1. Scope 1.1
This Standard is intended to assist health care facilities using ethylene oxide as a sterilant, installing new ethylene oxide sterilization equipment, or modifying existing equipment in meeting government regulations on exposure and worker safety respecting the use of ethylene oxide gas.
This Standard addresses basic issues associated with the safe use or operation of ethylene oxide sterilizers. It does not cover safety issues that are specific to individual
equipment models or to individual health care facilities. 1.2
This Standard provides information to assist health care facilities in devising work practices that will maximize employee safety when using ethylene oxide sterilizers and ancillary equipment. 1.3
This Standard includes installation and ventilation design criteria and performance specifications for ethylene oxide sterilization areas, aeration areas, and container handling and storage areas. 1.4
This Standard does not address sterilizer efficacy, which is dealt with in CSA Standard Z314.2. 1.5
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 are written as mandatory requirements. Legends to figures are also considered mandatory requirements.