ISO 11137-2-2013 PDF

Full title and description

ISO 11137-2:2013 — Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose. This international standard specifies methods for determining the minimum radiation dose required to achieve a specified sterility requirement (typically an SAL of 10−6), and methods to substantiate the use of preselected doses (notably 25 kGy and 15 kGy). It also covers procedures for ongoing sterilization dose audit and defines product-family concepts for dose establishment and auditing.

Abstract

ISO 11137-2:2013 describes practical methods for setting and substantiating radiation sterilization doses for health-care products. It includes dose‑setting approaches based on product bioburden (Method 1), on fraction‑positive incremental dosing (Method 2), and the verification‑dose (VDmax) approach to substantiate commonly used preselected doses (15 kGy and 25 kGy). The standard also specifies how to perform sterilization dose audits to demonstrate continued effectiveness of the chosen dose and defines grouping criteria (product families) for dose establishment and audit programs.

General information

• Status: Published (confirmed current on review in 2024)
• Publication date: June 2013
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.080.01 (Sterilization of medical devices)
• Edition / version: Edition 3 (2013); Amendment 1 issued (2022)
• Number of pages: 68

Scope

This part of ISO 11137 specifies methods to determine the sterilization dose required to achieve a specified sterility assurance level (SAL) for health‑care products that are sterilized by ionizing radiation. It gives procedures for dose‑setting (Method 1 and Method 2), for substantiating preselected doses using the VDmax (verification dose) approach (notably 15 kGy and 25 kGy), and for performing sterilization dose audits to verify ongoing control. The standard also defines how to group products into families for dose establishment and audit purposes. It does not replace requirements for packaging, process control, or dose‑measurement accuracy, which are addressed in other parts of the ISO 11137 series.

Key topics and requirements

• Definitions and product‑family concepts for grouping similar medical devices for dose setting and audit.
• Method 1 — dose setting using measured bioburden and established statistical models.
• Method 2 — dose setting using fraction‑positive results from incremental dosing and extrapolation factors.
• Method VDmax — verification/ substantiation method for preselected doses (originally focused on 25 kGy and 15 kGy; later amendments and technical reports extend guidance for other preselected doses).
• Sterilization dose audit procedures for routine verification of continued effectiveness of the selected sterilization dose.
• Worked examples and practical guidance on sample sizes, testing, and acceptance criteria (e.g., fraction‑positive thresholds used in VDmax verification experiments).
• Requirements to coordinate dose‑setting with dose measurement and process control standards (other parts of ISO 11137 and associated technical reports).

Typical use and users

Manufacturers of single‑use medical devices and health‑care products that are sterilized by ionizing radiation, contract sterilization facilities, regulatory and quality assurance personnel, and testing laboratories use ISO 11137-2 when establishing or substantiating a sterilization dose. It is used during product development, premarket validation, change control, and routine dose audits to demonstrate that a chosen radiation dose achieves the required sterility assurance level without undue product damage.

Related standards

Key related documents in the radiation sterilization family and supporting guidance include ISO 11137-1 (requirements for development, validation and routine control of a sterilization process for medical devices), ISO 11137-3 (dosimetry requirements), ISO/TS 13004 (guidance on VD methods and dose substantiation for selected doses), ISO/TS or Technical Specifications and technical reports that support implementation (for example guidance from AAMI that aligns with ISO 11137 parts), and ISO/TS 11137-4 (process control and monitoring guidance).

Keywords

radiation sterilization, sterilization dose, SAL, sterilization dose audit, VDmax, bioburden, Method 1, Method 2, product family, dose substantiation, ISO 11137

FAQ

Q: What is this standard?

A: ISO 11137-2:2013 is the part of the ISO 11137 series that specifies methods for establishing and substantiating radiation sterilization doses for health‑care products and for conducting dose audits to confirm continued effectiveness.

Q: What does it cover?

A: It covers practical dose‑setting methods (Method 1 and Method 2), the VDmax verification approach for substantiating preselected doses (notably 25 kGy and 15 kGy), product‑family definitions for dose establishment and audit, and procedures for sterilization dose audit and routine verification.

Q: Who typically uses it?

A: Device manufacturers, contract sterilizers, quality/validation engineers, testing laboratories, and regulatory compliance personnel involved with radiation sterilization of medical devices.

Q: Is it current or superseded?

A: ISO 11137-2:2013 is the published third edition from June 2013 and was confirmed on review in 2024; an amendment (Amd 1) was published (2022) to extend/clarify some substantiation options. A newer revision/committee draft to replace the 2013 edition has been under development, but until a replacement edition is published the 2013 edition (with its amendment) remains the effective document. Users should confirm the edition and any amendments with their national standards body before relying on it for compliance.

Q: Is it part of a series?

A: Yes — ISO 11137 is a multi‑part series on radiation sterilization. Part 1 covers development, validation and routine control of a sterilization process; Part 2 covers dose establishment (this document); Part 3 covers dosimetry; and additional technical specifications and reports provide supporting guidance (e.g., ISO/TS 13004, ISO/TS 11137-4).

Q: What are the key keywords?

A: radiation sterilization, sterilization dose, SAL 10−6, bioburden, VDmax, dose audit, Method 1, Method 2, product family, ISO 11137