NEN-EN 46003
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003
inactive, Most Current
| Organization: | NEN |
| Publication Date: | 1 September 1999 |
| Status: | inactive |
| Page Count: | 13 |
| ICS Code (Product and company certification. Conformity assessment): | 03.120.20 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
Specifies, in conjunction with EN ISO 9003:1994, the quality system requirements for the final inspection and test of medical devices excluding in vitro diagnostic medical devices and active implantable medical devices, and is applicable when a medical device supplier's quality system is assessed in accordance with regulatory requirements.
Document History
NEN-EN 46003
September 1, 1999
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003
Specifies, in conjunction with EN ISO 9003:1994, the quality system requirements for the final inspection and test of medical devices excluding in vitro diagnostic medical devices and active...
May 1, 1996
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003
Specifies, in conjunction with EN ISO 9003:1994, the quality system requirements for the final inspection and test of medical devices excluding in vitro diagnostic medical devices and active...