Installation, ventilation, and safe use of ethylene oxide sterilizers in health care facilities

Designation Number:
CAN/CSA-Z314.9-09 (R2013)
Standard Type:
National Standard of Canada - Domestic
Standard Development Activity:
Withdrawal
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

Scope

1.1
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.

1.2
This Standard specifies requirements for the following:
(a) the installation of ethylene oxide sterilization equipment;
(b) general area and local exhaust ventilation;
(c) staff training;
(d) monitoring alarm systems; and
(e) contingency planning.

1.3
This Standard does not address sterilizer efficacy, which is dealt with in CSA Z314.2.

1.4
This Standard does not cover safety issues that are specific to individual equipment models or to individual health care facilities.

1.5
In CSA Standards, "shall" is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; "should" is used to express a recommendation or that which is advised but not required; "may" is used to express an option or that which is permissible within the limits of the standard; and "can" is used to express possibility or capability. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Notes to tables and figures are considered part of the table or figure and may be written as requirements. Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application

Project need:

Project Need
These outdated CSA standards, if reaffirmed, may mislead manufacturers bringing their products to Canada, to believe they must comply with these documents. Health Canada medical device licensing does not require conformity to these standards

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.