ISO 11138-2-2017 PDF

Full title and description

Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes. This International Standard specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes that use ethylene oxide (pure or mixed with diluent gases) at sterilizing temperatures within the range 29 °C to 65 °C.

Abstract

ISO 11138-2:2017 defines the production, population and resistance requirements, and test methods for biological indicators (BIs) intended for evaluating ethylene oxide (EO) sterilization processes. It complements process validation and control standards (for example ISO 11135 and ISO 14937) and includes a normative method for D-value determination (Annex A) and an informative rationale for D-value specifications (Annex B).

General information

• Status: Published (confirmed in systematic review).
• Publication date: March 2017 (published 2017-03).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.080.01 (Sterilization and disinfection in general); related classifications also reference disinfectants/antiseptics.
• Edition / version: 3 (ISO 11138-2:2017).
• Number of pages: 6 (official ISO publication page lists 6 pages).

Scope

The standard applies to biological indicators and associated test methods used to assess the performance of EO sterilizers and EO sterilization processes at temperatures from 29 °C to 65 °C. It sets requirements for selection and preparation of test organisms and suspensions, inoculated carriers and primary packaging, population and resistance specifications for BIs, and the laboratory method for determination of resistance (D values). It is intended to be used alongside process validation/control standards such as ISO 11135 and ISO 14937.

Key topics and requirements

• Defined test organisms and suspensions for EO BIs (commonly Bacillus species appropriate for EO applications).
• Population requirements for inoculated carriers/BI units (typical viable count minima specified by the standard).
• Resistance expressed as D values; the standard specifies D-value determination at reference conditions (D value reported at 54 °C) and includes minimum D-value specifications relevant to specified test gases.
• Normative method for determination of resistance to EO sterilization (Annex A) and an informative annex explaining rationale for D‑value specifications (Annex B).
• Requirements for carriers and primary packaging suitability and for documentation/labeling of BIs intended for use in validation and routine monitoring.

Typical use and users

Used by biological indicator manufacturers, sterilization equipment manufacturers, validation and quality engineers, hospital sterile processing departments, contract sterilizers and regulatory bodies to select, produce, test and interpret biological indicators for EO sterilization process development, validation and routine monitoring. The standard is intended to support consistent, comparable BI performance specifications.

Related standards

ISO 11138-2 is part of the ISO 11138 series on biological indicators (see ISO 11138-1, -3, -4, -5, etc.). It should be used in conjunction with ISO 11135 (requirements for development, validation and routine control of EO sterilization processes) and ISO 14937 (general characterization of sterilization processes) for process validation and control. Regional/adopted versions (EN ISO 11138-2) and companion parts covering moist heat, dry heat and low-temperature processes are also relevant.

Keywords

biological indicator; BI; ethylene oxide; EO sterilization; inoculated carrier; test organism; Bacillus; D value; resistance; sterilizer validation; ISO 11138; ISO 11135.

FAQ

Q: What is this standard?

A: ISO 11138-2:2017 is the part of the ISO 11138 series that specifies requirements and test methods for biological indicators used with ethylene oxide sterilization processes.

Q: What does it cover?

A: It covers selection and preparation of test organisms and suspensions, inoculated carriers and primary packaging, population and resistance requirements for biological indicators, methods for determining resistance (D values), and related documentation and labeling expectations for EO BIs.

Q: Who typically uses it?

A: Manufacturers of biological indicators, sterilizer manufacturers, validation and quality assurance engineers, hospital sterile processing teams, contract sterilization providers and regulatory assessors. The standard supports BI selection, manufacture, testing and interpretation for EO process monitoring and validation.

Q: Is it current or superseded?

A: ISO 11138-2:2017 (third edition) was published in March 2017 and was systematically reviewed and confirmed in 2022; it remains the current edition.

Q: Is it part of a series?

A: Yes — it is Part 2 of the ISO 11138 series on biological indicators. Other parts address moist heat, dry heat, low-temperature steam/formaldehyde and general requirements (ISO 11138-1, -3, -4, -5, etc.).

Q: What are the key keywords?

A: Biological indicator, ethylene oxide, EO, D value, Bacillus, inoculated carrier, sterilizer validation, ISO 11138, test organism.