ISO 11138-3-2017 PDF

Full title and description

Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes. This part of ISO 11138 specifies production, performance and test requirements for biological indicators, inoculated carriers, test organisms and related test methods intended to assess the performance of sterilization processes that use moist heat (steam) as the sterilizing agent.

Abstract

ISO 11138-3:2017 defines requirements for test organisms, suspensions, inoculated carriers, biological indicators (BIs) and test methods used to evaluate moist heat (steam) sterilization processes. It complements the ISO 17665 series (validation and control of moist heat sterilization) and provides normative and informative provisions for resistance determination, population reporting and carrier/packaging suitability.

General information

• Status: Published (confirmed in systematic review 2022).
• Publication date: March 2017 (Edition 3; published 2017‑03‑03 as the International Standard).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.080.01 (Sterilization and disinfection in general).
• Edition / version: Edition 3 (2017).
• Number of pages: 8 pages.

Scope

Specifies requirements and test methods for biological indicators, inoculated carriers, test organisms and suspensions intended for use in assessing the performance of sterilization processes employing moist heat (dry saturated steam). The document addresses production and characterization of indicators, resistance measurement (D and z values), suitability of carriers and primary packaging for the intended test exposures, and requirements for reporting population and resistance characteristics. It is intended to be used together with ISO 11138‑1 (general requirements) and the ISO 17665 series (validation and routine control of moist heat sterilization).

Key topics and requirements

• Test organism: spores of Geobacillus stearothermophilus are specified as the reference organism for moist heat; alternatives require demonstrated equivalence.
• Resistance metric: resistance is expressed as D value at 121 °C (D121) and must be reported to one decimal place; typical minimum performance criteria (as used by manufacturers/test reports) are specified for population and resistance characterization.
• Thermal resistance characterization: z value must be determined from D values at not fewer than three temperatures (commonly in the 110 °C–138 °C range) and calculated by regression; z‑value calculation and reporting requirements are specified.
• Test methods: normative annexes describe moist‑heat resistance test procedures (resistometer test cycles) and statistical calculations for D and z determination; test equipment/parameters reference ISO 18472 where appropriate.
• Carrier and primary packaging suitability: manufacturers must demonstrate that carriers and the indicator primary packaging are compatible with the defined moist‑heat exposure conditions used during resistance testing and routine use.
• Population and labelling: viable count (population) and resistance characteristics must be stated on product documentation; batch/lot reporting and traceability requirements are defined to support validation and routine monitoring use.
• Application contexts: guidance for use in validation, requalification, routine monitoring and supplier quality control for biological indicators used with steam sterilizers.

Typical use and users

Intended users include manufacturers of biological indicators and inoculated carriers, sterilizer and medical device manufacturers, sterilization validation and quality assurance engineers, hospital sterilization departments, test laboratories and regulatory bodies involved in sterilization conformity assessment. Typical uses are production specification and quality control of BIs, determination of D and z values for indicator lots, validation and routine monitoring of steam autoclaves, and comparative performance testing.

Related standards

ISO 11138-3:2017 is part of the ISO 11138 series. Key related documents include ISO 11138‑1 (general requirements for biological indicators), the ISO 17665 series (validation and routine control of moist heat sterilization processes), ISO 18472 (resistometer/test equipment parameters for biological and chemical indicators) and ISO 14161 (guidance on selection, use and interpretation of biological indicators).

Keywords

biological indicator, moist heat sterilization, steam sterilization, Geobacillus stearothermophilus, D value, z value, inoculated carrier, resistometer, sterilizer validation, ISO 11138, ISO 17665.

FAQ

Q: What is this standard?

A: ISO 11138-3:2017 is the part of the ISO 11138 series that sets requirements and test methods for biological indicators and inoculated carriers used specifically for moist heat (steam) sterilization processes.

Q: What does it cover?

A: It covers selection and preparation of test organisms and suspensions, design and production of inoculated carriers and biological indicators, methods for determining thermal resistance (D and z values), carrier/packaging suitability, labelling and reporting of population and resistance data, and the required test procedures (including resistometer methods in annexes).

Q: Who typically uses it?

A: Manufacturers of biological indicators and inoculated carriers, sterilizer manufacturers, validation and QA engineers, hospital sterilization services, test laboratories and regulatory bodies use the standard for indicator specification, validation, routine monitoring and conformity assessment.

Q: Is it current or superseded?

A: The Edition 3 text published in March 2017 is the current published version and was confirmed in ISO’s 2022 systematic review; it replaced earlier editions (for example the 2006 edition). Users should check their national standards body for any national amendments.

Q: Is it part of a series?

A: Yes — ISO 11138‑3 is Part 3 of the ISO 11138 series (biological indicators). It is intended to be used together with ISO 11138‑1 and other parts of the series plus the ISO 17665 series for moist heat sterilization validation and control.

Q: What are the key keywords?

A: Key keywords are biological indicator, moist heat/steam sterilization, Geobacillus stearothermophilus, D value, z value, inoculated carrier, resistometer, sterilizer validation, ISO 11138.