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 (ISO 15882:2008)
01-09-2008
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
ISO 15882:2008 provides 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.ISO 15882:2008 applies to indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor one or more of the variables required for a sterilization process. These chemical indicators are not dependent for their action on the presence or absence of a living organism.
Committee |
CEN/TC 102
|
DocumentType |
Standard
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Current
|
Standards | Relationship |
DIN EN ISO 15882:2008-12 | Identical |
BS EN ISO 15882:2008 | Identical |
ISO 15882:2008 | Identical |
NS EN ISO 15882 : 2ED 2008 | Identical |
NBN EN ISO 15882 : 2008 | Identical |
PN EN ISO 15882 : 2009 | Identical |
NF EN ISO 15882 : 2010 | Identical |
I.S. EN ISO 15882:2008 | 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 |
SS-EN ISO 15882:2008 | 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/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
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/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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