SIST EN ISO 13485:2016/A11:2021
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 27
- Дата публикации:
- 17 ноября 2021 г.
- ICS:
- 03.100.70
- Технический комитет:
- VAZ - Healthcare
Abstract
Overview
EN ISO 13485:2016/A11:2021 is the European amendment (A11) to the international standard ISO 13485:2016 specifying quality management system (QMS) requirements for medical devices. Prepared by CEN/CLC/TC 3 and approved by CEN (12 April 2021, published September 2021), this amendment revises the European foreword and adds informative Annexes and to clarify the relationship between EN and the EU medical device regulations (MDR 2017/745 and IVDR 2017/746). When cited in the Official Journal, compliance with relevant normative clauses provides a presumption of conformity for regulatory purposes within the limits of the standard’s scope.
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