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ISO 13485 (1st Edition). 2000: EN ISO 13485 is published by CEN, creating a European Norm version of the international standard, and the previous European standard (EN 46001) is withdrawn. 2003: ISO 13485 (2nd Edition). 2012: EN ISO 13485 is revised so that it harmonizes with the three European directives associated with the medical sector: 93 ...
Design History File (DHF) The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.
ISO 13485:2012. Add languages. Add links ... Upload file; Special pages ... Get shortened URL; Download QR code; Print/export Download as PDF; Printable version ...
ISO 13473-1:1997 Part 1: Determination of Mean Profile Depth; ISO 13473-2:2002 Part 2: Terminology and basic requirements related to pavement texture profile analysis; ISO 13473-3:2002 Part 3: Specification and classification of profilometers; ISO/TS 13473-4:2008 Part 4: Spectral analysis of surface profiles
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It is critical that the most current version of a published standard be used or referenced. The originator or standard writing body often has the current versions listed on its web site. In social sciences , including economics , a standard is useful if it is a solution to a coordination problem : it emerges from situations in which all parties ...
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