NA 176

DIN Standards Committee Health Technologies

About NAGesuTech

You were not looking for NAGesuTech but for NAMed or NARK?

You've come to the right place: both covered similar topics and so NAMed and NARK were merged in 2023 to form the new DIN Standards Committee for Healthcare Technologies (NAGesuTech). This creates new synergies and expands our network. All committees, standards, drafts and projects from the former NAMed and NARK can now be found here. 

The Health Technologies Standards Committee (NAGesuTech) at DIN, the German Institute for Standardization, is responsible for national standardization and represents German standardization interests at European (CEN) and international (ISO) level.

Health technologies include products, processes and procedures in the fields of research, preclinical, clinical, home therapy and other health sectors. The standards committee deals in particular with the areas of transfusion, infusion, injection, prevention, respiratory systems, laboratory medicine, sterilization, disinfection, sterile supply, hospital cleaning, rescue systems, aids for participation in everyday life - especially for people with disabilities - health informatics, biotechnology, forensics, and systems and processes in healthcare.

For some of these standardization activities, there is close cooperation with the DKE German Commission for Electrical, Electronic & Information Technologies in DIN and VDE.

Standardization in these areas is intended to support state-of-the-art medical care and the safe use of products, processes and procedures that meet medical and patient needs.

How is NAGesuTech composed?

Contact

DIN e. V.
Elisabeth Beck

Alexander-Wellendorff-Str. 2
75172 Pforzheim

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New projects
Document number Begin Title
ISO/AWI 11249 2024-10-01 Copper-bearing intrauterine contraceptive devices - Guidance on the design, execution, analysis and interpretation of clinical studies More  Comment 
ISO/AWI 18972 2024-09-30 Medical devices - Infusate compatibility - Requirements and assessment methods More  Comment 
ISO/AWI 25347 2024-09-27 Biotechnology - Bioprocessing - General requirements for purification of extracellular vesicles More  Comment 

All projects  

Current Draft Standards
Document number Edition Title
DIN EN ISO 80601-2-69 2024-11 Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment (ISO/DIS 80601-2-69:2024); German and English version prEN ISO 80601-2-69:2024 More  Read draft and comment
DIN EN ISO 80601-2-67 2024-10 Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment (ISO/DIS 80601-2-67:2024); German and English version prEN ISO 80601-2-67:2024 More  Read draft and comment
DIN EN ISO 8536-16 2024-09 Infusion equipment for medical use - Part 16: Infusion sets for single use with volumetric infusion controllers (ISO/DIS 8536-16:2024); German and English version prEN ISO 8536-16:2024 More  Read draft and comment

All draft standards  

New publications
Document number Edition Procedure Title
DIN CEN ISO/TS 17251 2024-11 VN Health informatics - Business requirements for a syntax to exchange structured dose information for medicinal products (ISO/TS 17251:2023); English version CEN ISO/TS 17251:2023 More  Order from DIN Media
DIN EN ISO 15378/A1 2024-11 Standard Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Amendment 1: Climate action changes (ISO 15378:2017/Amd 1:2024); German version EN ISO 15378:2017/A1:2024 More  Order from DIN Media
DIN EN ISO 5361 2024-11 Standard Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2023, Corrected version 2023-11); German version EN ISO 5361:2023 More  Order from DIN Media

All publications  

Documents withdrawn without replacement
Document number Deadline for comments Title
DIN 13156 2024-10-31 Single patient first aid kit for mass casualties and catastrophes More  Comment 
DIN 58956-3 2024-10-31 Medical microbiology; medical microbiological laboratories; requirements for the organization scheme More  Comment 
DIN 58956-2 2024-10-31 Medical microbiology; medical microbiological laboratories; requirements for equipment More  Comment 

All withdrawals  

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