Field evaluations of the VDmax approach for substantiation of a 25kGy sterilization dose and its application to other preselected doses-Reference-Cited by-同舟云学术

Field evaluations of the VDmax approach for substantiation of a 25kGy sterilization dose and its application to other preselected doses

Author:

Kowalski John B,Herring Craig,Baryschpolec Lisa,Reger John,Patel Jay,Feeney Mary,Tallentire Alan

Publisher

Elsevier BV

Subject

Radiation

Reference7 articles.

1. AAMI TIR 27, 2001. Sterilization of health care products—Radiation sterilization—Substantiation of 25kGy as a sterilization dose—Method VDmax.

2. EN Standard 552, 1994. Sterilization of medical devices—Validation and routine control of sterilization by irradiation.

3. Gamma radiation sterilization practice in the US device industry;Hansen;Med. Device Diagn. Ind.,1994

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

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1. ANSI/AAMI/ISO 13004:2022; Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VD _max ^SD;ANSI/AAMI/ISO 13004:2022; Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD;2023-12-18

4. Sterilization of health care products—Radiation—Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VD_max^SD-S;AAMI TIR76:2021; Sterilization of health care products—Radiation—Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VDmaxSD-S;2021-03-31