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 EN ISO 11199-2 rev 2019-02-18 Walking aids manipulated by both arms - Requirements and test methods - Part 2: Rollators More  Comment 
DIN EN ISO 11199-1 rev 2019-02-18 Walking aids manipulated by both arms - Requirements and test methods - Part 1: Walking frames More  Comment 
DIN 58949-3 2019-02-08 Disinfection - Steam disinfection apparatus - Part 3: Efficiency testing More  Comment 

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Current Draft Standards
Document number Edition Title
DIN EN 14222 2019-04 Stainless steel shell boilers; German and English version prEN 14222:2019 More 
DIN EN ISO 22367 2019-04 Medical laboratories - Application of risk management to medical laboratories (ISO/DIS 22367:2019); German and English version prEN ISO 22367:2019 More 
DIN 58903 2019-04 Haemostaseology - Deficient plasma - Requirements, preparation; Text in German and English More 

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New DIN SPEC
Document number Edition Procedure Title
DIN CEN ISO/TS 20443; DIN SPEC 13263:2018-11 2018-11 VN Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017); English version CEN ISO/TS 20443:2018 More  Order from Beuth Verlag
DIN CEN ISO/TS 20451; DIN SPEC 13264:2018-11 2018-11 VN Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO/TS 20451:2017); English version CEN ISO/TS 20451:2018 More  Order from Beuth Verlag
DIN CEN/TS 16826-3; DIN SPEC 58991 2018-09 VN Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 3: Isolated DNA; German version CEN/TS 16826-3:2018 More  Order from Beuth Verlag

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New standards
Document number Edition Title
DIN EN 868-5 2019-03 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods; German version EN 868-5:2018 More  Order from Beuth Verlag
DIN EN 868-10 2019-03 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods; German version EN 868-10:2018 More  Order from Beuth Verlag
DIN EN 868-8 2019-03 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods; German version EN 868-8:2018 More  Order from Beuth Verlag

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