• Shopping Cart
    There are no items in your cart

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 (ISO 15882:2008)

Published date

01-09-2008

Sorry this product is not available in your region.

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

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

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.