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UNI EN ISO 11140-1 : 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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS

Superseded date

27-08-2022

Superseded by

UNI EN ISO 11140-1:2015

Published date

01-01-2009

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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Superseded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

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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