prBAS EN ISO 13408-1:2025
Aseptic processing of health care products - Part 1: General requirements
General information
Status:Project
Number of pages:85
Adoption method:Proglašavanje
Language:engleski
Edition:3.
Realization date:22.10.2024
Forseen date for next stage code:12.03.2025
Technical committee:BAS/TC 25, Healthcare
Directives:
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
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
ICS:
11.080.01, Sterilization and disinfection in general
Abstract
This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products.
This document includes requirements and guidance relative to the overall topic of aseptic processing.
Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.
Lifecycle
...
Original document and degree of correspondence
EN ISO 13408-1:2024, identical
ISO 13408-1:2023, identical
Relation to BAS standards
Work material
Only members of the technical committee have access to work material. If you are a members of this technical committee you need to login to view the documents. Login