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.


Contact

DIN e. V.

Elisabeth Beck

Alexander-Wellendorff-Str. 2
75172 Pforzheim

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New projects
Document number Begin Title
ISO/AWI TS 22220 2023-11-29 Health informatics - Identification of persons and organizations More  Comment 
DIN EN ISO/IEEE 11073-10425 rev 2023-11-20 Health informatics - Device interoperability - Part 10425: Personal Health Device Communication - Device Specialization- Continuous Glucose Monitor (CGM) More  Comment 
ISO/AWI TS 11633-1 2023-11-20 Health informatics - Information security management for remote maintenance of medical devices and medical information systems - Part 1: Requirements and risk analysis More  Comment 

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Current Draft Standards
Document number Edition Title
DIN EN ISO 7396-3 2024-01 Medical gas pipeline systems - Part 3: Proportioning units for the production of synthetic medical air (ISO/DIS 7396-3:2023); German and English version prEN ISO 7396-3:2023 More  Read draft and comment
DIN EN ISO 15002 2024-01 Flow control devices for connection to a medical gas supply system (ISO 15002:2023); German and English version prEN ISO 15002:2023 More  Read draft and comment
DIN 58951 2024-01 Sterilization - Steam sterilizers for laboratory use - Apparatus requirements, requirements on services and installation More  Read draft and comment

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New publications
Document number Edition Procedure Title
DIN EN 17846 2024-01 Standard Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of sporicidal activity against Clostridioides difficile on non-porous surfaces with mechanical action employing wipes in the medical area (4-field test) - Test method and requirements (phase 2, step 2); German version EN 17846:2023 More  Order from Beuth Verlag
DIN EN ISO 11608-3 2024-01 Standard Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022, Corrected version 2023-01); German version EN ISO 11608-3:2022 More  Order from Beuth Verlag
DIN EN ISO 80601-2-72 2023-12 Standard Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2023); German version EN ISO 80601-2-72:2023 More  Order from Beuth Verlag

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