ISO 11137-1-2025 PDF

Full title and description

St ISO 11137-1-2025 — Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. This edition defines requirements and expected controls for establishing and maintaining a radiation sterilization process (including process development, validation and routine release) for medical devices processed with cobalt or caesium sources, electron beams or X-ray beams.

Abstract

ISO 11137-1:2025 specifies the requirements for development, validation and routine control of radiation sterilization processes used for medical devices. It aligns with related dose-setting and dosimetry guidance in the ISO 11137 family and introduces updated normative references, clarified dosimetry language and revised process-control/induced-radioactivity limits to reflect technological progress.

General information

• Status: Published.
• Publication date: 02 April 2025 (Edition 2, published April 2025).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.080.01 (Sterilization and disinfection in general).
• Edition / version: Edition 2 (2025).
• Number of pages: 39 pages.

Scope

Applies to development, validation and routine control of radiation sterilization processes for medical devices. The standard covers irradiation using radionuclides (60Co, 137Cs), electron-beam generators and X-ray generators. It is not intended for processes whose primary purpose is viral inactivation or for inactivation of agents that cause transmissible spongiform encephalopathies. The document is written for medical devices but may be applied to other products where appropriate.

Key topics and requirements

• Requirements for process development and validation: establishing sterilization dose, acceptance criteria and validation protocols for radiation processes.
• Routine process control and release: guidance on batch release, monitoring of process parameters and options for parametric/machine-based release where control systems permit.
• Dosimetry and dose verification: alignment with dosimetry guidance (ISO 11137-3, ISO 13004 and related references) and clarified wording on when dosimetry is required.
• Updated technical limits and safety: revised guidance on induced radioactivity limits for electron and X‑ray energies and enhanced requirements to prevent control failures and ensure reliable recording of process parameters.
• Integration with the ISO 11137 series: references and normative links to parts 2 and 3 (dose setting and dosimetric aspects) and to related technical specifications.

Typical use and users

Used by medical device manufacturers, contract sterilization facilities, quality and regulatory affairs professionals, process validation engineers, dosimetrists and clinical device reviewers. It supports compliance activities, regulatory submissions and design/control of production sterilization processes.

Related standards

Part of the ISO 11137 family: ISO 11137-2 (establishing the sterilization dose), ISO 11137-3 (dosimetric aspects) and ISO/TS 11137-4 (process control guidance). The 2025 edition also references ISO 13004 and ISO/ASTM 52628 among its normative references to harmonize dosimetry and terminology.

Keywords

radiation sterilization, medical devices, validation, dosimetry, sterilization dose, electron beam (e-beam), X-ray irradiation, cobalt-60, process control, induced radioactivity, VDmax, ISO 11137.

FAQ

Q: What is this standard?

A: ISO 11137-1:2025 is the second-edition international standard that sets requirements for development, validation and routine control of radiation sterilization processes for medical devices.

Q: What does it cover?

A: It covers process development, validation protocols, routine release criteria and controls for radiation sterilization using radionuclide sources (60Co/137Cs), electron beams and X-ray beams; it also clarifies dosimetry expectations and establishes updated technical limits and control requirements. It is not intended for virus-inactivation processes or prion inactivation.

Q: Who typically uses it?

A: Medical device manufacturers, sterilization service providers, QA/regulatory teams, validation engineers and dosimetry specialists use the standard to design, validate and control radiation sterilization processes and to support regulatory submissions.

Q: Is it current or superseded?

A: ISO 11137-1:2025 is the current published edition (Edition 2, published April 2025). It replaces the earlier 2006 edition and its amendments (withdrawn).

Q: Is it part of a series?

A: Yes — it is Part 1 of the ISO 11137 series. Complementary documents include ISO 11137-2 (dose setting), ISO 11137-3 (dosimetry) and ISO/TS 11137-4 (process control guidance).

Q: What are the key keywords?

A: Radiation sterilization; validation; dosimetry; sterilization dose; e‑beam; X‑ray; cobalt‑60; process control; medical devices; induced radioactivity.