Historical

BS EN ISO 11135:2014

Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices (British Standard)


ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.


CONTENT PROVIDER
British Standards Institution [bsi]

Others Also Bought
Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging ...
Biological evaluation of medical devices. Tests for systemic toxicity (British Standard)
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for ...
Document History
Included in Packages
This standard is not included in any packages.
Amendments & Corrections
We have no amendments or corrections for this standard.