EN ISO 13408-2:2018/prA1

Aseptic processing of health care products — Part 2: Sterilizing filtration — Amendment 1 EN ISO 13408-2:2018/prA1

General information

Current stage: 10.99 New project approved Jul 24, 2024

Originator: CEN

Owner: CEN/TC 204 Sterilization of medical devices

Type: European Norm

ICS: 11.080.01 Sterilization and disinfection in general

Related legislation

Legislation 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

Legislation 2017/745

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

Legislation 2017/746

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 13408-2:2018

NOW

IN_DEVELOPMENT
EN ISO 13408-2:2018/prA1
10.99 New project approved
Jul 24, 2024