In article <mignatz-2212950000580001 at mjmiller.roc.servtech.com>,
mignatz at mjmiller.roc.servtech.com (Dr. Michael J. Miller) writes:
>>Unless you are working on humans in a clinical or hospital setting,
don't
worry about sterility assurance levels, spore log kill, Fo values, etc.
If you are, then you should be following the guidelines the hospital uses
for sterilization of medical devices as per AAMI.<<
I think AAMI has good standards, see:
1. The easiest book to find might be: Seymour S. Block _Disinfection,
Sterilization, and Preservation_. I have the 4th edition.
2. The United States Pharmacopeia (USP) 23 this outlines some of the
US-FDA regulations.
3. The PDA (Perenteral Drug Association) published monograph TM #1.
4. Assocoation for the Advancement of Medical Instrumentation (AAMI)
published sterilization of health care products.
BTW: What is the FDA vs. J&J status on the Cidex claims problem? Those
two have been fighting for years over efficacy.
