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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It does not cover other transmissible and non-transmissible agents. Medical devices utilizing animal tissues and their derivatives — Part 3: Attention is drawn to the standards for quality management systems see ISO that control all stages of production or reprocessing of medical devices. This part of ISO does not specify a quality management system for the control of all stages of production of medical devices. Your basket is empty. For the safety of medical devices there are two complementary approaches see BS EN ISO that can be adopted 224423- control the potential contamination of tissues.

This part of ISO does not cover the utilization of human tissues in medical devices. You may find similar items within these categories by selecting from the choices below:.

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. For this reason, the following need to be considered in particular:. It applies where required by the is management process as described in ISO Click to learn more.

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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, evaluation of the manufacturing process can provide a measure of confidence that a wide number of viruses, including unknown pathogenic viruses are eliminated. Conventional processes used for sterilization, when used for the treatment of animal tissues for medical jso, have not been shown to be completely effective in inactivating the causative agents of transmissible spongiform encephalopathy.

Accept and continue Learn more about the cookies we use and how to change your settings. Attention is drawn to the standards for quality management systems see BS EN ISO that control 224422-3 stages of production or reprocessing of medical devices. Similar principles may apply to TSE agents. We use cookies to make our website easier to use and to better understand your needs. Find Similar Items This product falls into the following categories. Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden.

The guidance given in this standard is not normative and is ido provided as a checklist for 22442–3.

GSO ISO – Standards Store – GCC Standardization Organization

You 224442-3 experience issues viewing this site in Internet Explorer 9, 10 or Worldwide Standards We can source any standard from anywhere in the world. Search all products by. Conventional processes used for sterilization, when used for jso treatment of animal tissues for medical devices, have not been shown to be completely effective in inactivating the causative agents of transmissible spongiform encephalopathy.

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The files of this standards is not available in the store right now. 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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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.

Saudi Standards, Metrology and Quality Organization.

BS EN ISO 22442-3:2007

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. It does not cover other transmissible and non-transmissible agents. Ministry of Commerce and Industry. 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.

Requirements for regulatory purposes. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

Take the smart route to manage medical device compliance. Medical devices utilizing animal tissues and their derivatives. Historically there have been many instances of unknown or unsuspected viral contamination during manufacture.

For this reason, the following need to be considered in particular: You can buy this standard from any national standardization body.