scope:

This Standard applies to steam sterilizers having a chamber volume of 42.5 L (1.5 ft³) or greater, intended for use in hospitals and similar health care facilities.

Notes:

(1) For the purpose of this Standard, "similar health care" includes, but is not limited to, nursing homes, extended-care facilities, clinics, medical and dental offices, and health care units in industry.

(2) This Standard is directed to manufacturers of steam sterilizers; tests involving modifications to the sterilizer controls or safety features could present hazards to those who do not possess specialized testing equipment and the expertise to conduct the tests.

Inclusions

This Standard includes minimum construction and performance requirements for steam sterilizers, with the objective of

(a) ensuring that the conditions required for sterilization are achieved in the chamber; and

(b) ensuring the safety of personnel using the equipment.

Exclusions

This Standard excludes flash sterilizers and washer/sterilizers when used in the sterilizer mode.

Note: Refer to CSA Standard CAN/CSA-Z314.13 for recommended practices in emergency (flash) sterilization.

This Standard does not stipulate pre- or post-sterilization procedures or machine operator requirements. It also does not specify the tests to be used to indicate the probability of product sterility.

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

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

In this Standard, the word "shall" indicates a mandatory requirement; "should" indicates a recommendation, which is advised but not mandatory. Notes accompanying clauses provide explanatory or informative material that is not properly a part of this Standard.