EN ISO 13485:2003/AC:2007

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

TC - BT decision, withdrawal of EN 46003:1999 and subsequent modifications regarding Module E
20061212 - Corrects EN ISO 13485:2003 and withdraws EN 46003:1999

Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2003)

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

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

General Information

• Status: Withdrawn
• Publication Date: 26-Jun-2007
• Withdrawal Date: 25-Aug-2009
• 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: 26-Aug-2009
• Completion Date: 26-Aug-2009
• 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: SIST EN ISO 13485:2003/AC:2008 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

Relations

• Replaced By: EN ISO 13485:2003/AC:2009 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)
• Effective Date: 04-Jul-2009
• 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.Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)NRQRGDMQHDispositifs médicaux - Systèmes de manegement de la qualité - Exigences à des fins réglementaires (ISO 13485:2003)Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke
(ISO 13485:2003)Ta slovenski standard je istoveten z:EN ISO 13485:2003/AC:2007SIST EN ISO 13485:2003/AC:2008en,fr,de11.040.0103.120.10ICS:SLOVENSKI
STANDARDSIST EN ISO 13485:2003/AC:200801-april-2008

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 13485:2003/AC
June 2007
Juin 2007
Juni 2007 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)
Dispositifs médicaux - Systèmes de manegement de la qualité - Exigences à des fins réglementaires (ISO 13485:2003) Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke
(ISO 13485:2003) This corrigendum becomes effective on 27 June 2007 for incorporation in the three official language versions of the EN.
Ce corrigendum prendra effet le 27 juin 2007 pour incorporation dans les trois versions linguistiques officielles de la EN.
Die Berichtigung tritt am 27.Juni 2007 zur Einarbeitung in die drei offiziellen Sprachfassungen der EN in Kraft.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36
B-1050 Brussels © 2007 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national 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. Alle Rechte der Verwertung, gleich in welcher Form und in welchem Verfahren, sind weltweit den nationalen Mitgliedern von CEN vorbehalten. Ref. No.:EN ISO 13485:2003/AC:2007 D/E/F

2 English Version
1 Modification to the title page Add the following reference to the superseding note:
“EN 46003:1999” 2 Modification to the 2nd paragraph
Replace with the following:
"This European Standard supersedes EN 46003:1999, EN ISO 13485:2000 and EN ISO 13488:2000."
3 Modification to the 3rd paragraph
Replace "July 2006" with" July 2009"
4 Modification to the 7th paragraph
Replace the first sentence with the following:
"Three of the modules cited in Council decision, i.e. modules E, D and H require that "the manufacturer must operate an approved quality system".
Add the following first dash to the existing two:
"- Final product inspection and testing (module E),"
5 Modification to the 8th paragraph
Replace twice in the first and second sentences "modules D or H" with "modules E, D or H".
6 Modification to the 9th paragraph
To be deleted.
7 Modification to the table Replace the table with the following:
Module D Permissible exclusions Module E Permissible exclusions for conformity of "product quality assurance" Module H Permissible exclusions Sub-clause 7.3: design and development Sub-clause 7.3: design and development Sub-clause 7.5.1: control of production and service provision Sub-clause 7.5.2: validation of processes for production and service provision NO exclusions permitted Module D is the basis for annex V of 93/42/EEC Directive and the basis for annex VII of 98/79/EC Directive. Module E is the basis for annex VI of Directive 93/42/EEC. Module H is the basis for annex 2 of Directive 90/385/EEC, for annex II of Directive 93/42/EEC and for annex IV of Directive 98/79/EC.
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 Association to provide a means of conforming to Essential Requirements of the New Approach Directive 90/385/EEC.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the normative clauses of this standard confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard."

4 10 Modification to Annex ZB Replace Annex ZB with the following:
"Annex ZB (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the normative clauses of this standard confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard."
11 Addition of a new Annex ZC Add new Annex ZC:
"Annex ZC (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC
This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 98/79/EC.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the normative clauses of this standard confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard."

1 Modification apportée à la page de garde Ajouter la référence suivante à la mention de remplacement :
“EN 46003:1999”
Lire : "Remplace EN 46003:1999, EN ISO 13485:2000 et EN ISO 13488:2000"
2 Avant-propos
-
Modification apportée au 2ème paragraphe
Remplacer la phrase actuelle par la suivante :
"La présente Norme européenne annule et remplace l’EN 46003:1999, l’EN ISO 13485:2000 et l’EN ISO 13488:2000."
3 Avant-propos
-
Modification apportée au 3ème paragraphe
Remplacer "Juillet 2006" par Juillet 2009"
4 Avant-propos
-
Modification apportée au 7ème paragraphe
Remplacer la première phrase par :
"Trois des modules cités dans la décision du Conseil, c’est-à-dire les modules E, D et H, requièrent "que le fabricant mette en œuvre un système qualité approuvé".
Insérer en première position le tiret suivant :
"- Contrôles et essais finaux du produit (module E),"
5 Avant-propos
-
Modification apportée au 8tème paragraphe
Remplacer deux fois dans la première et la deuxième phrase "modules D ou H" par "modules E, D ou H".
6 Avant-propos
-
Modification apportée au 9ème paragraphe
A supprimer.
7 Avant-propos
-
Modification apportée au tableau Remplacer le tableau existant par le tableau suivant :
Module D Exclusions autorisées Module E Exclusions autorisées pour l'évaluation de la conformité de "l'assurance de la qualité du produit" Module H Exclusions autorisées Paragraphe 7.3 : Conception et développement Paragraphe 7.3 : Conception et développement Paragraphe 7.5.1 : Maîtrise de la production et de la préparation du service Paragraphe 7.5.2 : Validation des processus de production et de préparation du service Aucune exclusion autorisée Le module D est la base de l’annexe V de la Directive 93/42/CEE et la base de l’annexe VII de la Directive 98/79/CE. Le module E est la base de l’annexe VI de la Directive 93/42/CEE. Le module H est la base de l’annexe 2 de la Directive 90/385/CEE,
...