Name: UNI EN 868-8 : 2009
Brand: UNI

UNI EN 868-8 : 2009

Superseded

PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS

Superseded date

05-09-2019

Published date

01-01-2009

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Information to be supplied by the manufacturer
6 Test methods
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) Handle strength test
Annex D (normative) Stacking test
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
Bibliography

Supplies 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.

DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN 868-8 : 2019
Supersedes	UNI EN 868-8 : 2002

Standards	Relationship
I.S. EN 868-8:2009	Identical
ONORM EN 868-8 : 2009	Identical
SN EN 868-8 : 2009	Identical
BS EN 868-8:2009	Identical
NBN EN 868-8 : 2009	Identical
NF EN 868-8 : 2009	Identical
NS EN 868-8 : 2009	Identical
UNE-EN 868-8:2009	Identical
NEN EN 868-8 : 2009	Identical
EN 868-8:2018	Identical
DIN EN 868-8:2009-09	Identical
EN 868-8:2009	Identical

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)
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