Modifications to the title and scope statement for ISO/TC 210 have now gone into effect.
The ISO Technical Management Board has recently approved a modified title and scope statement for ISO/TC 210, which is now in effect. The new title of the technical committee is Quality management and corresponding general aspects for products with a health purpose including medical devices.
The modified scope is:
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.