Radiation sterilization - Evaluation of a new approach for substantiation of 25 kGy

Radiation Physics and Chemistry

Volumn 58, Issue 1, 2000, Pages 77-86

  Kowalski, John B ^a   Aoshuang, Yan ^b   Tallentire, Alan ^c  

^a JOHNSON AND JOHNSON   (United States)

^b Beijing Radiation Application Research Center   (China)

^c Air Dispersions Ltd   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

IONIZING RADIATION; IRRADIATION; STANDARDS;

RADIATION STERILIZATION;

STERILIZATION (CLEANING);

ARTICLE; COMPUTER PROGRAM; IONIZING RADIATION; MICROORGANISM; RADIATION DOSE; RADIATION STERILIZATION; RADIOSENSITIVITY; STANDARD; TECHNIQUE; THEORETICAL STUDY;

EID: 0034013354     PISSN: 0969806X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0969-806X(99)00354-0     Document Type: Article

References (7)

1. Aoshuang Y., Tallentire A. Radiation sterilization - computer evaluation of ISO 11137 dose setting Method 1 and ISO/TR 13409 method for substantiation of 25 kGy. Radiat. Phys. Chem. 54:1999;83-94.
2. Davis K.W., Strawderman W.E., Whitby J.L. The rationale and computer evaluation of a gamma sterilization dose determination method for medical devices using a substerilization dose sterility test protocol. J. Appl. Bacteriol. 57:1984;31-50.
3. EN Standard 552, 1994. Sterilization of medical devices - Validation and routine control of sterilization by irradiation.
4. ISO Standard 11137, 1995. Sterilization of health care products - Requirements 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.
6. Kowalski J.B., Tallentire A. Substantiation of 25 kGy as a sterilization dose: a rational approach to establishing verification dose. Radiat. Phys. Chem. 54:1999;55-64.
7. Tallentire A. Radiation dose setting/substantiation methods: have we got it right? Morrissey R.F., Kowalski J.B. Sterilization of Medical Products. Vol. VII:1998;260-277 Polyscience Publications, Champlain, New York.