ISO 11135:1994
Withdrawn
View Superseded by
Medical devices — Validation and routine control of ethylene oxide sterilization
Hardcopy , PDF
01-27-1994
11-02-2025
Establishes requirements and guidance. Particular attention is drawn to the need for specific testing for safety, quality and efficacy, possibly exceeding the general requirements, which may be necessary for a specific product. Attention is drawn to the existence in some countries of regulations laying down safety requirements for handling ethylene oxide and for premises in which it is used as well as of regulations laying down limits for the level of ethylene oxide residues within medical devices and products.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| AS ISO 11135-2002 | Identical |
| AAMI/ISO/ IEC Guide 63:2019 | Guide to the development and inclusion of aspects of safety in International Standards for medical devices |
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