Phone: (011) 7541-421, 3409-301, 3409-335, 6547-293, 3409-310
E-mail: Standards sales: prodaja@iss.rs Education: iss-edukacija@iss.rs Information about standards: infocentar@iss.rs
Stevana Brakusa 2, 11030 Beograd
Main menu

SRPS EN ISO 13485:2017/A11:2022

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

Dec 30, 2022
Sep 30, 2024

General information

60.60     Dec 30, 2022

ISS

Z076

European Norm

11.040.01     03.100.70  

English   Serbian  

Buying

Published

Language in which you want to receive the document.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

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

Harmonized
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

Harmonized

Life cycle

NOW

PUBLISHED
SRPS EN ISO 13485:2017/A11:2022
60.60 Standard published
Dec 30, 2022

Related project

Adopted from EN ISO 13485:2016/A11:2021