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RS 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

Abstract

1.1 This document specifies requirements for the development, validation and routine control of a
radiation sterilization process for medical devices.
NOTE Although the scope is limited to medical devices, this document can be applicable to other products and
equipment.
This document covers radiation processes employing irradiators using:
a) the radionuclide 60Co or 137Cs;
b) a beam from an electron generator; or
c) a beam from an X-ray generator.
1.2 This document is not applicable to processes for inactivating viruses or the causative agents of
spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob
disease.
NOTE For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A.
1.2.1 This document does not specify requirements for designating a medical device as sterile.
NOTE Regional and national requirements can designate medical devices as sterile. See, for example, EN 556-1 or
ANSI/AAMI ST67.
1.2.2 This document does not specify a quality management system for the control of all stages of
production of medical devices.
NOTE It is not a requirement of this document to have a complete quality management system during manufacture,
but the elements of a quality management system that are the minimum necessary to control the sterilization process
are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the
standards for quality management systems (see ISO 13485) that control all stages of production of medical devices,
including the sterilization process. Regional and national regulations for the provision of medical devices can require
implementation of a complete quality management system and the assessment of that system by a third party.
1.2.3 This document does not require that biological indicators be used for validation or monitoring of
radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product
release.
1.2.4 This document does not specify requirements for occupational safety associated with the design
and operation of irradiation facilities.
NOTE Regulations on safety requirements for occupational safety related to radiation can exist in some countries.

General Information

Code	Classification	Theme	Pages	Publisher	Availability
RS ISO 11137-1: 2025	ADOPTED ISO STANDARDS	Electrical engineering	51	Second Edition Jul 2026	Available