Customer Support: +1 416-401-8730

Login to i2i Subscription Intertek.com
  • There are no items in your cart
Please enter a keyword to search
Advanced search

I.S. EN 868-8:2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Hardcopy , PDF

Superseded date

01-25-2019

Language(s)

English

Published date

01-01-2009

Publisher

National Standards Authority of Ireland

Preview

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.

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

Gives 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
Pages
21
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
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
SN EN 868-8 : 2009 Identical
DIN EN 868-8:2009-09 Identical
UNI EN 868-8 : 2009 Identical
ONORM EN 868-8 : 2009 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

View more information
US$58.10
Excluding Tax where applicable
USD
CAD
CHF
CNY
DKK
EUR
GBP
HKD
IDR
INR
JPY
KRW
MXN
NOK
NZD
SEK
SGD
USD
ZAR
Hardcopy - English
PDF - English
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50

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