ISO 11137-1:2025
Current
Current
Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Available format(s)
Hardcopy , PDF
Language(s)
English, French
Published date
04-02-2025
US$279.00
Excluding Tax where applicable
Summarise this standard
AI-generated summary
This document does not specify requirements for the sterilization of used or reprocessed devices.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| Pages |
39
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes | |
| UnderRevision |
| Standards | Relationship |
| SS-EN ISO 11137-1:2026 | Identical |
| BS EN ISO 11137-1:2026 | Identical |
Frequently Asked Questions
ISO 11137-1 specifies development, validation, dose establishment or routine control requirements for radiation sterilisation. It is an international standard published by International Organization for Standardization (ISO).
ISO 11137-1 is used by healthcare product manufacturers and sterilisation providers using ionising radiation. It is an international standard published by International Organization for Standardization (ISO).
ISO 11137-1 is International Organization for Standardization (ISO)'s standard for radiation sterilisation of healthcare products, while ISO 11135 covers ethylene oxide sterilisation of healthcare products (International). ISO 11137-1 specifies development, validation, dose establishment or routine control requirements for radiation sterilisation. ISO 11135 specifies development, validation and routine control requirements for ethylene oxide sterilisation processes.
ISO 11137-1 is an international standard published by International Organization for Standardization (ISO), and is applied internationally rather than in a single country.
ISO 11137-1 specifies development, validation, dose establishment or routine control requirements for radiation sterilisation. In practice it is applied by healthcare product manufacturers and sterilisation providers using ionising radiation.
US$279.00
Excluding Tax where applicable
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