It is most important that the objectives and potential uses of an. AAMI product standard or recommended practice are clearly understood. The objectives of. INTERNATIONAL. STANDARD. ISO. First edition. Medical devices utilizing animal tissues and their derivatives —. Part 3: Validation of the. Permission can be requested from either ISO at the address below or ISO’s .. ISO , Medical devices utilizing animal tissues and their.
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For the safety of medical devices there are two complementary approaches see BS EN ISO that can be adopted to control the potential contamination of tissues. Requirements for regulatory purposes. The standards for quality management systems recognize that, for certain processes used in manufacturing, the effectiveness of that process cannot be fully verified by subsequent inspection and testing of the product.
BS EN ISO 22442-3:2007
For this reason, the following need to be considered in particular:. Historically there have been many instances of unknown or unsuspected viral contamination during manufacture. For this reason, evaluation of the manufacturing process can provide a measure of confidence that a wide ios of viruses, including unknown pathogenic viruses are eliminated. Similar principles may apply to TSE agents. The guidance given in this standard is not normative and is not provided as a checklist for auditors.
It does not cover other transmissible and non-transmissible agents. Conventional processes used for sterilization, when used for the treatment of animal tissues for medical devices, have not been shown to be completely effective in inactivating the causative agents of transmissible spongiform encephalopathy. This part of BS EN 22424-3 does not cover the utilization of human tissues in medical devices, nor does it specify a quality management system for the control of all stages of production of medical devices.
It is not a requirement of this part of BS EN ISO to have a full quality management system during manufacture, lso it does specify requirements for some of the elements of ieo quality management system.
Attention is drawn to the standards for quality management systems see BS EN ISO that control all stages of production or reprocessing of medical devices. Worldwide Standards We can source any standard from anywhere in isi world. Learn more about the cookies we use and how to change your settings. Search all products by.
Find Similar Items This product falls into the following categories. You may find similar items within these categories by selecting from the choices below:. Click to learn more. For this reason, the following sio to be considered in particular: Definition of the process es and materials to be used Adequate inactivation validation before routine use Performance monitoring of the process during manufacture Appropriate equipment maintenance Staff training.
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Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden.