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naSRPS EN ISO 13408-2:2018/prA1:2024

Aseptic processing of health care products - Part 2: Sterilizing filtration - Amendment 1 (ISO 13408-2:2018/DAmd1:2025)

General information

40.20     Oct 23, 2025

40.60    Dec 26, 2025

ISS

Z076

European Norm

11.080.01  

English  

Buying

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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

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 13408-2:2018/prA1:2024
40.20 DIS ballot initiated: 12 weeks
Oct 23, 2025

Related project

Adopted from EN ISO 13408-2:2018/prA1:2025 IDENTICAL

Adopted from ISO 13408-2:2018/DAmd 1 IDENTICAL

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