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 25379-2 2024-10-31 In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 2: Human RNA examination More  Comment 
ISO/AWI 21474-4 2024-10-31 In vitro diagnostic medical devices - Multiplex molecular testing for nucleic acids - Part 4: Detection of pathogens More  Comment 
ISO/AWI 25379-1 2024-10-31 In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 1: Human DNA examination More  Comment 

All projects  

Current Draft Standards
Document number Edition Title
DIN EN ISO 15621 2025-01 Absorbent incontinence products for urine and/or faeces - General guidelines on evaluation (ISO/DIS 15621:2024); German and English version prEN ISO 15621:2024 More 
DIN EN ISO 17510 2025-01 Medical devices - Sleep apnoea breathing therapy - Masks and application accessories (ISO/DIS 17510:2024); German and English version prEN ISO 17510:2024 More 
DIN 75078-2 2024-12 Motor vehicle for the transport of persons with reduced mobility - Terms, requirements, testing - Part 2: Restraint systems More  Read draft and comment

All draft standards  

New publications
Document number Edition Procedure Title
DIN EN 556-2 2025-01 Standard Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2024 More  Order from DIN Media
DIN EN ISO 7199 2024-12 Standard Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2024); German version EN ISO 7199:2024 More  Order from DIN Media
DIN EN ISO 8536-13 2024-12 Standard Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2024); German version EN ISO 8536-13:2024 More  Order from DIN Media

All publications  

Documents withdrawn without replacement
Document number Deadline for comments Title
DIN 58934-1 2024-12-31 Haematology - Control material for the CBC - Part 1: Control bloods More  Comment 

All withdrawals  

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