About
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Secretariat: ANSI (United States)
Committee Manager: -
Chairperson (until end 2025):Mr Scott A. Colburn
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ISO Technical Programme Manager [TPM]:ISO Editorial Manager [EM]:
- Creation date: 1994
Scope
Standardization of requirements and guidance in the field of quality management and corresponding general aspects, for products with a health purpose, including connectors for liquid and gases.
Excluded:
- generic quality management standards dealt with by ISO / TC 176;
- quality management standards for pharmaceutical products and healthcare services;
Note: Products with a health purpose include products for use in relation to health, including medical devices, adjacent products [or could also say accessories] and those with a risk profile similar to medical devices.
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This committee contributes with 11 standards to the following Sustainable Development Goals:
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ISO/TC 210 - Secretariat
ANSI (United States)
Association for the Advancement of Medical Instrumentation
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United States
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United States
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