ISO 11137-3-2017 PDF

Full title and description

ISO 11137-3:2017 — Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control. This part provides practical guidance on dosimetry and dose measurement needed to support the development, validation and routine control of radiation sterilization processes for health-care products.

Abstract

ISO 11137-3:2017 gives guidance on meeting the dosimetric requirements referenced in ISO 11137‑1 and ISO 11137‑2 and on the use of dosimetry for development, validation and routine control of radiation sterilization. It covers selection and calibration of dosimetry systems, measurement uncertainty, dose mapping and traceability to national standards, and how dosimetric data can be applied to support process validation and ongoing control.

General information

• Status: Published (current edition confirmed after review in 2022).
• Publication date: June 2017 (Edition 2, 2017).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.080.01 (Sterilization and disinfection in general).
• Edition / version: Edition 2 (2017).
• Number of pages: 41 pages (ISO edition). Note: some national/adopted versions list slightly different pagination (formatting differences).

Scope

This document provides guidance to fulfil the dosimetry-related requirements of ISO 11137‑1 and ISO 11137‑2 and to support development, validation and routine control of a radiation sterilization process. Topics include selection and use of dosimetry systems, calibration and traceability, estimation and reporting of measurement uncertainty, dose mapping protocols for product loads and facilities, and interpretation of dosimetric results for validation and routine monitoring. The guidance applies to gamma, electron beam and X‑ray irradiation used for sterilization of health‑care products.

Key topics and requirements

• Principles of dosimetry applicable to radiation sterilization (gamma, e‑beam, X‑ray).
• Selection, calibration and traceability of dosimetry systems and reference standards.
• Guidance on establishing and documenting measurement uncertainty and associated quality control.
• Procedures for dose mapping of product loads and irradiator facilities to demonstrate dose uniformity and coverage.
• Dosimetric data requirements to support development, validation and routine process control.
• Recommendations for routine dosimetry checks and corrective actions when deviations are found.

Typical use and users

Primary users are medical device and health‑care product manufacturers, contract sterilization service providers, applied dosimetrists, testing and calibration laboratories, regulatory compliance teams and notified bodies. The standard is used when developing or validating radiation sterilization processes, when selecting and calibrating dosimetry systems, and for establishing routine dosimetric control and documentation.

Related standards

ISO 11137‑3:2017 is part of the ISO 11137 series and is intended to be used with: ISO 11137‑1 (requirements for development, validation and routine control), ISO 11137‑2 (methods for establishing the sterilization dose), ISO/TS 11137‑4 (guidance on process control), and related technical specifications such as ISO/TS 13004 (dosimetric methods for substantiation). Other related standards referenced for sterilization indicators and testing include ISO 11140 series.

Keywords

radiation sterilization; dosimetry; dose mapping; dose measurement; calibration; traceability; measurement uncertainty; validation; routine control; medical device sterilization.

FAQ

Q: What is this standard?

A: ISO 11137‑3:2017 is the third part of the ISO 11137 series; it provides guidance on dosimetric aspects for development, validation and routine control of radiation sterilization processes for health‑care products.

Q: What does it cover?

A: It covers selection and use of dosimetry systems, calibration and traceability, estimation of measurement uncertainty, dose mapping procedures, interpretation of dosimetric results, and how dosimetric data support process validation and routine monitoring.

Q: Who typically uses it?

A: Medical device manufacturers, contract sterilizers, dosimetry laboratories, regulatory and quality assurance personnel, and others responsible for establishing or maintaining radiation sterilization processes.

Q: Is it current or superseded?

A: The 2017 edition (Edition 2) is the current published version and was reviewed and confirmed in 2022. Organizations should check their national adoption for local publication dates or amendments.

Q: Is it part of a series?

A: Yes — it is Part 3 of the ISO 11137 series; it is intended to be used together with ISO 11137‑1 and ISO 11137‑2 and complemented by ISO/TS 11137‑4 and related technical specifications.

Q: What are the key keywords?

A: Radiation sterilization, dosimetry, dose mapping, calibration, measurement uncertainty, validation, routine control, medical devices.