CAN/CSA-Z314.1-M91

Scope

1.1 This Standard applies to ethylene oxide sterilizers intended for use in hospitals and similar healthcare facilities.
Notes:
(1) For the purpose of this Standard, similar healthcare facilities includes, but is not limited to nursing homes, extended-care facilities, clinics, medical and dental offices, and health units in industry.
(2) This Standard is directed to manufacturers of ethylene oxide sterilizers; tests involving modifications to the sterilizer controls or safety features could present hazards to those who d o not possess specialized testing equipment and the expertise to conduct the tests.

1.2 Inclusions
This Standard includes minimum construction and performance requirements for
(a) ensuring that the environment in the sterilizing chamber is potentially effective in sterilizing products; and
(b) ensuring the safety of personnel using the equipment.
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 PR OVINCIAL REGULATIONS AND CSA STANDARD CAN/CSA-Z314.9.

1.3 Exclusions

1.3.1 This Standard does not provide for either presterilization or post-sterilization procedures or machine- operator requirements, nor does it specify those tests to be performed which are designed to indicate the probability of pro duct sterility.

1.3.2 This Standard is not intended to specify routine quality control release tests.

1.4 The values given in SI (metric) units have to be considered the standard values. The values given in parentheses are for information only.

1.5 In this Standard, the word shall indicates a mandatory requirement; should indicates a recommendation, which is advised but not mandatory. Notes accompanying clauses do not include mandatory or alternative requirements. The purpose of a note is to separate from the text explanatory or informative material that is not properly a part of this Standard.