Optimizing EtO sterilization

Medical Device and Diagnostic Industry

Volumn 23, Issue 8, 2001, Pages 70-79

  Sordellini, Paul J ^a   Bonanni, Frank R ^a   Fontana, Gregory A ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

EID: 58549111458     PISSN: 0194844X     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (7)

1. Paul J Sordellini, "Speeding EtO-Sterilized Products to Market with Parametric Release," Medical Device & Diagnostic Industry 19, no. 2(1997): 67-80.
2. Cheryl A Boyce, "Guidance on the New QS Regulation Calibration Requirements," The Validation Consultant 4, no. 7 (1997): 12-14.
3. Code of Federal Regulations, 21 CFR Part 820, "Quality System Regulations."
4. Medical Devices-Validation and Routine Control of Ethylene Oxide Sterilization, AAMI/ANSI/ISO 11135 (Arlington, VA: AAMI, 1994).
5. AAMI/ANSI/ISO 11135, (Arlington, VA: AAMI, 1994), sects. 5.3.4, 5.5.2.1, and 5.5.2.2.
6. Ethylene Oxide Sterilization Equipment, Process Considerations, and Pertinent Calculations, AAMI TIR No. 15-1997 (Arlington, VA: AAMI, 1998).
7. AAMI TIR No. 15-1997(Arltngton, VA: AAMI, 1998), sect. 6.0.