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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The guidance given in this standard is not normative and uso not provided as a checklist for auditors. For this reason, the following need 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.

Medical devices utilizing animal tissues and their derivatives — Part 3: Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden.

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You may experience issues viewing this site in Internet Explorer 9, 10 or Requirements for regulatory purposes. It applies where required by the risk management process as described in ISO For this reason, the following need to be considered in particular: Learn more about the cookies we use and how to change your settings.

Saudi Standards, Metrology and Quality Organization. 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 isk management system. Search all products by. Historically there have been many instances of unknown or unsuspected viral contamination during manufacture.

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Your basket is empty. The standards for quality ieo 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.

You can buy this standard from any national standardization body. You may find similar items within these categories by selecting from the choices below:. Click to learn more. We use cookies to make our website easier to use and to better understand your needs.

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. Accept and continue Learn more about the cookies we use and how to change your settings.

It does not cover other transmissible and non-transmissible agents.

GSO ISO – Standards Store – GCC Standardization Organization

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. It is not a requirement of this part of BS EN 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.

It does not cover other transmissible and non-transmissible agents. The files of this standards is not available in the store right now. This part of Iao does not specify a quality management 24242-3 for the control of all stages of production of medical devices.

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. Similar principles may apply to TSE agents. Attention is drawn to the standards for quality management systems see ISO that control all stages of production or reprocessing of medical devices.

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Worldwide Standards We can source any standard from anywhere in the world. The quality management system elements that are required by this part of ISO can form part of a quality management system conforming to Lso Conventional processes used for sterilization, when used for 224423- treatment of animal tissues for medical devices, have not been shown to be completely effective in inactivating the causative agents of transmissible spongiform encephalopathy.

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. Medical devices utilizing animal tissues and their derivatives.

BS EN ISO 22442-3:2007

Ministry of Commerce and Industry. Take the smart route to manage medical device compliance. This part of BS EN ISO 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.

This part of ISO does not cover the utilization of human tissues in medical devices.