scope:

This Standard defines essential in a program for using steam to sterilize medical products in hospitals and similar health care facilities with the object of achieving an adequate level of sterility assurance and minimizing the risk of injury to the operations of steam sterilization equipment.

Note: "Similar health care facilities" includes nursing hames, extended-care facilities, clinics, medical and dental offices, health units in industry, and other privately-owned medical facilities. For convenience, the shorter term "hospital" is used herein.

Inclusions

This Standard includes requirements for

(a) Preparation and packaging of products requiring sterilization;

(b)Sterilizer loading and operation;

(c)Storage of sterilized products;

(d)Sterility assurance;

(e)Purchase agreement regarding sterilizable products and packing materials; and

(f)Maintenance and sterilizer quality assurance.

Exclusions

(a)This Standard does not apply to flash sterilizers or to washer/sterilizers.

Note: Refer to CSA Standard CAN/CSA-Z314.13.

(b)This Standard does not include specific requirements for the construction and performance of steam sterilizers.

Note: Refer to CSA Standard CAN/CSA-Z314.7.

The values given in SI (metric) units shall be considered the standard values. The values given in parantheses are included 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 property a part of this Standard.