Back

EVS-EN ISO 13485:2016/A11:2021

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

General information
Valid from 16.09.2021
Base Documents
EN ISO 13485:2016/A11:2021

Standard history

Status
Date
Type
Name
16.09.2021
Amendment
16.09.2021
Main + amendment
02.03.2016
Main + corrigendum
EN ISO 13485:2016/A11:2021 modifies the European standard EVS-EN ISO 13485:2016.

EVS-EN ISO 13485 specifies requirements of a quality management system for medical devices. The main text and the consolidated version which consists of main text and the amendment can be found from the standard’s history.

EVS-EN ISO 13485:2016/A11:2021 supports the requirements of EU Regulations. The relationship with EU Regulations can be found in informative annexes.

In this amendment you can find:

— Annex ZA which covers the relationship between EVS-EN ISO 13485 and the and the requirements of Regulation (EU) 2017/745.

— Annex ZB which covers the relationship between EVS-EN ISO 13485 and the requirements of Regulation (EU) 2017/746.
*
*
*
PDF
24.40 € incl tax
Paper
24.40 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

EVS-EN ISO 15223-1:2021

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
Newest version Valid from 01.10.2021
Amendment

EVS-EN ISO 14971:2019/A11:2021

Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Valid from 15.12.2021
Main

EVS-EN ISO 20417:2021

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
Newest version Valid from 17.05.2021
Main + amendment

EVS-EN 62366-1:2015+A1:2020

Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + IEC 62366-1:2015/A1:2020)
Newest version Valid from 17.08.2020