Biomedical Engineering Reference
In-Depth Information
ISO 14937, `Sterilization of healthcare products ± general requirements for
characterization of a sterilizing agent and the development, validation and routine
control of a sterilization process for medical devices,' available at www.iso.org.
ISO 14971 (2000), `Medical devices ± application of risk management
to medical
devices,' available at www.iso.org.
ISO 11737-1 (2006), `Sterilization of medical devices ± microbiological methods ± Part
1: Determination of a population of microorganisms on products', available at
www.iso.org.
ISO 14160 (1998), `Sterilization of single-use medical devices incorporating materials of
animal origin ± Validation and routine control of sterilization by liquid sterilants',
available at www.iso.org.
ISO 22442-1 (2007), `Medical devices utilizing animal tissues and their derivatives ± Part
1: Application of risk management', available at www.iso.org.
ISO 22442-2 (2007), `Medical devices utilizing animal tissues and their derivatives ± Part
2: Controls on sourcing, collection and handling', available at www.iso.org.
ISO 22442-3 (2007), `Medical devices utilizing animal tissues and their derivatives ± Part
3: Validation of the elimination and/or inactivation of viruses and transmissible
spongiform encephalopathy (TSE) agents', available at www.iso.org.
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