Links
• ISO 13485:2016: www.iso.org/st...
• ISO 14161:2009: Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results, www.iso.org/st...
• Medical Device Single Audit Program (MDSAP) Audit Approach: www.fda.gov/me...
o Chapter 3: Task 7
o Chapter 6: Tasks 4 and 9
• Sterilization: Monitoring, Centers for Disease Control and Preventive, www.cdc.gov/or...
• Biological Indicators, Steris Healthcare, www.steris.com...
Requirement name and location
Our requirement, Biological Indicators, is covered by ISO 13485 § 7.5.2 and 7.5.7. It has its own ISO standard ISO 14161:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
Biological Indicators in 5 words:
Most Difficult Microorganisms to Kill