I.S. EN ISO 15882:2008
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
Hardcopy , PDF
English
01-01-2008
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Introduction
1 Scope
2 Terms and definitions
3 General considerations
4 Classes of chemical indicator
4.1 General
4.2 Class 1: Process indicators
4.3 Class 2: Indicators for use in specific tests
4.4 Class 3: Single variable indicators
4.5 Class 4: Multi-variable indicators
4.6 Class 5: Integrating indicators
4.7 Class 6: Emulating indicators
5 Selection of chemical indicators
6 Use of chemical indicators
6.1 Class 1 process indicators
6.2 Class 2 indicators
6.3 Class 3, 4, 5 and 6 indicators
6.4 Indicators for use with process challenge devices
7 Interpretation of results from chemical indicators
7.1 General
7.2 Chemical indicator responses
7.3 Chemical indicators showing "fail" response
8 Chemical indicators in sterility assurance procedures
8.1 General
8.2 Record keeping
9 Personnel training
10 Storage and handling
11 Labelling
11.1 General
11.2 Indicator marking
11.3 Process marking
11.4 Package marking
Annex A (informative) - Background on the Bowie and Dick test
Annex B (informative) - Explanation of the terms "parameter"
and "variable"
Annex C (informative) - Rationale for the requirements for
integrating indicators and the link to requirements
for biological indicators (BIs) specified in the
ISO 11138 series and microbial inactivation (derived
from ISO 11140-1)
Annex D (informative) - Specifications for porosity
Annex E (informative) - Figure showing relationship of indicator
components
Bibliography
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