EN ISO 13485:2016/AC:2018
(Corrigendum)Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
CCMC - creation of a 2nd corrigendum as the instructions in the 1st corrigendum were incomplete and unclear
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016)
Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires (ISO 13485:2016)
Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne namene (ISO 13485:2016) - Popravek AC
General Information
- Status
- Published
- Publication Date
- 27-Mar-2018
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 28-Mar-2018
- Completion Date
- 28-Mar-2018
Relations
- Effective Date
- 11-Apr-2018
- Effective Date
- 08-Jun-2022
Frequently Asked Questions
EN ISO 13485:2016/AC:2018 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 13485:2016)". This standard covers: CCMC - creation of a 2nd corrigendum as the instructions in the 1st corrigendum were incomplete and unclear
CCMC - creation of a 2nd corrigendum as the instructions in the 1st corrigendum were incomplete and unclear
EN ISO 13485:2016/AC:2018 is classified under the following ICS (International Classification for Standards) categories: 03.100.70 - Management systems; 11.040.01 - Medical equipment in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 13485:2016/AC:2018 has the following relationships with other standards: It is inter standard links to EN ISO 13485:2016/AC:2016, EN ISO 13485:2016. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 13485:2016/AC:2018 is associated with the following European legislation: EU Directives/Regulations: 2017/745, 2017/746, 90/385/EEC, 93/42/EEC, 98/79/EC; Standardization Mandates: 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 13485:2016/AC:2018 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 13485:2016)Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires (ISO 13485:2016)Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)11.020.01Vodenje kakovosti in ravnanje z okoljem v zdravstvuQuality and environmental management in health care03.100.70Sistemi vodenjaManagement systemsICS:Ta slovenski standard je istoveten z:EN ISO 13485:2016/AC:2018SIST EN ISO 13485:2016/AC:2018en01-maj-2018SIST EN ISO 13485:2016/AC:2018SLOVENSKI
STANDARDSIST EN ISO 13485:2016/AC:20171DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 13485:2016/AC
March 2018
ICS 03.100.70; 11.040.01 English version
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires (ISO 13485:2016)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016) This corrigendum becomes effective on 28 March 2018 for incorporation in the official English version of the EN.
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels © 2018 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 13485:2016:EN ISO 13485:2016/AC:2018 E
EN
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