EN ISO 13485:2003/AC:2009
(Corrigendum)Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)
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- Withdrawn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
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 15-Feb-2012
- Completion Date
- 15-Feb-2012
Relations
- Effective Date
- 04-Jul-2009
- Effective Date
- 22-Feb-2012
- Effective Date
- 08-Jun-2022
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Frequently Asked Questions
EN ISO 13485:2003/AC:2009 is a corrigendum published by the European Committee for Standardization (CEN). Its full title is "Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)". This standard covers: 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
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
EN ISO 13485:2003/AC:2009 is classified under the following ICS (International Classification for Standards) categories: 03.100.70 - Management systems; 03.120.10 - Quality management and quality assurance; 11.040.01 - Medical equipment in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 13485:2003/AC:2009 has the following relationships with other standards: It is inter standard links to EN ISO 13485:2003/AC:2007, EN ISO 13485:2012, EN ISO 13485:2003. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 13485:2003/AC:2009 is associated with the following European legislation: EU Directives/Regulations: 765/2008, 90/385/EEC, 93/42/EEC, 98/79/EC; Standardization Mandates: M/417, M/BC/CEN/89/9. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN ISO 13485:2003/AC:2009 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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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