BS EN 868-7:2009 Packaging for terminally sterilized medical devices. Adhesive coated paper for low temperature sterilization processes. Requirements and test methods
BS EN 868 Part 7 of this 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.
This part of the series of EN 868 provides examples of particular requirements and test methods for heat sealable adhesive coated paper manufactured from paper complying with EN 868-6, for use as packaging of medical devices which are to be terminally sterilized with ethylene oxide or irradiation.
It introduces no additional requirements to the general requirements of Part 1 but provides guidance based upon various elements of former, relevant national standards.
As such, the particular requirements included can be used to demonstrate compliance with one or more but not all of the requirements of BS EN 868 Part 1.
Contents of BS EN 686 contain:
- Introduction
- Scope
- Normative references
- Definitions
- Requirements
- Method for the determination of water repellency
- Method for the determination of pore size
- Method for the determination of regularity of heat seal adhesive coatings on paper
- Method for the determination of mass per unit area of uncoated paper and adhesive coating
- Method for the determination of seal strength of adhesive coating
- Dimensions and tolerances
- Bibliography