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CEN

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
ICS
03.100.70 - Management systems
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
6060 - Definitive text made available (DAV) - Publishing
Start Date
28-Mar-2018
Completion Date
28-Mar-2018
Directive
2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
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
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
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 13485:2016/AC:2018 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Relations

Replaces
EN ISO 13485:2016/AC:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Effective Date
11-Apr-2018
Corrects
EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Effective Date
08-Jun-2022
EN ISO 13485:2016/AC:2018EN ISO 13485:2016/AC:2018
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Corrigendum
EN ISO 13485:2016/AC:2018
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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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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.

You can purchase EN ISO 13485:2016/AC:2018 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.

記事のタイトル: EN ISO 13485:2016/AC:2018 - 医療機器 - 品質管理システム - 規制目的の要件（ISO 13485:2016） 記事内容: CCMC - 1次の訂正が不完全で不明瞭だったため、2次の訂正が作成される この記事では、EN ISO 13485:2016/AC:2018規格の2次の訂正について述べられています。1次の訂正では不完全で不明瞭な指示があったため、この問題に対処するために2次の訂正が作成されています。

記事のタイトル：EN ISO 13485:2016/AC:2018 - 医療機器 - 規制上の目的のための品質管理システム - 要件 (ISO 13485:2016) 記事内容：CCMC - 第1の訂正案の指示が不完全かつ不明瞭であったため、第2の訂正案の作成を行った。 この記事では、医療機器の品質管理システムに関する標準であるEN ISO 13485:2016/AC:2018の第2の訂正案の作成について取り上げています。第1の訂正案には不完全で不明瞭な指示があったため、第2の訂正案が作成されました。

The article discusses the creation of a 2nd corrigendum for the EN ISO 13485:2016/AC:2018 standard. The 1st corrigendum had incomplete and unclear instructions, and therefore a 2nd corrigendum is being created to address these issues.

기사 제목: EN ISO 13485:2016/AC:2018 - 의료기기 - 규제 목적을 위한 품질 관리 시스템 - 요구 사항 (ISO 13485:2016) 기사 내용: CCMC - 1차 교정본의 지침이 불완전하고 명확하지 않아 2차 교정본을 작성함. 기사에서는 의료기기의 품질 관리 시스템을 위한 표준인 EN ISO 13485:2016/AC:2018에 대한 2차 교정본의 작성에 대해 논의하고 있다. 첫 번째 교정본에는 불완전하고 명확하지 않은 지침이 있었기 때문에 두 번째 교정본이 작성되었다.

기사 제목: EN ISO 13485:2016/AC:2018 - 의료기기 - 품질관리시스템 - 규정 요구사항(ISO 13485:2016) 기사 내용: CCMC - 1차 교정표의 지시사항이 불완전하고 분명하지 않아 2차 교정표 작성 본 기사는 EN ISO 13485:2016/AC:2018 표준의 2차 교정표 작성에 관한 내용을 다루고 있습니다. 1차 교정표에는 불완전하고 분명하지 않은 지시사항이 있었기 때문에, 이러한 문제를 해결하기 위해 2차 교정표가 작성되고 있습니다.

The article discusses the creation of a second corrigendum for EN ISO 13485:2016/AC:2018, which is a standard for quality management systems for medical devices. The first corrigendum had incomplete and unclear instructions, so a second one was made to address these issues.

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