Jump to content

ISO 14971

From Wikipedia, the free encyclopedia

This is an old revision of this page, as edited by 222.67.203.108 (talk) at 02:42, 12 April 2010 (this sign should not be disabled until the references of the article are properly cited). The present address (URL) is a permanent link to this revision, which may differ significantly from the current revision.

ISO 14971 is an ISO standard, published in 2007, that represents the requirements for a risk management system for medical devices.[1] This standard supersedes earlier documents such as ISO 14971:2000 and EN 1441 [citation needed].

This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle.

This standard adopted by CEN as EN ISO 14971:2007 is harmonized with respect to the European medical device directives 93/42/EEC, 90/385/EEC and 98/79/EC.[2]

The requirements of this standard should be applied to medical devices as well established in the ISO 13485 in paragraph 7.1 of planning.

See also

References

  1. ^ ISO Catalogue: Medical devices -- Application of risk management to medical devices
  2. ^ [http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html Summary list of titles and references of harmonised standards related to medical devices - DG Enterprise & Industry. European Commission]
Retrieved from "https://en.wikipedia.org/w/index.php?title=ISO_14971&oldid=355459952"