ISO 11140-4:2007 PDF

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

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Title (English):

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

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 35
Publication date:: March 15, 2007
Edition:: ISO IS 11140 edition 2 version 1
ICS:: 11.080.01

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Description (English):

ISO 11140-4:2007 specifies the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc. and porous loads). An indicator complying with ISO 11140-4:2007 incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. ISO 11140-4:2007 does not specify requirements for the test load, but specifies the performance of the indicator in combination with the test load with which it is intended to be used. The indicator specified in ISO 11140-4:2007 is intended to identify poor steam penetration but does not necessarily indicate the cause of this poor steam penetration. This part of ISO 11140-4:2007 does not include test methods to establish the suitability of these indicators for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.

Technical details

Technical committee: ISO/TC 198 - Sterilization of health care products
SKU: ISO 11140-4:2007

Abstract

Overview

ISO 11140-4:2007 defines performance requirements for Class 2 chemical indicators used as an alternative to the Bowie and Dick-type test for detection of steam penetration in steam sterilizers processing wrapped health care goods and porous loads. The standard specifies how an indicator system combined with a defined test load (pre‑assembled or user‑assembled) must perform to identify inadequate steam penetration. It clarifies scope and limits (for example, it does not include test methods for sterilizers whose air‑removal stage does not evacuate below atmospheric pressure) and establishes the expectation that an indicator shows poor steam penetration but not necessarily the underlying cause.

Key topics and requirements

Performance-based specification: The document specifies the required performance of the indicator system when used with its intended test load rather than prescribing exact test‑load materials.
Indicator/test‑load pairing: Indicators may be supplied incorporated into a test load (single use) or intended to be used with a reusable test load; the combined system performance is the subject of assessment.
Air‑removal test cycles: Compliance testing uses sub‑atmospheric, trans‑atmospheric and super‑atmospheric air‑removal stages, unless an indicator is intended for a single air‑removal type.
Temperature and instrumentation: Thermometric recording with multiple sensors is required. Sensors must meet accepted tolerances (e.g., Class A platinum resistance or equivalent thermocouples), have fast response (specified response time), and recording equipment must sample and record at short intervals to capture exposure time and temperature bands.
Indicator format and durability: If reagent is applied to a substrate, coverage and distribution rules apply (minimum coverage and spacing to ensure interpretable color change). The indicator must withstand steam sterilization and handling; packaging, labelling and quality assurance requirements are also covered.
Normative test methods (annexes): The standard includes annexes covering test cycles, equivalence determination to Bowie and Dick tests, reproducibility of fail conditions, shelf life, accelerated ageing, steam exposure apparatus, and standard test packs.

Applications and users

Sterilizer manufacturers and designers - to validate and demonstrate sterilizer performance for wrapped goods and porous loads.
Sterile Processing Departments (SPDs) / Biomedical engineers - for routine daily Bowie‑and‑Dick‑type testing alternatives and quality control of steam penetration.
Indicator and test‑pack manufacturers - to design, test and certify Class 2 chemical indicators and associated test loads.
Regulatory and compliance teams - to interpret performance requirements for sterilization assurance and integration with validation protocols (e.g., ISO 17665-1).

Related standards

ISO 11140‑1 - Chemical indicators - General requirements
ISO 11140‑3 - Class 2 indicator systems for Bowie and Dick‑type test
ISO 17665‑1 - Sterilization of health care products - validation and routine control
EN 285 - Steam sterilizers - Large sterilizers

Keywords: ISO 11140-4:2007, Class 2 indicator, Bowie and Dick, steam penetration, chemical indicators, steam sterilizer, test pack, sterilization validation.

Related standards

Standards mentioned in the description

Abstract

Overview

Key topics and requirements

Performance-based specification: The document specifies the required performance of the indicator system when used with its intended test load rather than prescribing exact test‑load materials.
Indicator/test‑load pairing: Indicators may be supplied incorporated into a test load (single use) or intended to be used with a reusable test load; the combined system performance is the subject of assessment.
Air‑removal test cycles: Compliance testing uses sub‑atmospheric, trans‑atmospheric and super‑atmospheric air‑removal stages, unless an indicator is intended for a single air‑removal type.
Temperature and instrumentation: Thermometric recording with multiple sensors is required. Sensors must meet accepted tolerances (e.g., Class A platinum resistance or equivalent thermocouples), have fast response (specified response time), and recording equipment must sample and record at short intervals to capture exposure time and temperature bands.
Indicator format and durability: If reagent is applied to a substrate, coverage and distribution rules apply (minimum coverage and spacing to ensure interpretable color change). The indicator must withstand steam sterilization and handling; packaging, labelling and quality assurance requirements are also covered.
Normative test methods (annexes): The standard includes annexes covering test cycles, equivalence determination to Bowie and Dick tests, reproducibility of fail conditions, shelf life, accelerated ageing, steam exposure apparatus, and standard test packs.

Applications and users

Sterilizer manufacturers and designers - to validate and demonstrate sterilizer performance for wrapped goods and porous loads.
Sterile Processing Departments (SPDs) / Biomedical engineers - for routine daily Bowie‑and‑Dick‑type testing alternatives and quality control of steam penetration.
Indicator and test‑pack manufacturers - to design, test and certify Class 2 chemical indicators and associated test loads.
Regulatory and compliance teams - to interpret performance requirements for sterilization assurance and integration with validation protocols (e.g., ISO 17665-1).

Related standards

ISO 11140‑1 - Chemical indicators - General requirements
ISO 11140‑3 - Class 2 indicator systems for Bowie and Dick‑type test
ISO 17665‑1 - Sterilization of health care products - validation and routine control
EN 285 - Steam sterilizers - Large sterilizers

Keywords: ISO 11140-4:2007, Class 2 indicator, Bowie and Dick, steam penetration, chemical indicators, steam sterilizer, test pack, sterilization validation.

ISO 11140-4:2007 PDF

Technical details

Abstract

Overview

Key topics and requirements

Applications and users

Related standards

Related standards

Abstract

Overview

Key topics and requirements

Applications and users

Related standards

Related standards

Sterilization of health care products. Moist heat - Guidance on the application of ISO 17665-1

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)

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