ISO 22442-3 PDF
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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BS EN ISO 22442-3:2007
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.
You can buy this standard from any national standardization body. This part of ISO does not cover the utilization of human tissues in medical devices. The standards for quality management ixo 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. Your basket is empty.
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. You may experience issues viewing this site in Internet Explorer 9, 10 or Worldwide Standards We can source any standard from anywhere in the world. NOTE 3 It is not a requirement of this part of ISO to have a full quality management system during manufacture, but it does specify requirements for some of the elements of a quality management system.
You may find similar items within these categories by selecting from the choices below:. Conventional processes used for sterilization, when used for the treatment of animal tissues for medical devices, have not been shown isp be completely effective in inactivating the causative agents of transmissible spongiform encephalopathy.
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.
For this reason, evaluation of the manufacturing process can provide a measure of confidence that a wide number of viruses, including unknown pathogenic viruses are eliminated. The files of this standards is not available in the store right now. Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden. Learn more about the cookies we use and how to change your settings.
Find Similar Items This product falls into the following categories. The quality management system elements that are required by this part of ISO can form part of a quality management system conforming to ISO For this reason, the ido need to be considered in particular:. Io applies where required by the risk management process as described in ISO 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.
For this reason, the following need to be considered in particular: Medical devices utilizing animal tissues and their derivatives. It does not cover other transmissible and non-transmissible agents. Take the smart route to manage medical device compliance. This part of ISO does not specify a quality management system for the control of all stages of production of medical devices. Please download Chrome or Firefox or view our browser tips.
GSO ISO – Standards Store – GCC Standardization Organization
Historically there have been many instances of unknown or unsuspected viral contamination during manufacture. Attention is drawn to the standards for quality management systems see ISO that control all stages of production or reprocessing of medical devices. Similar principles may apply to TSE agents. Accept and continue Learn more about the cookies we use and how to change 224442-3 settings.
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