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naSRPS EN ISO 11137-1:2020

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023)

General information

45.99     Nov 13, 2023

50.20    Feb 19, 2024

ISS

Z076

European Norm

11.080.01     11.080.99  

English  

Related directives

Directives related to this standard.

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

Life cycle

NOW

PROJECT
naSRPS EN ISO 11137-1:2020
45.99 Dispatch of FV draft to CCMC
Nov 13, 2023

Related project

Adopted from prEN ISO 11137-1

Adopted from ISO/FDIS 11137-1 IDENTICAL