SR EN 46001:2000

Quality systems. Medical devices. Particular requirements for the application of EN ISO 9001

This European Standard 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 application of EN ISO 9001 applies. In addition, this European Standard, in conjunction with EN ISO 9001, is applicable when a medical device supplier's quality system is assessed in accordance with regulatory requirements. As part of an assessment by a third party for the purpose of regulatory requirements, the supplier may be required to provide access to confidential data in order to demonstrate compliance with this standard. The supplier may be required to exhibit these data but is not obliged to provide copies for retention.

General information

Status : Withdrawn
Approval date : 2/3/2000
Publish date : 2/4/2000
Withdrawal date : 11/20/2003
Number of pages : 18
ICS : 03.120.10 Quality management and quality assurance,11.040.01 Medical equipmet in general
Technical Committee : 377 - Medical devices

Relations with other standards:

Normative reference SR EN ISO 9001:1995
Normative reference SR ISO 8402:1995
Replaced by SR EN ISO 13485:2003