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Medical devices utilizing animal tissues and their derivatives - Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes

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Medical devices utilizing animal tissues and their derivatives - Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes1 Scope This Technical Report offers suggestions for designing and conducting validation assays to help determine if processes used in the manufacture of medical devices derived from non viable animal tissues might serve to reduce the risk of iatrogenic transmission of transmissible spongiform encephalopathies (TSEs). The TSE removal methods used to process animal tissues should also reduce the risk of transmitting TSE infections via non viable

BS EN 15347 provides for a division of information between "Required Data"

This European Standard does not apply to latching mechanisms

NOTE 2 The limit of detection of most elements will be affected by their natural abundance

ISO 8 discusses information and documentation

it is not intended to imply that these subclauses can be implemented in the absence of the entire quality management system described in the standard

BS EN 62509 could be used in conjunction with IEC 62093

This International Standard specifies the types of test for fuel filters in accordance with their application

BS 4553-3 provides guidelines to manufacturers on how to use or thermosetting insulating cables for adequate performance in that application

upon the image reception area and thus to improve the contrast of the X-ray pattern

Any entity related to the food industry

users can develop and assess electrical cables for aircraft use to ensure conductor protection

6 Suppliers and partnerships

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