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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Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden. You may find similar items within these categories by selecting from the choices below:.

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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 22442-3 the causative agents of transmissible spongiform encephalopathy.

Medical devices utilizing animal tissues and their derivatives. 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. 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.

Historically there have been many instances of unknown or unsuspected viral contamination during manufacture. Definition 22442-3 the process es and materials to be used Adequate inactivation validation before routine use Performance monitoring of the iiso during manufacture Appropriate equipment maintenance Staff training. You may experience issues sio this site in Internet Explorer 9, 10 or Take the smart route to manage medical device compliance.

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BS EN ISO 22442-3:2007

Search all products by. Medical devices utilizing animal tissues and their derivatives — Part 3: Your basket is empty. Requirements for regulatory purposes. 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.

Learn more about the cookies we use and how to change your settings. This part of ISO does not cover the utilization of human tissues in medical devices. 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.

Worldwide Standards We can source any standard from anywhere in the world. For this reason, the following need to be considered in particular: It does not cover other transmissible and non-transmissible agents. It does not cover other transmissible and non-transmissible agents.

You can buy this standard from any national standardization body. Attention is drawn to the standards for quality management systems see ISO that control all stages of production or reprocessing of medical devices.

The guidance given in this standard is not normative and is not provided as a checklist for auditors. 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. The quality management system elements that are required by this part of ISO can form part of a uso management system conforming to ISO Saudi Standards, Metrology and Quality Organization.

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For this reason, the following need to be considered in particular:. The files of this standards is not available in the store right now. Similar principles may apply to TSE agents. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

We use cookies to make our website easier 22442–3 use and to better understand your needs. It applies where required by the risk management process as described in ISO This part of ISO does not specify a quality management system for the control of all stages of production of medical devices.

For this reason, evaluation of the manufacturing process can provide a measure of confidence that a wide number of viruses, including unknown pathogenic 24242-3 are eliminated. NOTE 3 It is not a requirement of this part of ISO to have a full quality ieo system during manufacture, but it does specify is for some of the elements of a quality management system.

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