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 80369-7 rev 2019-08-13 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors with 6 % (Luer) taper for intravascular or hypodermic applications More  Comment 
ISO/DIS 80369-7 2019-08-05 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors with 6 % (Luer) taper for intravascular or hypodermic applications More  Comment 
DIN EN ISO 17117-2 2019-07-23 Health informatics - Terminological resources - Part 2: Capability More  Comment 

All projects  

Current Draft Standards
Document number Edition Title
DIN EN 17430 2019-09 Chemical disinfectants and antiseptics - Hygienic handrub virucidal - Test method and requirements (phase 2/step 2); German and English version prEN 17430:2019 More  Read draft and comment
DIN 58279 2019-09 First aid box scissors More  Read draft and comment
DIN 58949-3 2019-09 Disinfection - Steam disinfection apparatus - Part 3: Efficiency testing More  Read draft and comment

All draft standards  

New DIN SPEC
Document number Edition Procedure Title
DIN CEN/TS 17305; DIN SPEC 13255:2019-06 2019-06 VN Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA; German version CEN/TS 17305:2019 More  Order from Beuth Verlag
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

All DIN SPEC  

New standards
Document number Edition Title
DIN EN 14476 2019-10 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1); German version EN 14476:2013+A2:2019 More  Order from Beuth Verlag
DIN EN ISO 11073-10425 2019-09 Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM) (ISO/IEEE 11073-10425:2019); English version EN ISO 11073-10425:2019 More  Order from Beuth Verlag
DIN EN ISO 8871-3 2019-08 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count (ISO 8871-3:2003 + Amd 1:2018); German version EN ISO 8871-3:2004 + A1:2019 More  Order from Beuth Verlag

All standards  

Documents withdrawn without replacement
Document number Deadline for comments Title
DIN 58959-19 2019-09-30 Quality management in medical microbiology - Part 19: Requirements for the use of control strains for the examination of fungi More  Comment 
DIN 58959-18 2019-09-30 Quality management in medical microbiology - Part 18: Requirements for the use of control strains for the examination of mycoplasms More  Comment 
DIN 58959-7 2019-09-30 Quality management in medical microbiology - Part 7: General requirements for the use of control strains More  Comment 

All withdrawals  

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