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 8871-2 rev 2018-10-16 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization More  Comment 
ISO/CD 11608-6 2018-10-15 Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery systems More  Comment 
DIN EN ISO 23162 2018-10-04 Basic semen analysis - Specification and test methods More  Comment 

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Current Draft Standards
Document number Edition Title
DIN EN ISO 11073-10425 2018-11 Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM) (ISO/IEEE/FDIS 11073-10425:2018); English version prEN ISO 11073-10425:2018 More  Comment draft
DIN EN ISO 18362 2018-11 Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016); German and English version prEN ISO 18362:2018 More  Read draft and comment
DIN EN 285/A1 2018-10 Sterilization - Steam sterilizers - Large sterilizers; German and English version EN 285:2015/prA1:2018 More  Read draft and comment

All draft standards  

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 ISO 8637-2 2018-12 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018); German version EN ISO 8637-2:2018 More  Order from Beuth Verlag
DIN EN ISO 18472 2018-11 Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2018); German version EN ISO 18472:2018 More  Order from Beuth Verlag
DIN 13155 2018-11 First aid material - Case for first aid material More  Order from Beuth Verlag

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