ISO 22442-3 PDF

It applies where required by the risk management process as described in ISO 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. This part of ISO does not cover the utilization of human tissues in medical devices. This part of ISO does not specify a quality management system for the control of all stages of production of medical devices. 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.

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Daishicage Take the smart route to manage medical device compliance. The quality management system elements that are required by this part of ISO can form part of a quality management system conforming to ISO Isoo this reason, the following need to be considered in particular:. 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.

Similar principles may apply to TSE agents. Attention is drawn the standards for quality management systems see ISO that control all stages of production or reprocessing of medical devices. It is not a requirement of this part of BS EN Isl to have a full quality management system during manufacture, but it does specify requirements for some of the elements of a quality management system. 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.

Click to learn more. Historically there have been many instances of unknown or unsuspected viral contamination during manufacture. Saudi Standards, Metrology and Quality Organization. The guidance given in this standard is not normative and is not provided as a checklist for auditors. Conventional processes used for sterilization, when used for the treatment isk animal tissues for medical devices, have not been shown to be completely effective in inactivating the causative agents of transmissible spongiform encephalopathy.

Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden. Please download Chrome or Firefox or view our browser tips. 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. Learn more about the cookies we use and how to change your settings.

You may find similar items within these categories by selecting from the choices below:. Ministry of Commerce and Industry. Worldwide Standards We can source any standard from anywhere in the world. 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.

Find Similar Items This product falls into the following categories. You can buy this standard from any national standardization body. Accept and continue Learn more about the cookies we use and how to change your settings. Requirements for regulatory purposes. It does not cover other transmissible and non-transmissible agents.

Medical devices utilizing animal tissues and their derivatives — Part 3: This part of ISO does not specify a quality management system for the control of all stages of production of medical devices. The files of this standards is not available in the store right now.

It applies where required by the risk management process described in ISO NOTE 3 It is not a isso 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. Search all products by. We use cookies to make our website easier to use and to better understand your needs.

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 Internet Explorer 8 or Sio 3. 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 is of all stages of production of medical devices.

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It specifies, in conjunction with ISO , a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO , and expected medical benefit as compared to available alternatives. This part of ISO is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as a contamination by bacteria, moulds or yeasts; b contamination by viruses; c contamination by agents causing Transmissible Spongiform Encephalopathies TSE ; d material responsible for undesired pyrogenic, immunological or toxicological reactions. For parasites and other unclassified pathogenic entities, similar principles can apply. ISO does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an International Standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.

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