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.
Status: WithdrawnPublication date: 1994-01
Edition: 1Number of pages: 24
Technical Committee: ISO/TC 198 Sterilization of health care products
- ICS :
- 11.080.01 Sterilization and disinfection in general
ISO 11135:1994Stage: 95.99
Corrigenda / AmendmentsWithdrawn
ISO 11135:1994/Cor 1:1994
Got a question?
Check out our FAQs
+41 22 749 08 88
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)
Keep up to date with ISO
Sign up to our newsletter for the latest news, views and product information.