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:

  • 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 NAMed covers the development of standards in the mentioned areas with the objective of establishing a high quality level for the standardized products and procedures and thus making an important contribution to patient safety.

The following special fields are excluded from the scope of the NAMed:

  • electromedicine;
  • radiology;
  • rescue services;
  • hospital field

if covered by the scope of the DIN Standards Committee Rescue Services and Hospital (NARK).

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 21881 2018-05-22 Sterile packaged ready for filling cartridges More  Comment 
DIN 58950-6 2018-05-22 Sterilization - Steam sterilizers for pharmaceutical products - Part 6: Operation; Text in German and English More  Comment 
DIN ISO 21882 2018-05-22 Sterile packaged ready for filling vials More  Comment 

All projects  

Current Draft Standards
Document number Edition Title
DIN EN ISO 11737-2 2018-07 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO/DIS 11737-2:2018); German and English version prEN ISO 11737-2:2018 More 
DIN 32984 2018-06 Tactile walking surface indicators in public areas More  Read draft and comment
DIN EN 13623 2018-05 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity against Legionella of chemical disinfectants for aqueous systems - Test method and requirements (phase 2, step 1); German and English version prEN 13623:2018 More  Read draft and comment

All draft standards  

New DIN SPEC
Document number Edition Procedure Title
DIN CEN ISO/TS 19844; DIN SPEC 13261:2017-12 2017-12 VN Health informatics - Identification of medicinal products - Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2016); English version CEN ISO/TS 19844:2017, only on CD-ROM More  Order from Beuth Verlag
DIN CEN ISO/TS 19256; DIN SPEC 13236:2017-06 2017-06 VN Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016); English version CEN ISO/TS 19256:2017 More  Order from Beuth Verlag
DIN CEN ISO/TS 20440; DIN SPEC 13262:2016-12 2016-12 VN Health informatics - Identification of medicinal products - Implementation guide for ISO 11239 data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO/TS 20440:2016); German version CEN ISO/TS 20440:2016 More  Order from Beuth Verlag

All DIN SPEC  

New standards
Document number Edition Title
DIN ISO 13926-2 2018-07 Pen systems - Part 2: Plunger stoppers for pen-injectors for medical use (ISO 13926-2:2017) More  Order from Beuth Verlag
DIN EN ISO 11073-10427 2018-06 Health informatics - Personal health device communication - Part 10427: Device specialization - Power status monitor of personal health devices (ISO/IEEE 11073-10427:2018); English version EN ISO 11073-10427:2018 More  Order from Beuth Verlag
DIN EN ISO 13408-2 2018-06 Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018); German version EN ISO 13408-2:2018 More  Order from Beuth Verlag

All standards  

Documents withdrawn without replacement
Document number Deadline for comments Title
DIN EN ISO 15225 2018-05-31 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016); German version EN ISO 15225:2016 More  Comment 
DIN EN ISO 80369-3/A1 2018-07-31 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016/DAM 1:2017); German and English version EN ISO 80369-3:2016/prA1:2017 More  Comment 

All withdrawals  

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