I.S. EN 868-8:2018
Current
The latest, up-to-date edition.
Packaging for terminally sterilized medical devices – Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
Hardcopy , PDF
English
25-01-2019
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Information to be supplied by the manufacturer
Annex A (informative) Details of significant technical changes between this document and the previous edition
Annex B (informative) Guidance on dimensions
Annex C (normative) Carrying device strength test
Annex D (normative) Stacking test - Procedure
Annex E (normative) Stacking device capability test
Annex F (normative) Determination of sterilization performance
Annex G (normative) Load dryness tests
Annex H (informative) Guidance on determination of service life with respect to sterilization
Bibliography
Important note : All end users must be registered with an Account prior to user licenses being assigned.Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.