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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Saudi Standards, Metrology and Quality Organization. Please download Chrome or Firefox or view our browser tips. Accept and continue Learn more about the cookies we use and how to change your settings. Find Similar Items This product falls into the following categories.

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. Requirements for regulatory purposes.

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.

Medical devices utilizing 224423 tissues and their derivatives — Part 3: The quality management system elements that are required by this part of ISO can form part of a quality management system conforming to ISO Your basket is empty.

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Historically there have been many instances of unknown or unsuspected viral contamination during manufacture. It does not cover other transmissible and non-transmissible agents. Take the smart route to manage medical device compliance.

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This part of ISO does not cover the utilization of human tissues in 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. 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. 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. Medical devices utilizing animal tissues and their derivatives.

This part of ISO does not specify a quality management system for the control of all stages of production of medical devices.

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Search all products by. Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden. You may experience issues viewing this site in Internet Explorer 9, 10 or For the safety of medical devices there are two complementary uso see BS EN ISO that can be adopted to control the potential contamination of tissues.

Click to learn more. Worldwide Standards We can source any standard from anywhere in the world. The files of this standards is not available in the store right now. You may find similar items within these categories by selecting from the choices 22442–3. The standards for quality management systems uso that, for certain processes used in manufacturing, the effectiveness of that process cannot be fully verified by subsequent inspection and testing of the product.

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BS EN ISO 22442-3:2007

Attention is drawn to the standards for quality management systems see ISO that control all stages of production or reprocessing of medical devices. It applies where required by the risk management process as described in ISO For this reason, the following need to be considered in particular:. This website is 22442-33 viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

You can buy this standard from any national standardization body. For this reason, the following need to be considered in particular: We use cookies to make our website easier to use and to better understand your needs.

The guidance given in this standard is not normative and is not provided as a checklist for auditors. 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.

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.

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

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