Ïã¸ÛÁùºÏ²Ê¿ª½±/TR 14969:2004 was withdrawn. Guidance for the implementation of Ïã¸ÛÁùºÏ²Ê¿ª½± 13485:2016 is provided in a Handbook entitled “Ïã¸ÛÁùºÏ²Ê¿ª½± 13485:2016 — Medical devices — A practical guide"
Abstract
Ïã¸ÛÁùºÏ²Ê¿ª½±/TR 14969:2004 provides guidance for the application of the requirements for quality management systems contained in Ïã¸ÛÁùºÏ²Ê¿ª½± 13485. It does not add to, or otherwise change, the requirements of Ïã¸ÛÁùºÏ²Ê¿ª½± 13485. It does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.
This guidance can be used to better understand the requirements of Ïã¸ÛÁùºÏ²Ê¿ª½± 13485 and to illustrate some of the variety of methods and approaches available for meeting the requirements of Ïã¸ÛÁùºÏ²Ê¿ª½± 13485.
General information
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Status: WithdrawnPublication date: 2004-10Stage: Withdrawal of International Standard [95.99]
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Edition: 1Number of pages: 74
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Technical Committee :Ïã¸ÛÁùºÏ²Ê¿ª½±/TC 210
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Life cycle
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Previously
WithdrawnÏã¸ÛÁùºÏ²Ê¿ª½± 14969:1999
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Now
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