Standards search
EN ISO 11607-1:2020/A1:2023

EN ISO 11607-1:2020/A1:2023

Name: EN ISO 11607-1:2020/A1:2023
Brand: CEN
SKU: EN ISO 11607-1:2020/A1:2023
Price: 48.78 EUR
Availability: InStock
Rating: 5 (72 reviews)

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1: Application of risk management (ISO 11607-1:2019/Amd 1:2023)

Publication date: Feb 19, 2024

General information

Current stage: 60.60 Standard published Oct 25, 2023

Originator: CEN

Owner: CEN/TC 102 Sterilizers and associated equipment for processing of medical devices

Type: European Norm

ICS: 11.080.30 Sterilized packaging

Buying

Status: Published

PDF - €48.78

Languages: English

Buy

Related legislation

Legislation related to this standard

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/Supporting

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/Supporting

PREVIOUSLY

PUBLISHED
EN ISO 11607-1:2020

NOW

PUBLISHED
EN ISO 11607-1:2020/A1:2023
60.60 Standard published
Oct 25, 2023

Menu