CSA - CAN/CSA-Z11135:15
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
inactive
| Organization: | CSA |
| Publication Date: | 1 January 2015 |
| Status: | inactive |
| Page Count: | 100 |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
scope:
Inclusions
[Add the following]
ISO 11135 specifies requirements and guidance for the development, validation, and routine control of an ethylene oxide (EO) sterilization process for medical devices. It applies to ethylene oxide sterilization in the context of medical device manufacturing and medical device reprocessing departments. Prevention of exposure to EO and its by-products during use is important for patient and occupational safety.
CSA Z314.23 and ISO 11135 are complementary Standards to be used together for sterilization using EO.
Document History
January 1, 2015
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
Inclusions
This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the...
CAN/CSA-Z11135:15
January 1, 2015
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Inclusions
[Add the following]
ISO 11135 specifies requirements and guidance for the development, validation, and routine control of an ethylene oxide (EO) sterilization process for medical...