About
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Secretariat: DIN (Germany)
Committee Manager: -
Chairperson (until end 2024):Mr Marc von Pawlowski
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ISO Technical Programme Manager [TPM]:ISO Editorial Manager [EM]:
- Creation date: 1951
Scope
Standardization of containers (such as infusion bottles and bags, injection vials, ampoules, glass cylinders, cartridges, prefillable syringes, etc.) application systems (such as giving sets, non-electrically driven portable infusion devices, blood collection systems, etc.) and accessories for infusion, transfusion, injection and blood processing in blood banks, terms, definitions, requirements and test methods for these devices, specifications and test methods for quality and performance of their materials and components (such as elastomeric closures, caps and ports, pipettes, etc.) and quality management systems for primary packaging materials.
Excluded:
- performance requirements of metered devices and supplies intended for self-administration of medicinal products, non-prefilled syringes and needles and intravascular catheters, covered by ISO/TC 84;
- devices intended for respiratory therapy, covered by ISO/TC 121;
- dental cartridge syringe holder, covered by ISO/TC 106.
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This committee contributes with 105 standards to the following Sustainable Development Goals:
Liaison Committees to ISO/TC 76
The committees below can access the documents of ISO/TC 76:
Reference | Title | ISO/IEC |
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IEC/SC 62D | Particular medical equipment, software, and systems | IEC |
ISO/TC 48 | Laboratory equipment | ISO |
ISO/TC 48/SC 7 | Non-measuring equipment made of glass, plastic and ceramics | ISO |
ISO/TC 61/SC 9 | Thermoplastic materials | ISO |
ISO/TC 63 | Glass containers | ISO |
ISO/TC 84 | Devices for administration of medicinal products and catheters | ISO |
ISO/TC 106/SC 4 | Dental instruments | ISO |
ISO/TC 150/SC 2 | Cardiovascular implants and extracorporeal systems | ISO |
ISO/TC 176/SC 2 | Quality systems | ISO |
ISO/TC 198 | Sterilization of health care products | ISO |
ISO/TC 210 | Quality management and corresponding general aspects for products with a health purpose including medical devices | ISO |
ISO/TC 212 | Medical laboratories and in vitro diagnostic systems | ISO |
Liaison Committees from ISO/TC 76
ISO/TC 76 can access the documents of the committees below:
Reference | Title | ISO/IEC |
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ISO/TC 45/SC 2 | Testing and analysis | ISO |
ISO/TC 61/SC 9 | Thermoplastic materials | ISO |
ISO/TC 63 | Glass containers | ISO |
ISO/TC 84 | Devices for administration of medicinal products and catheters | ISO |
ISO/TC 106/SC 4 | Dental instruments | ISO |
ISO/TC 150/SC 2 | Cardiovascular implants and extracorporeal systems | ISO |
ISO/TC 176/SC 2 | Quality systems | ISO |
ISO/TC 194 | Biological and clinical evaluation of medical devices | ISO |
ISO/TC 198 | Sterilization of health care products | ISO |
ISO/TC 210 | Quality management and corresponding general aspects for products with a health purpose including medical devices | ISO |
ISO/TC 212 | Medical laboratories and in vitro diagnostic systems | ISO |
ISO/TC 76 - Secretariat
DIN (Germany)
D-10787 Berlin
Germany