TR 7-1:2002
Technical Reference - Quality system for medical device components - Requirements (Refer to ISO 13485:2003 and ISO/TR 14969:2004)
OVERVIEW
Sets requirements for quality system applicable to the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labelling and storage of all components which are used in finished devices intended for human use. Intended to ensure that components meet the requirements of finished medical devices manufacturer. Establishes basic requirements applicable to manufacturers of components.
COMMENTS
Users can refer to ISO 13485:2003 and ISO/TR 14969:2004
PRODUCT DETAILS
| Status | Withdrawn - 29 Jul 2009 |
|---|---|
| Edition | 2002 |
| No. of Pages | 30 |
| ICS Classification | |
| Committee | Medical Technology Standards Committee |
| Available for Purchase | unknown |
| Adoption | - |