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LEARNING CENTER
STERILIZATION VALIDATIONS: References

Sterilization of health care products—Radiation—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices, ANSI/AAMI/ISO 11137-1:2006

Sterilization of Health Care Products—Radiation-Part 2: Establishing the sterilization dose, ANSI/AAMI/ISO 11137-2:2006

Sterilization of Health Care Products—Radiation-Part 3: Guidance on dosimetric aspects, ANSI/AAMI/ISO 11137-3:2006

Sterilization of Health Care Products—Radiation-Substantiation of a selected sterilization dose-Method VDmax, AAMI TIR 33:2005

Sterilization of Health Care Products—Radiation Sterilization—Selection of a Sterilization Dose for Single Production Batch, ISO/TR No.15844:1998

Medical devices—Validation and routine control of ethylene oxide sterilization, AAMI/ISO 11135:1994 (new draft in progress)

Sterilization of Health Care Products—Radiation Sterilization—Product Families, sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits, ANSI/AAMI/ISO 15843:2000

Process Development and Performance Qualification for ethylene oxide sterilization – Microbiological Aspects, AAMI TIR 16:2000

Biological evaluation of medical devices—Part 7:  Ethylene oxide sterilization residuals, ANSI/AAMI/ISO 10993-7:1995/(R)2001

Sterilization of medical devices—Microbiological methods, Part 1:  Determination of a population of microorganisms on products, ANSI/AAMI/ISO 11737-1:2006

Sterilization of medical devices—Microbiological methods, Part 2:  Tests of sterility performed in the validation of a sterilization process, ANSI/AAMI/ISO 11737-2:2009

Sterilization of medical devices—Microbiological methods, Part 3:  Guidance on evaluation and interpretation of bioburden data, ANSI/AAMI/ISO 1737-3:2004

 

 
 
 
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