b)
Sterility of the loads should be evidenced by the killing of
all spores on the spore strip as determined by the sterility
testing procedures recommended in the U.S. Pharmacopoeia.
c)
Moisture retained in each pack in the load should not cause
not more than 3 percent in the weight of the pack prior to
sterilization and the pack should exhibit no wet spots.
6)
Certification Compliance Examination: Certifications, certified
test reports, or listing marks for codes and standards, as
applicable, should be examined and validated as proof of
compliance.
a)
Sterilizers should conform to the following standards:
-
American Society of Mechanical Engineers (ASME)
-
American National Standards Institute (ANSI)
-
American Society for Testing and Materials (ASTM)
-
National Fire Protection Association (NFPA)
-
United States Pharmacopoeial Convention, Inc.
b)
Conformance to these standards should be evidenced by seal,
label, stamp, or certified test reports.
11710-8
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