NEN EN ISO 11140-1 : 2014

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
Bibliography
Annex ZA (informative) Relationship between this European
                       Standard and the Essential
                       Requirements of EU Directive
                       93/42 EEC
Annex ZA (normative) Normative references to international
                       publications with their relevant
                       European publications

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.