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
ISO/CD 11608-3 2018-08-09 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers More  Comment 
ISO/CD 11608-5 2018-08-09 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions More  Comment 
DIN CEN ISO/TS 16775 rev 2018-08-06 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 More  Comment 

All projects  

Current Draft Standards
Document number Edition Title
DIN 58909-1 2018-09 Haemostaseology - Determination of factor VIII coagulant activity (F VIII C) - Part 1: Reference measurement procedure for the one-stage method; Text in German and English More  Comment draft
DIN EN 17272 2018-09 Chemical Disinfectants and Antiseptics - Quantitative Carrier test for Airborne Room Disinfection by Automated Processes - Determination of Bactericidal, Fungicidal, Yeasticidal, Sporicidal, Tuberculocidal, Mycobactericidal, Virucidal and Phagocidal Activities in the Medical Area, Veterinary Area and Food, Industrial, Domestic and Institutional Areas - Test Methods and Requirements (Phase 2, Step 2); German and English version prEN 17272:2018 More  Read draft and comment
DIN EN 17269 2018-09 Health informatics - The Patient Summary for Unscheduled, Cross-border Care; German and English version prEN 17269:2018 More 

All draft standards  

New DIN SPEC
Document number Edition Procedure Title
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
DIN CEN ISO/TS 19293; DIN SPEC 13239:2018-08 2018-08 VN Health Informatics - Requirements for a record of the dispense of a medicinal product (ISO/TS 19293:2018); English version CEN ISO/TS 19293:2018 More  Order from Beuth Verlag
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

All DIN SPEC  

New standards
Document number Edition Title
DIN EN ISO 11073-10418 Berichtigung 1 2018-09 Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor - Technical Corrigendum 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016); English version EN ISO 11073-10418:2014/AC:2016 More  Order from Beuth Verlag
DIN EN ISO 11073-10424 Berichtigung 1 2018-09 Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep apnoea breathing therapy equipment (SABTE) - Technical Corrigendum 1 (ISO/IEEE 11073-10424:2016/Cor 1:2018); English version EN ISO 11073-10424:2016/AC:2018 More  Order from Beuth Verlag
DIN 14142 2018-09 First aid material - First-aid box for fire-brigade motor cars More  Order from Beuth Verlag

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