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.
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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
Describes guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation and routine monitoring and overall control of sterilization processes.
| DocumentType |
Standard
|
| Pages |
44
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| BS EN ISO 15882:2008 | Identical |
| ISO 15882:2008 | Identical |
| NS EN ISO 15882 : 2ED 2008 | Identical |
| NBN EN ISO 15882 : 2008 | Identical |
| EN ISO 15882:2008 | Identical |
| NF EN ISO 15882 : 2010 | Identical |
| SN EN ISO 15882:2008 | Identical |
| UNE-EN ISO 15882:2009 | Identical |
| NEN EN ISO 15882 : 2008 | Identical |
| UNI EN ISO 15882 : 2009 | Identical |
| DIN EN ISO 15882:2008-12 | Identical |
| ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 5636-3:2013 | Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method |
| ISO 11138-3:2017 | Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| AAMI ST46 : 4ED 2002 | STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES |
| ISO 11140-3:2007 | Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test |
| EN 14180:2014 | Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
| ISO 11138-2:2017 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
| ISO 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 11140-1:2014 | Sterilization of health care products Chemical indicators Part 1: General requirements |
| ISO 18472:2006 | Sterilization of health care products Biological and chemical indicators Test equipment |
| ISO 5636-5:2013 | Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method |
| ISO 11140-4:2007 | Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| ISO 20857:2010 | Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| EN 15424:2007 | Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 11140-5:2007 | Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests |
| ISO/TS 11135-2:2008 | Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
| ISO 11138-5:2017 | Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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