In Table ZA.2, 13th row relating to 3.2, 3rd paragraph (b), 3rd, replace in the 2 nd column with to read: 3.2, 3rd paragraph (b), 3rd 1, 4.1, 4.2, 7.4, Covered. 2ĥ In Table ZA.1, 23th row relating to 3.2, 3rd paragraph (e), delete in the 2 nd column to read: 3.2, 3rd paragraph (e) 4.2, 7.1, 7.4.3,, 7.6, Covered provided that the documented frequency at which tests are carried out is detailed in the quality management system documentation. In Table ZA.1, 15th row relating to 3.2 3rd paragraph (b) 3rd, replace in the 2 nd column with to read: 3.2 3rd paragraph (b) 3rd 1, 4.1, 4.2, 7.4, Covered. 4 Modifications to ZA.1 In Table ZA.1, 12th row relating to 3.2, 3rd paragraph (b), replace in the 2 nd column with 5.1 to read: 3.2, 3rd paragraph (b) 4.2.2, 5.1 Covered. Delete the last sentence in NOTE 2 to read: NOTE 2 The manufacturer s policy for determining acceptable risk must be in compliance with essential requirements 1, 4, 5, 8, 9 and 10 of the Directive. In NOTE 1, 1 st sentence, replace the reference to the Directive with Directive 90/385/EEC to read: NOTE 1 Where a reference from a clause of this European Standard to the risk management process is made, the risk management process needs to be in compliance with Directive 90/385/EEC, as amended by 2007/47/EC.
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Delete the 3 rd paragraph starting with EN ISO 13485:2016 provides requirements.
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3 Modifications to ZA.0 Replace the 1 st paragraph with the following: This European Standard has been prepared under a mandate given to CEN/CENELEC by the European Union and the European Free Trade Association to provide a means by which a manufacturer may demonstrate conformity, and by which the Notified Body may assess the manufacturer s conformity, with the requirements of Directive 90/385/EEC (as amended) on active implantable medical devices. with the following: This document supersedes EN ISO 13485:2012 and CEN ISO/TR 14969: Modification to the heading of Annex ZA Replace the current heading of Annex ZA with: Relationship between this European Standard and the Conformity Assessment Requirements of EU Directive 90/385/EEC (as amended). EN ISO 13485:2016:EN ISO 13485:2016/AC:2018 EĤ 1 Modification to the European foreword Replace the current fourth paragraph This document supersedes EN ISO 13485:2012. Alle Rechte der Verwertung, gleich in welcher Form und in welchem Verfahren, sind weltweit den nationalen Mitgliedern von CEN und den Mitgliedern von CENELEC vorbehalten. Tous droits d'exploitation sous quelque forme et de quelque manière que ce soit réservés dans le monde entier aux membres nationaux du CEN et aux membres du CENELEC.
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CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members.
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3 EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO 13485:2016/AC March 2018 ICS English version Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires (ISO 13485:2016) Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016) This corrigendum becomes effective on 28 March 2018 for incorporation in the official English version of the EN.