NEN-EN 46001
Quality systems - Medical devices - Particular requirements for the application of EN 29001
inactive
| Organization: | NEN |
| Publication Date: | 1 May 1994 |
| Status: | inactive |
| ICS Code (Quality management and quality assurance): | 03.120.10 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
This European standard, together with NEN-ISO 9001, specifies the quality system requirements for the design/development, production, supply, installations and servicing of medical devices. In addition to the field of application of NEN-ISO 9001, this European standard, together with NEN-ISO 9001 is applicable when a medical device supplier's quality system is assessed in accordance with regulatory requirements.
Document History
September 1, 1996
Quality systems - Medical devices - Particular requirements for the application of EN ISO 29001
Specifies, in conjunction with EN ISO 9001, the quality system requirements for the design/development, production, and where relevant, installation and servicing of medical devices. The field of...
NEN-EN 46001
May 1, 1994
Quality systems - Medical devices - Particular requirements for the application of EN 29001
This European standard, together with NEN-ISO 9001, specifies the quality system requirements for the design/development, production, supply, installations and servicing of medical devices. In...