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SN EN ISO 15882:2008

Current
Current

The latest, up-to-date edition.

STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
Available format(s)

Hardcopy

Language(s)

German - English

Published date

12-01-2008

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Classes of chemical indicators
   5.1 General
   5.2 Class 1: Process indicators
   5.3 Class 2: Indicators for use in specific
                tests
   5.4 Class 3: Single-parameter indicators
   5.5 Class 4: Multi-parameter indicators
   5.6 Class 5: Integrating indicators
   5.7 Class 6: Emulating indicators
6 Selection of chemical indicators
7 Use of chemical indicators
   7.1 External chemical indicators
   7.2 Internal chemical indicators
   7.3 Indicators for specific test procedures
   7.4 Indicators for use with process challenge
       devices
8 Interpretation of chemical indicators
   8.1 General
   8.2 Chemical indicator responses
   8.3 Chemical indicators showing "Fail" response
9 Chemical indicators in sterility assurance
   procedures
   9.1 General
   9.2 Record keeping
10 Labelling of chemical indicators
11 Personnel training
12 Storage and handling
Annex A (informative) Background information on the
        Bowie-Dick test
Bibliography

Defines guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation, and routine monitoring and control of sterilization processes.

Committee
INB/NK 171
DocumentType
Standard
Pages
0
PublisherName
Swiss Standards
Status
Current

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