BS EN 868-5:2009 Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous and plastic film construction. Requirements and test methods
Part 1 of the BS EN 868 series of European standards specifies general requirements and test methods for all packaging materials and systems intended for use as packaging for medical devices which are to be terminally sterilized in their packaging.
BS EN 868-5 provides examples of particular requirements and test methods for heat and self-sealable pouches and reels manufactured from paper complying with EN 868-3 and plastic film complying with clause 4 of this European standard.
It introduces no additional requirements to the general requirements of Part 1 of BS EN 868, but provides guidance based upon various elements of former, relevant national standards.
As such, the particular requirements given in BS EN 868-5 can be used to demonstrate compliance with one or more but not all of the requirements of Part 1 of BS EN 868.
Heat and self-sealable pouches and reels specified in this standard are suitable for use as packaging of medical devices which are to be terminally sterilized. The use of heat and self-sealable pouches and reels as primary packages enables ease of aseptic presentation where it is important for the user to be able to see the contents of the pack before it is opened.
Contents of BS EN 868-5 contain:
- Introduction
- Scope
- Normative references
- Definitions
- Requirements
- Method for the determination of resistance to the sterilization process
- Method for the determination of pinholes in plastic laminate
- Method for the determination of peel characteristics of paper/plastic laminate products
- Method for the determination of the strength of the heat seal joint for pouches and reel material
- Method for the determination of fibre orientation 8
- Dimensions and tolerances
- Bibliography