EN
SR EN 868-5:2009
Materiale de ambalare pentru dispozitive medicale sterilizate în stadiul terminal. Partea 5: Confecţionarea pungilor şi rolelor de hârtie prin termosigilare din materiale poroase şi film de material plastic. Cerinţe şi metode de încercare
This part of EN 868 provides test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4 used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user. This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. The materials specified in this part of EN 868 are intended for single use only. NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, con
Status :
Anulat
Data aprobării : 30.10.2009
Data publicării : 01.11.2009
Data anulării : 31.05.2019
Număr de pagini : 19
ICS : 11.080.30 Ambalaje sterile
Comitet tehnic : 377 - Medicale
- Inlocuieste SR EN 868-5:2002
- Inlocuieste SR EN 868-5:2002/AC:2003
- Inlocuit prin SR EN 868-5:2019