Customer Support: +44 (0)203 327 3140

Login to i2i Subscription Intertek.com
  • There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Go to AMERICAS site
Dismiss alert
Please enter a keyword to search
Advanced search

PREN 868-8 : DRAFT 2017

Current
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
Published date

22-08-2017

Publisher

Comite Europeen de Normalisation

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 European Standard 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 useful life with respect tO sterilization
Bibliography

Describes test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.

Committee
TC 102
DocumentType
Draft
PublisherName
Comite Europeen de Normalisation
Status
Current

Standards Relationship
17/30360915 DC : 0 Identical
17/30360915 DC : DRAFT AUG 2017 Identical
07/30167330 DC : DRAFT AUG 2007 Identical

BS EN 868-1:1997 Packaging materials and systems for medical devices which are to be sterilized General requirements and test methods

ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
ISO 4017:2014 Fasteners Hexagon head screws Product grades A and B
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 4582:2017 Plastics — Determination of changes in colour and variations in properties after exposure to glass-filtered solar radiation, natural weathering or laboratory radiation sources
EN ISO 4017:2014 Fasteners - Hexagon head screws - Product grades A and B (ISO 4017:2014)
PREN ISO 17664 : DRAFT 2001 STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE REPROCESSING OF RESTERILIZABLE DEVICES
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
EN 10088-1:2014 Stainless steels - Part 1: List of stainless steels

View more information
Sorry this product is not available in your region.

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.

Learn more on subscription solutions

or

Get in touch with us