11137 iso

The ISO standard also provides information and guidance on equipment, irradiation compatible materials, Dose setting methods and dosimetric aspects for Gamma, E-Beam and X-Ray sterilization. For example the standard explains that all plastics can be classified as materials whose molecules either i predominantly degrade with irradiation or ii predominantly crosslink with irradiation. The latter types tend to have higher radiation stability.

Life Science Outsourcing prides itself on our role as partners in bringing medical innovations to life. That partnership forms the foundation of what sets us apart. ISO Some specific guidelines for material selection are: Aromatic materials are more stable than aliphatic materials High levels of antioxidants help radiation stability.

Abstract Preview ISO specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. ISO does not: specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease; detail specified requirements for designating a medical device as sterile; specify a quality management system for the control of all stages of production of medical devices; specify requirements for occupational safety associated with the design and operation of irradiation facilities; specify requirements for the sterilization of used or reprocessed devices.

Status : Published. Publication date : This standard contributes to the following Sustainable Development Goal :. CHF Buy. People also bought ISO Sterilization of health care products. ISO Sterilization of health care products.

Part 3: Guidance on dosimetric aspects of development, validation and routine control. This standard contributes to the following Sustainable Development Goal :. CHF Buy. People also bought ISO Sterilization of health care products. Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

ISO Sterilization of health care products. Part 3: Guidance on dosimetric aspects of development, validation and routine control. Life cycle Previously Withdrawn. Final text received or FDIS registered for formal approval.