Quality management and corresponding general aspects for medical devices
Scope LV
Not set
Scope EN
<html> <head></head> <body> <p>Standardization of requirements and guidance in the field of quality management and corresponding general aspects for medical devices. Standards for small bore connectors.</p> <p>Excluded:</p> <ul> <li>generic quality management standards dealt with by ISO / TC 176;</li> <li>quality management standards for pharmaceutical products;</li> <li>technical requirements for specific types of medical devices (Note: Small bore connectors are components of a range of medical devices but are not themselves medical devices).</li> </UL> <p><i>Note:</i></p> <p>In order to promote global harmonization the technical committee may also develop standards on general aspects stemming from the application of quality principles to medical devices, where these are not covered by the scope of another technical committee.</p> </body> </html>