ANSI/AAMI/ISO 11135:2014/A1:2018
Current
Sterilization of healthcare products—Ethylene oxide—Requirements for the development, validation and routine control of a sterilization process for medical devices—Amendment 1: Revision of Annex E, Single batch release
English
02-13-2020
Specifies the requirements for the release of product from a single batch for a sterilization process where there is only sufficient product, at most, for a single sterilization load, for example, during research and development of new product or for clinical trial product.
| Committee |
WG 01
|
| DocumentType |
Amendment
|
| ISBN |
978-1-57020-745-7
|
| Pages |
14
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
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