Standard

NS-EN ISO 13485:2000

Withdrawn

Note: This standard has a new edition: NS-EN ISO 13485:2016+AC:2018

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Abstract

This International Standard specifies, in conjunction with ISO 9001, the quality System requirements for the design/development, production and, when relevant, installation and servicing of medical devices. This International Standard, in conjunction with ISO 9001 9 is applicable when there is a need to assess a medical device supplier’s quality System. As part of an assessment by a third Party for the purpose of regulatot-y requirements, the supplier may be required to provide access to confidential data in Order to demonstrate compliance with this International Standard. The supplier may be required to exhibit these data but is not obliged to provide copies for retention. NOTE - In this International Standard the term "if appropriate" is used several times. When a requirement is qualified by this Phrase, it is deemed to be "appropriate" unless the supplier tan document a justification otherwise. A requirement is considered "appropriate" if its non-implementation could result in - the product not meeting its specified requirements, and/or - the supplier being unable to carry out corrective action.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 1
  • Version: 1
  • Document type: NAT
  • ICS 03.100.70
  • ICS 03.120.10
  • ICS 11.040.01
  • National Committee ISO/TC 210

Legal references

EU law: 90/385/EEC, 98/79/EC, 93/42/EEC

Product Relations

Product life cycle