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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For this reason, the following need to be considered in particular:. We use cookies to make our io easier to use and to better understand your needs. Historically there have been many instances of unknown or unsuspected viral contamination during manufacture. Medical devices utilizing animal tissues and their derivatives. You may find similar items within these categories by selecting from the choices below:.

Worldwide Standards We can source any standard from anywhere in the world. Saudi Standards, Metrology and Quality Organization.

Attention is drawn to the standards for quality management systems see ISO that control all stages of production or reprocessing of medical devices.

Requirements for regulatory purposes. Search all products by. Attention is drawn to the standards for quality management systems see BS Isp ISO that control all stages of production or reprocessing of medical devices. It does not cover other transmissible and non-transmissible agents. 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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Take the smart route to manage medical device compliance. Medical devices utilizing animal tissues and their derivatives — Part 3: Click to learn more. Isk 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.

Learn more about the cookies we use and how to change your settings. It does not cover other transmissible and non-transmissible agents. NOTE 3 It 22442-3 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. Find Similar Items This product falls into the following categories.

For this reason, evaluation of the manufacturing process can provide a measure of 22442-3 that a wide number of viruses, including unknown pathogenic viruses are eliminated. The quality management 22424-3 elements that are required by this part of ISO can form part of a quality management system conforming to ISO 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 website is best viewed with browser version of up to Microsoft Jso Explorer 8 or Firefox 3. Ministry of Commerce and Industry. You may experience issues viewing this site in Internet Explorer 9, 10 or For the safety of medical devices there are sio complementary approaches see BS EN ISO that can be adopted to control the potential contamination of tissues.

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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.

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Similar principles may apply to TSE agents. 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. Accept and continue Learn more about the cookies we use and how to change your settings. Please download Chrome or Firefox or view our browser tips. You can buy this standard from any national standardization body.

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 2244-23 transmissible spongiform encephalopathy.

BS EN ISO 22442-3:2007

Your basket is empty. 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. Isl applies where required by the risk management process as described in ISO This part of ISO does not cover the utilization of human tissues in medical devices.

For this reason, the following need to be considered in particular: