scope:

This Standard addresses the construction of in-house prepared

(a) air detection (Bowie-Dick) test packs for prevacuum steam sterilizers; and

(b) installation and routine biological challenge test packs for steam and ethylene oxide sterilizers.

This Standard describes the procedures to be followed when using test packs.

This Standard defines performance requirements for commercially prepared air detection and biological challenge test packs.

This Standard is restricted to test packs used

(a) in a hospital institution; and

(b) to monitor steam and ethylene oxide sterilization.

Excluded from this Standard are biological indicators for use in table-top steam sterilizers.

The value given in SI (metric) units shall 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, that which is advised but not mandatory. Notes accompanying clauses do not include mandatory or alternative requirements. The purpose of a note is to separate from the text explanatory or informative material that is not properly a part of the Standard.