SS-EN-868-5 › Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
Document Center Inc. is an authorized dealer of SIS standards.
The following bibliographic material is provided to assist you with your purchasing decision:
The following bibliographic material is provided to assist you with your purchasing decision:
This document specifies 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. These sealable pouches and reels are 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. Other than the general requirements as specified in EN ISO 11607 1 and EN ISO 11607 2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document. The materials specified in this part of EN 868 are intended for single use only.
To find similar documents by classification:
11.080 (Sterilization and disinfection)
11.080.30 (Sterilized packaging)
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Customers who bought this document also bought:
ASTM-F88Standard Test Method for Seal Strength of Flexible Barrier Materials
UL-94
Standard for Tests for Flammability of Plastic Materials for Parts in Devices and Appliances
ASTM-D4169
Standard Practice for Performance Testing of Shipping Containers and Systems
Designation Name
SS-EN 868-5:2019
Revision Level
2019 EDITION
Status
Current
Publication Date
Jan. 7, 2019
Language(s)
English
Page Count
32
International Equivalent
EN 868-5:2018(IDT)