UNI EN ISO 11140-1 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
27-08-2022
01-01-2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 General requirements
6 Performance requirements
7 Test methods
8 Additional requirements for process (Class 1) indicators
9 Additional requirements for single variable (Class 3)
indicators
10 Additional requirements for multi-variable (Class 4)
indicators
11 Additional requirements for steam integrating (Class 5)
indicators
12 Additional requirements for dry heat integrating (Class 5)
indicators
13 Additional requirements for ethylene oxide integrating
(Class 5) indicators
14 Additional requirements for emulating (Class 6) indicators
Annex A (informative) - Method for demonstrating shelf life
of the product
Annex B (informative) - Examples of testing indicators
Annex C (informative) - Rationale for the requirements for
integrating indicators and the link to the requirements
for biological indicators (BIs) specified in ISO 11138
and microbial inactivation
Annex D (informative) - Rationale for the liquid-phase test
method for steam-formaldehyde indicators
Annex E (informative) - Relationship of indicator components
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC
Bibliography
Defines general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the process parameter(s) specified for a sterilization process.
| DevelopmentNote |
Supersedes UNI EN 867-1 and UNI EN 867-2. (10/2005)
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| SN EN ISO 11140-1:2015 | Identical |
| ISO 11140-1:2014 | Identical |
| BS EN ISO 11140-1:2014 | Identical |
| NBN EN ISO 11140-1 : 2014 | Identical |
| NF EN ISO 11140-1 : 2015 | Identical |
| UNE-EN ISO 11140-1:2015 | Identical |
| I.S. EN ISO 11140-1:2014 | Identical |
| NEN EN ISO 11140-1 : 2014 | Identical |
| EN ISO 11140-1:2014 | Identical |
| NS EN ISO 11140-1 : 2014 | Identical |
| DIN EN ISO 11140-1:2015-03 | Identical |
| UNI/TR 11408 : 2011 | GUIDE TO DESIGN, DEVELOPMENT AND CONTROL OF A RECONDITION PROCESS FOR REUSABLE MEDICAL DEVICES THAT SHALL BE STERILIZED BY STEAM |
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