EN ISO 13485:2012/AC:2012

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

2012-04-27 EMA: CEN/CLC Corrigendum only for the Annex ZA

Medizinprodukte - 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)

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

Standard ISO 13485 2003 določa zahteve za sisteme vodenja kakovosti v primerih, ko mora organizacija izkazati svojo zmožnost dobave medicinskih pripomočkov in povezanih storitev, ki dosledno izpolnjujejo zahteve strank ter zakonodajne zahteve, ki se uporabljajo za medicinske pripomočke in povezane storitve.  Glavni cilj standarda ISO 13485:2003 je omogočiti harmonizirane zakonodajne zahteve za medicinske pripomočke za sisteme vodenja kakovosti. Standard zato vključuje nekatere posebne zahteve za medicinske pripomočke in izključuje nekatere zahteve standarda ISO 9001, ki niso primerne kot zakonodajne zahteve. Organizacije, katerih sistemi vodenja kakovosti so skladni s tem mednarodnim standardom, se zaradi teh izključitev ne morejo sklicevati na skladnost s standardom ISO 9001, razen če so njihovi sistemi vodenja kakovosti skladni z vsemi zahtevami standarda ISO 9001. Vse zahteve standarda ISO 13485:2003 veljajo za organizacije, ki dobavljajo medicinske pripomočke, ne glede na vrsto ali velikost organizacije. Če zakonodajne zahteve omogočajo izključitve kontrol zasnove in razvoja, se lahko to uporabi kot utemeljitev za njihovo izključitev iz sistema vodenja kakovosti. Ti predpisi lahko zagotovijo nadomestne ureditve, ki se morajo obravnavati v sistemu vodenja kakovosti. Organizacija mora zagotoviti, da sklicevanje na skladnost s standardom ISO 13485:2003 odraža izključitev kontrol zasnove in razvoja. Če se katera koli zahteva v točki 7 standarda ISO 13485:2003 ne uporablja zaradi narave medicinskega pripomočka, za katerega se sistem vodenja kakovosti uporablja, organizaciji take zahteve ni treba vključiti v svoj sistem vodenja kakovosti.
Postopki, ki jih standard ISO 13485:2003 zahteva in ki se uporabljajo za medicinske pripomočke, vendar jih organizacija ne izvaja, so odgovornost organizacije in so opisani v sistemu vodenja kakovosti organizacije.

General Information

• Status: Withdrawn
• Publication Date: 03-Jul-2012
• Withdrawal Date: 01-Mar-2016
• 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
• Completion Date: 02-Mar-2016
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• 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/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 13485:2012/AC:2012 - Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)

Relations

• Replaced By: EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
• Effective Date: 09-Mar-2016
• Corrects: EN ISO 13485:2012 - 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 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



SIST EN ISO 13485:2012/AC:2012



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



EN ISO 13485:2012/AC:2012 (E) 2 1 Modification to the Title The title of EN ISO 13485:2012 has to be corrected as such: "Medical devices  Quality management systems  Requirements for regulatory purposes  Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)". 2 Modification to ZC.4, Relationship with Annex VII of Directive 98/79/EC Replace Table ZC.3 with the following one: " Paragraph of Directive 98/79/EC, Annex VII Clause(s) of EN ISO 13485 Comments/Qualifying remarks 3.1 first paragraph
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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