Radiation sterilization—computer evaluation of ISO 11137 dose setting method 1 and ISO/TR 13409 method for substantiation of 25 kGy

Author:

Aoshuang Yan,Tallentire Alan

Publisher

Elsevier BV

Subject

Radiation

Reference5 articles.

1. ANSI/AAMI Standard 32, 1991. Guideline for gamma radiation sterlization

2. Davis, K.W., Strawderman, W.E., Masefield, J., Whitby, J.L., 1981. DS gamma radiation dose setting and auditing strategies for sterilizing medical devices. Sterilization of Medical Products. Multiscience Publications Ltd, Montreal, Canada, p. 34

3. The rationale and a computer evaluation of a gamma irradiation sterilization dose determination method for medical devices using a substerilization incremental dose sterility test protocol;Davis;J. Appl. Bacteriol.,1984

4. ISO Standard 11137, 1995. Sterilization of health care products—Requirement for validation and routine control—Radiation sterilization

5. ISO Technical Report 13409, 1996. Sterilization of health care products—Radiation sterilization—Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches

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