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Description of ASTM-F882 1996ASTM F882-84-Reapproved1996Historical Standard: Standard Performance and Safety Specification for Cryosurgical Medical InstrumentsASTM F882Scope 1.1 This specification establishes standards a manufacturer shall meet in the designing, manufacturing, testing, labeling, and documenting of cryosurgical medical instruments, but it is not to be construed as production methods, quality control techniques, or manufacturer's lot release criteria, or clinical recommendations. 1.2 This specification represents the best currently available test procedures at this time and is a minimum safety and performance standard. 1.3 This specification covers only those cryosurgical devices intended for use on humans or animals for therapeutic purposes. This specification assumes the user is well-trained in the procedures of cryosurgery and has the ability to determine if an abnormality is treatable by cryosurgery, particularly by the type of equipment to be used. 1.4 Cryosurgical medical instruments produce low temperatures either inside a cryoprobe or directly on the target tissue by the principle of Latent Heat of Vaporization or the Joule-Thompson Effect, or both. The cryogen may be transported from the source as a liquid or a gas. These systems may be closed or open depending on the application and cryogen. In the open cryotip system, the cryogen is applied directly to the target tissue, while in the closed cryotip system, the cryogen is applied indirectly and is exhausted away from the target area. 1.5 Cryosurgical medical instruments are used to produce cryonecrosis, inflammatory response, or cryoadhesion. 1.6 Monitoring the progress of treatment during application is sometimes very important. Such monitoring is done by accessories that indicate the temperature of the cryotip or the target area being frozen. The temperature of the tissue may be measured directly (for example, by a thermocouple). These accessories are also covered by this specification. 1.7 The following precautionary caveat pertains only to the Test Method portion, Sections 8 through 13, of this specification: This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Keywords Cryosurgical medical instruments; Instruments; Neurosurgical medical devices/applications; Safety precautions-medical materials/applications; cryosurgical medical instruments, performance/safety spec ICS Code ICS Number Code n/a DOI: 10.1520/F0882-84R96 This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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