I.S. EN ISO 11137-2:2015/A1:2023
Current
Current
The latest, up-to-date edition.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
Amendment of
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
20-04-2023
Publisher
€107.00
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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.
Dates of withdrawal of national standards are available from NSAI.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| Pages |
70
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
Frequently Asked Questions
I.S. EN ISO 11137-2 belongs to the topic area of radiation sterilisation of healthcare products. It is an Irish standard published by National Standards Authority of Ireland (NSAI).
I.S. EN ISO 11137-2 is published by National Standards Authority of Ireland (NSAI). It is an Irish standard.
No — I.S. EN ISO 11137-2 is an Irish standard published by National Standards Authority of Ireland (NSAI), with its listed region as Ireland.
I.S. EN ISO 11137-2 is National Standards Authority of Ireland (NSAI)'s standard for radiation sterilisation of healthcare products, while AAMI ISO 11135 covers ethylene oxide sterilisation of healthcare products (United States). I.S. EN ISO 11137-2 specifies development, validation, dose establishment or routine control requirements for radiation sterilisation. AAMI ISO 11135 specifies development, validation and routine control requirements for ethylene oxide sterilisation processes.
I.S. EN ISO 11137-2 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).
€107.00
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