Kowalski J B, Tallentire A
Johnson & Johnson, New Brunswick, New Jersey, USA.
Med Device Technol. 2000 May;11(4):22-5.
Neither of the standards for the validation and routine control of sterilization of medical devices by ionizing radiation provides detailed guidance on how to substantiate a 25 kGy sterilizing dose. This article describes the basis of a new method for substantiating this dose and how the resulting procedure has been applied in practice.