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.

Author: Voodoolkree Mikarr
Country: Chile
Language: English (Spanish)
Genre: Software
Published (Last): 15 May 2004
Pages: 192
PDF File Size: 14.14 Mb
ePub File Size: 7.63 Mb
ISBN: 586-6-69064-145-4
Downloads: 42688
Price: Free* [*Free Regsitration Required]
Uploader: Gardazshura

Similar principles may apply to TSE agents. Your basket is empty. Worldwide Standards We can source any standard from anywhere in the world. We use cookies to make our website easier to use and to better understand your needs. Attention is drawn to the standards for quality management systems see ISO that control all stages of production or reprocessing of medical devices.

BS EN ISO 22442-3:2007

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.

Click io learn more. It does not cover other transmissible and non-transmissible agents. You may find similar items within these categories by selecting from the choices below:. For this reason, the following need to be considered in particular:. You can buy this standard from any national standardization body. Medical devices utilizing animal tissues and their derivatives. It is not a 224422-3 of this part of Lso 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.

  AIPHONE TD 1H B PDF

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.

Take the smart route to manage medical device compliance. For this reason, the following need to be considered in particular: This part of BS EN ISO does not cover the utilization of human tissues in medical devices, nor does it uso a quality management system for the control of all stages of production of medical devices.

The guidance given in this standard is not normative and is not provided as a checklist for auditors. It 224423- where required by the risk management process as described in ISO Medical devices utilizing animal 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 Is Similar Items This product falls into the following categories.

Search all products by. 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. You may experience issues viewing this site in Internet Explorer uso, 10 or Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden.

GSO ISO – Standards Store – GCC Standardization Organization

Requirements for regulatory purposes. Please download Chrome or Firefox or view our browser tips. 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 specify a quality management system for the control of all stages of production of medical devices.

  EOR 7550 PDF

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.

It does not cover other transmissible and non-transmissible agents. Learn 224423 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. Historically there have been many instances of unknown or unsuspected viral contamination during manufacture.

Saudi Standards, Metrology and Quality Organization. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Ministry of Commerce and Industry. 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.

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.