ISO 11135:1994 PDF
Medical devices — Validation and routine control of ethylene oxide sterilization
Title (English):
ISO 11135:1994
Medical devices — Validation and routine control of ethylene oxide sterilization
- Document status:
- Withdrawn
- Format:
- Electronic (PDF)
- Number of pages:
- 24
- Publication date:
- January 27, 1994
- Edition:
- ISO IS 11135 edition 1 version 1
- ICS:
- 11.080.01
Description (English):
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.
Technical details
- Technical committee
- ISO/TC 198 - Sterilization of health care products
- SKU
- ISO 11135:1994
