SIST EN ISO 13485:2016/AC:2018

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

CCMC - creation of a 2nd corrigendum as the instructions in the 1st corrigendum were incomplete and unclear

Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016)

Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires (ISO 13485:2016)

Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne namene (ISO 13485:2016) - Popravek AC

General Information

• Status: Published
• Publication Date: 18-Apr-2018
• ICS: 03.100.70 - Management systems
• ICS: 11.020.01 - Quality and environmental management in health care
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 06-Apr-2018
• Due Date: 11-Jun-2018
• Completion Date: 19-Apr-2018
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: EN ISO 13485:2016/AC:2018 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Relations

• Corrects: SIST EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
• Effective Date: 01-May-2018
• Replaces: SIST EN ISO 13485:2016/AC:2017 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
• Effective Date: 01-May-2018
• Corrects: SIST EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.NRQRGDMQHMedizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016)Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires (ISO 13485:2016)Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)11.020.01Vodenje kakovosti in ravnanje z okoljem v zdravstvuQuality and environmental management in health care03.100.70Sistemi vodenjaManagement systemsICS:Ta slovenski standard je istoveten z:EN ISO 13485:2016/AC:2018SIST EN ISO 13485:2016/AC:2018en01-maj-2018SIST EN ISO 13485:2016/AC:2018SLOVENSKI
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SIST EN ISO 13485:2016/AC:2018



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 13485:2016/AC
March 2018
ICS 03.100.70; 11.040.01 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.
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. 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. 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. Ref. No. EN ISO 13485:2016:EN ISO 13485:2016/AC:2018 E
SIST EN ISO 13485:2016/AC:2018



EN ISO 13485:2016/AC:2018 (E) 2 1 Modification to the European foreword Replace the current fourth paragraph "This document supersedes EN ISO 13485:2012." with the following: "This document supersedes EN ISO 13485:2012 and CEN ISO/TR 14969:2005." 2 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)". 3 Modifications to ZA.0 Replace the 1st 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." Delete the 3rd paragraph starting with "EN ISO 13485:2016 provides requirements…". In NOTE 1, 1st 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." 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." 4 Modifications to ZA.1 In Table ZA.1, 12th row relating to 3.2, 3rd paragraph (b), replace in the 2nd column "5.1.1" with "5.1" to read: " 3.2, 3rd paragraph (b) 4.2.2, 5.1 Covered. " In Table ZA.1, 15th row relating to 3.2 3rd paragraph (b) 3rd indent, replace in the 2nd column "8.5.1" with "8.2.2" to read: " 3.2 3rd paragraph (b) 3rd indent 1, 4.1, 4.2, 7.4, 8.2.2 Covered. " SIST EN ISO 13485:2016/AC:2018



EN ISO 13485:2016/AC:2018 (E) 3 In Table ZA.1, 23th row relating to 3.2, 3rd paragraph (e), delete in the 2nd column "7.5.1" to read: " 3.2, 3rd paragraph (e) 4.2, 7.1, 7.4.3, 7.5.9.1, 7.6, 8.2.6 Covered provided that the documented frequency at which tests are carried out is detailed in the quality management system documentation. " In Table ZA.2, 13th row relating to 3.2, 3rd paragraph (b), 3rd indent, replace in the 2nd column "8.5.1" with "8.2.2" to read: " 3.2, 3rd paragraph (b), 3rd indent 1, 4.1, 4.2, 7.4, 8.2.2 Covered. " In Table ZA.2, 15th row relating to 3.2, 3rd paragraph (c), 2nd indent, replace in the 2nd column "7.5.3" with "7.5.8, 7.5.9" to read: " 3.2, 3rd paragraph (c), 2nd indent 4.2, 7.5.8, 7.5.9 Covered. " Last paragraph, replace the existing text of WARNING 1 and WARNING 2 with the following: "WARNING: The preceding text and tables are specifically intended for organizations that need to comply with the European Directive 90/385/EEC in order to affix CE marking on their products and for other parties involved in that process. Other Directives might also be applicable and require a CE marking." 5 Modification to the heading of Annex ZB Replace the current heading of Annex ZB with: "Relationship between this European Standard and the Conformity Assessment Requirements of EU Directive 93/42/EEC (as amended)" 6 Modifications to ZB.0 Replace the 1st 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 93/42/EEC (as amended) on medical devices." Delete the 3rd paragraph starting with "EN ISO 13485:2016 provides requirements…". 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, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive." SIST EN ISO 13485:2016/AC:2018



EN ISO 13485:2016/AC:2018 (E) 4 7 Modifications to ZB.1 In Table ZB.1, 14th row relating to 3.2, 3rd paragraph (b), 2nd indent, replace in the 2nd column "8.2.2" with "8.2.4" to read: " 3.2, 3rd paragraph (b), 2nd indent 4.1, 5.6, 7.1, 8.2.4, 8.3, 8.4, 8.5.2, 8.5.3 Covered provided that the methods and acceptance criteria chosen by the manufacturer ensure that the requirements of the Directive are fulfilled. " In Table ZB.1, 15th row relating to 3.2, 3rd paragraph (b), 3rd indent, replace in the 2nd column "8.5.1" with "8.2.2" to read: " 3.2, 3rd paragraph (b), 3rd indent 1, 4.1, 4.2, 7.4, 8.2.2 Covered. " In Table ZB.1, replace the 27th row relating to 3.2, 3rd paragraph (d) with: " 3.2, 3rd paragraph (d) 4.2, 7.1, 7.5, 7.6, 8.1, 8.2.5, 8.2.6 Covered. " In Table ZB.1, 32th row relating to 3.2, 3rd paragraph (e), delete in the 2nd column "7.5.1" and replace "8.2.4" with "8.2.6" to read: " 3.2, 3rd paragraph (e) 4.2, 7.1, 7.4.3, 7.5.9.1, 7.6, 8.2.6 Covered provided that the documented frequency at which tests are carried out is detailed in the quality management system documentation. " In Table ZB.2, 15th row relating to 3.2 3rd paragraph (b) 2nd indent, replace in the 2nd column "8.2.2" with "8.2.4" to read: " 3.2 3rd paragraph (b) 2nd indent 4.1, 5.6, 7.1, 8.2.4, 8.3, 8.4, 8.5.2, 8.5.3 Covered provided that the methods and acceptance criteria chosen by the manufacturer ensure that the requirements of the Directive are fulfilled. " In Table ZB.2, 16th row relating to 3.2 3rd paragraph (b) 3rd indent, replace in the 2nd column "8.5.1" with "8.2.2" to read: " 3.2 3rd paragraph (b) 3rd indent 1, 4.1, 4.2, 7.4, 8.2.2 Covered. " SIST EN ISO 13485:2016/AC:2018



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