EN ISO 13485:2012/AC:2012
(Corrigendum)Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)
General Information
- Abstract
2012-04-27 EMA: CEN/CLC Corrigendum only for the Annex ZA
- Status
- Withdrawn
- Publication Date
- 03-Jul-2012
- Withdrawal Date
- 22-Sep-2026
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 02-Mar-2016
- Completion Date
- 23-Sep-2026
Not Harmonized90/385/EEC - Active implantable medical devicesOJ Ref: C, C 262 OJ Date: 30-Aug-2012
Not Harmonized93/42/EEC - Medical devicesOJ Ref: C, C 262 OJ Date: 30-Aug-2012
Not Harmonized98/79/EC - In vitro diagnostic medical devicesOJ Ref: C, C 262 OJ Date: 30-Aug-2012
Relations
- Effective Date
- 09-Mar-2016
- Effective Date
- 08-Jun-2022
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Frequently Asked Questions
EN ISO 13485:2012/AC:2012 is a corrigendum published by the European Committee for Standardization (CEN). Its full title is "Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)". This standard covers: 2012-04-27 EMA: CEN/CLC Corrigendum only for the Annex ZA
2012-04-27 EMA: CEN/CLC Corrigendum only for the Annex ZA
EN ISO 13485:2012/AC:2012 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 13485:2012/AC:2012 has the following relationships with other standards: It is inter standard links to EN ISO 13485:2016, EN ISO 13485:2012. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 13485:2012/AC:2012 is associated with the following European legislation: EU Directives/Regulations: 2007/47/EC, 90/385/EEC, 93/42/EEC, 98/79/EC; Standardization Mandates: M/023. 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 13485:2012/AC:2012 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 management de la qualité - Exigences à des fins réglementaires - Rectificatif technique 1 (ISO 13485:2003+Cor 1:2009)Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (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 13485:2012/AC:2012SIST EN ISO 13485:2012/AC:2012en01-oktober-2012SIST EN ISO 13485:2012/AC:2012SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 13485:2012/AC
July 2012
Juillet 2012
Juli 2012 ICS 03.120.10; 11.040.01 English version Version Française Deutsche Fassung
Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1
(ISO 13485:2003+Cor 1:2009)
Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires - Rectificatif technique 1 (ISO 13485:2003+Cor 1:2009) Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2003+Cor 1:2009) This corrigendum becomes effective on 4 July 2012 for incorporation in the three official language versions of the EN.
Ce corrigendum prendra effet le 4 juillet 2012 pour incorporation dans les trois versions linguistiques officielles de la EN.
Die Berichtigung tritt am 4. Juli 2012 zur Einarbeitung in die drei offiziellen Sprachfassungen der EN in Kraft. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels © 2012 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 13485:2012:EN ISO 13485:2012/AC:2012 D/E/F SIST EN ISO 13485:2012/AC:2012
Not covered3.1 second paragraph 1st indent, reference to Annex IV, 3.1, 1st indent
Not covered3.1 second paragraph
1st indent, reference to Annex IV, 3.1, 2nd indent Not cove
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