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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 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.<ref>[http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html
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.<ref>[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]</ref> {{fact|date=12 April 2010}}
Summary list of titles and references of harmonised standards related to medical devices - DG Enterprise & Industry. European Commission]</ref> {{fact|date=12 April 2010}}


Revision as of 02:49, 12 April 2010

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] [citation needed]

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]
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