UNI EN ISO 11140-1 : 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.