• There are no items in your cart

DIN EN ISO 15882:2008-12

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 , PDF

Language(s)

English

Published date

01-01-2008

€131.40
Excluding VAT

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
National Annex NA (informative) 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
39
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
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
DIN ISO 8601:2006-09 DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
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
DIN EN ISO 11138-3:2015-10 (Draft) STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION PROCESSES (ISO 11138-3:2017)
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
DIN EN ISO 11138-2:2015-10 (Draft) STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES (ISO 11138-2:2017)
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
DIN ISO/TS 17665-2:2009-07 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009); German version CEN ISO/TS 17665-2:2009
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 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
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 11140-5:2007 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
DIN ISO/TS 11135-2:2010-01 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
DIN EN ISO 9001 E : 1994 QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN DESIGN/DEVELOPMENT, PRODUCTION, INSTALLATION AND SERVICING
DIN EN ISO 11138-5:2015-10 (Draft) STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZATION PROCESSES (ISO 11138-5:2017)
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.