SIST 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
- 18-Apr-2018
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 06-Apr-2018
- Due Date
- 11-Jun-2018
- Completion Date
- 19-Apr-2018
Relations
- Effective Date
- 01-May-2018
- Effective Date
- 01-May-2018
Frequently Asked Questions
SIST EN ISO 13485:2016/AC:2018 is a corrigendum published by the Slovenian Institute for Standardization (SIST). 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
SIST EN ISO 13485:2016/AC:2018 is classified under the following ICS (International Classification for Standards) categories: 03.100.70 - Management systems; 11.020.01 - Quality and environmental management in health care. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 13485:2016/AC:2018 has the following relationships with other standards: It is inter standard links to SIST EN ISO 13485:2016/AC:2017, SIST EN ISO 13485:2016. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST 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 SIST 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 SIST standards.
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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The article discusses the creation of a 2nd corrigendum for SIST EN ISO 13485:2016/AC:2018. The 1st corrigendum was found to have incomplete and unclear instructions.
기사 제목 : SIST EN ISO 13485:2016/AC:2018 - 의료기기 - 품질관리시스템 - 규정상 요구사항 (ISO 13485:2016) 기사 내용 : CCMC - 1차 교정표의 지시사항이 불완전하고 불명확하여 2차 교정표를 작성하였다.
記事のタイトル：SIST EN ISO 13485:2016/AC:2018 - 医療機器 - 品質管理システム - 規制要件に関する要求事項（ISO 13485:2016） 記事の内容：CCMC - 第1の訂正箇所の指示が不完全で分かりにくかったため、第2の訂正箇所を作成しました。
記事タイトル：SIST EN ISO 13485:2016/AC:2018 - 医療機器 - 規制目的のための品質管理システム - 要件（ISO 13485:2016） 記事内容：CCMC - 1次補正案の指示が不完全で不明確であったため、第2次補正案の作成が行われます。
기사 제목: SIST EN ISO 13485:2016/AC:2018 - 의료 기기 - 규제 요건을 위한 품질 관리 시스템 (ISO 13485:2016) 기사 내용: CCMC - 1차 수정본 안내가 불완전하고 애매하다는 이유로 제 2차 수정본의 작성이 진행됩니다.
The article discusses the creation of a second corrigendum for the SIST EN ISO 13485:2016/AC:2018 standard. The first corrigendum's instructions were incomplete and unclear, leading to the need for a revised version.
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