scope:

This Standard defines essential elements for using ethylene oxide to sterilize products in hospitals and similar health care facilities with the object of achieving an adequate level of sterility assurance and minimizing the risk of injury to patients and to the health and safety of hospital staff.

Note: ",Similar health care facilities* are considered to Indude nursing homes, extended-care fadlities, dinics, medical and dental offices, and health units in Industry. For convenience, the shorter term "hospital" is used herein.

Inclusions

This Standard includes requirements for

(a) preparation and packaging of products requiring sterilization;

(b) machine loading and operation;

(c) aeration and storage of sterilized products;

(d) sterility assurance;

(e) purchase agreements regarding sterilizable products and packaging materials; and

(f) maintenance and sterilizer quality assurance.

Exclusions

This Standard does not Include specific requirements for construction and performance of ethylene oxide sterilizers.

The values given in SI (metric) units shall be considered the standard values. The values given in parenthesis are included for information only.

In this Standard the word "shall" indicates a mandatory requirement; "should" indicates a recommendation, which is advised but not mandatory. Notes accompanying clauses provide explanatory or informative material that is not properly a part of the Standard.

Caution: ETHYLENE OXIDE IN LIQUID AND VAPOUR FORM IS ACUTELY TOXIC AND IS A SUSPECTED HUMAN CARCINOGEN. FOR PROVISION OF ADEQUATE PROTECTION AGAINST THESE EFFECTS REFER TO FEDERAL AND PROVINCIAL REGULATIONS AND CSA STANDARD CAN/CSA-Z314.9.