I.S. EN ISO 11137-1:2026
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 (ISO 11137-1:2025)
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
06-25-2026
Publisher
US$88.62
Excluding Tax where applicable
Summarise this standard
AI-generated summary
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
| DocumentType |
Standard
|
| Pages |
39
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| BS EN ISO 11137-1:2026 | Equivalent |
| EN ISO 11137-1:2026 | Equivalent |
| DIN EN ISO 11137-1:2026-10 | Equivalent |
Frequently Asked Questions
I.S. EN 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.
No — I.S. EN ISO 11137-1 is an Irish standard published by National Standards Authority of Ireland (NSAI), with its listed region as Ireland.
I.S. EN ISO 11137-1 is National Standards Authority of Ireland (NSAI)'s standard for radiation sterilisation of healthcare products, while I.S. EN ISO 11135 covers ethylene oxide sterilisation of healthcare products (Ireland). I.S. EN ISO 11137-1 specifies development, validation, dose establishment or routine control requirements for radiation sterilisation. I.S. EN ISO 11135 specifies development, validation and routine control requirements for ethylene oxide sterilisation processes.
I.S. EN ISO 11137-1 is used by healthcare product manufacturers and sterilisation providers using ionising radiation. It is an Irish standard published by National Standards Authority of Ireland (NSAI).
I.S. EN ISO 11137-1 specifies development, validation, dose establishment or routine control requirements for radiation sterilisation. It is an Irish standard published by National Standards Authority of Ireland (NSAI).
US$88.62
Excluding Tax where applicable
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