EN ISO 13485:2003/AC:2009

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)

2011-09-22 SJ: M/417 & 765/2008 removed folloing request from GM (letter  ref ENTR/C1/ZB/nt ARES.c1(2011)1048723 of 2011-09-13 on follow up of mandate M/417 signed by L. Brykman).
2011-03-15 SJ: Removed OJ flag for 765/2008 (citation in light of M/417) following request from G. Malcorps.
ISO - Taking over of an ISO Techncial Corrigendum

Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2003/Cor 1:2009)

Dispositifs médicaux - Systèmes de manegement de la qualité - Exigences à des fins réglementaires (ISO 13485:2003/Cor 1:2009)

Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne namene (ISO 13485:2003/Cor 1:2009)

General Information

• Status: Withdrawn
• Publication Date: 25-Aug-2009
• Withdrawal Date: 14-Feb-2012
• ICS: 03.100.70 - Management systems
• ICS: 03.120.10 - Quality management and quality assurance
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Feb-2012
• Completion Date: 15-Feb-2012
• Directive: 765/2008 - REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93
• 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/417 - Standardisation mandate addessed to CEN, CENELEC, and ETSI for the use of Harmonised Standards in support of the new legal framework and sectoral certification schemes
• 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: SIST EN ISO 13485:2003/AC:2009 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)

Relations

• Replaces: EN ISO 13485:2003/AC:2007 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
• Effective Date: 04-Jul-2009
• Replaced By: EN ISO 13485:2012 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
• Effective Date: 22-Feb-2012
• Corrects: EN ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
• 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 13485:2003/Cor 1:2009)Dispositifs médicaux - Systèmes de manegement de la qualité - Exigences à des fins réglementaires (ISO 13485:2003/Cor 1:2009)Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)11.040.01Medicinska oprema na splošnoMedical equipment in general03.120.10Vodenje in zagotavljanje kakovostiQuality management and quality assuranceICS:Ta slovenski standard je istoveten z:EN ISO 13485:2003/AC:2009SIST EN ISO 13485:2003/AC:2009en,fr,de01-december-2009SIST EN ISO 13485:2003/AC:2009SLOVENSKI
STANDARDSIST EN ISO 13485:2003/AC:20081DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 13485:2003/AC
August 2009
Août 2009
August 2009 ICS 03.120.10; 11.040.01 English version Version Française Deutsche Fassung
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)
Dispositifs médicaux - Systèmes de manegement de la qualité - Exigences à des fins réglementaires (ISO 13485:2003/Cor 1:2009)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke
(ISO 13485:2003/Cor 1:2009) This corrigendum becomes effective on 26 August 2009 for incorporation in the three official language versions of the EN.
Ce corrigendum prendra effet le 26 août 2009 pour incorporation dans les trois versions linguistiques officielles de la EN.
Die Berichtigung tritt am 26. August 2009 zur Einarbeitung in die drei offiziellen Sprachfassungen der EN in Kraft. CEN Management Centre: CENELEC Central Secretariat:Avenue Marnix 17, B-1000 Brüssel Avenue Marnix 17, B-1000 Brüssel© 2009 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 13485:2003/AC:2009 D/E/F SIST EN ISO 13485:2003/AC:2009

Module D Permissible exclusions Module E Permissible exclusions for conformity of "product quality assurance" Module H Permissible exclusions SIST EN ISO 13485:2003/AC:2009

8 Modification to the endorsement notice Delete the note. 9 Modification to Annex ZA Replace Annex ZA with the following:
"Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Associati
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