical use (ISO 13926-3:2019) More  Order from Beuth Verlag
DIN EN ISO 21043-2 2020-08 Forensic sciences - Part 2: Recognition, recording, collecting, transport and storage of items (ISO 21043-2:2018); German version EN ISO 21043-2:2020 More  Order from Beuth Verlag
DIN 13273-8 2020-07 Catheters for medical use - Part 8: Epidural catheters More  Order from Beuth Verlag

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