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
DIN EN ISO 80601-2-94 2024-05-17 Medical electrical equipment - Part 2-94: Particular requirements for basic safety and essential performance of inhalational therapy nebulizer equipment More  Comment 
ISO/AWI TS 16601 2024-05-14 Health Informatics - Patient Intervention Comparison Outcomes (PICO) information model of TCM clinical studies More  Comment 
ISO/AWI 8961 2024-05-06 Traditional Chinese Medicine--Areca catechu seed More  Comment 

All projects  

Current Draft Standards
Document number Edition Title
DIN EN 14476 2024-07 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 and English version prEN 14476:2024 More 
DIN EN ISO/IEEE 11073-10701 2024-07 Health informatics - Device interoperability - Part 10701: Point-of-Care Medical Device Communication - Metric Provisioning by Participants in a Service-Oriented Device Connectivity (SDC) System (ISO/IEEE FDIS 11073-10701:2024); English version prEN ISO IEEE 11073-10701:2024 More 
DIN EN 16616/A1 2024-06 Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and requirements (phase 2, step 2); German and English version EN 16616:2022/prA1:2024 More  Read draft and comment

All draft standards  

New publications
Document number Edition Procedure Title
DIN EN 455-2 2024-07 Standard Medical gloves for single use - Part 2: Requirements and testing for physical properties; German version EN 455-2:2024 More  Order from DIN Media
DIN EN ISO 11139 2024-06 Standard Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018 + Amd 1:2024); German and English version EN ISO 11139:2018 + A1:2024 More  Order from DIN Media
DIN EN ISO 8362-2 2024-06 Standard Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2024); German version EN ISO 8362-2:2024 More  Order from DIN Media

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Documents withdrawn without replacement
Document number Deadline for comments Title
DIN-Fachbericht CEN/TR 15133 2024-05-31 Nomenclature - Collective terms and codes for groups of medical devices; German version CEN/TR 15133:2005 More  Comment 
DIN 58935-1 2024-07-31 Hämatologie - Determination of the erythrocyte sedimentation rate in blood - Part 1: Selected method More  Comment 

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