scope:

This Standard applies to

(a) steam sterilizers that

(i) have a chamber volume of 42.5 L (1.5 ft³) or greater; and

(ii) are intended for use in health care facilities;

(b) emergency (flash) sterilizers; and

(c) washer-disinfectors (when used in sterilizer mode).

Notes:

(1) In this Standard, "sterilizer" is used as a blanket term for the three types of sterilizers listed in this Clause.

(2) Tests involving modifications to sterilizer controls or safety features can endanger personnel if appropriate safety precautions are not taken.

(3) See CAN/CSA-Z314.13 for recommended practices for emergency (flash) sterilization.

This Standard specifies minimum construction and performance requirements for sterilizers to ensure that

(a) the conditions required for sterilization are achieved; and

(b) the personnel who operate the equipment can perform their tasks safely.

This Standard does not cover

(a) pre- or post-sterilization procedures;

(b) operator requirements;

(c) tests for assessing the probability of product sterility; and

(d) routine quality control release tests.

The values given in SI (metric) units are the standard. The values given in parentheses are for information only.

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; and "may" is used to express an option or that which is permissible within the limits of the standard. 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. Legends to equations and figures are considered requirements.