1. Scope Caution: ETHYLENE OXIDE IN LIQUID AND VAPOUR FORM IS ACUTELY TOXIC AND HAS BEEN
CLASSIFIED AS A HUMAN CARCINOGEN BY THE INTERNATIONAL AGENCY FOR RESEARCH ON
CANCER. FOR PROVISION OF ADEQUATE PROTECTION AGAINST THESE EFFECTS, REFER TO
FEDERAL AND PROVINCIAL REGULATIONS AND TO CSA STANDARD Z314.9. 1.1
This Standard outlines essential elements in a program for using ethylene oxide
to sterilize products in health care facilities in order to achieve an adequate
level of sterility assurance and to minimize the risk of injury to patients and
to the health and safety of staff. This standard applies to all sterilization
processes that use an ethylene oxide sterilizer in accordance with CSa
Standards Z314.1 and Z314.9.
Notes:
1) The term "health care facilities" includes, but is not limited to,
hospitals, nursing homes, extended-care facilities, clinics, medical and dental
offices, and health units in industry.
(2) Figure 1 shows the scope of this Standard within the reprocessing of
reusable medical devices.
(3) Comprehensive guidance for small, office-based facilities can be found in
CSA Publication PLUS 1112. 1.2
This Standard includes requirements for
(a) work areas;
(b) personnel qualifications and training;
(c) preparation and packaging of medical devices requiring sterilization;
(d) sterilizer loading and operation;
(e) aeration following sterilization;
(f) storage of sterilized medical devices;
(g) sterility assurance, including test pack construction and use;
(h) product evaluation for sterilizable products and packaging materials; and
(i) maintenance and sterilizer quality assurance. 1.3
This Standard does not apply to
(a) construction and performance of ethylene oxide sterilizers;
Note: See CSA Standard Z314.1.
(b) installation and ventilation of ethylene oxide sterilizers; and
Note: See CSA Standard Z314.9,
(c) decontamination of reusable medical devices prior to sterilization.
Note: See CSA Standard Z314.8. 1.4
In this Standard, "shall" indicates a mandatory requirement; "should" indicates
a recommendation or that which is advised but not mandatory; and "may"
indicates an advisory or optional statement. Notes accompanying clauses do not
include mandatory or alternative requirements; the purpose of a note
accompanying a clause is to separate from the text explanatory or informative
material that is not properly a part of the Standard. Notes to figures and
tables are considered part of the figure or table and may be written as
mandatory requirements; legends to figures are also considered part of the
requirements of the figure.