ASTM-F882 1996

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F882-84(1996) Standard Performance and Safety Specification for Cryosurgical Medical Instruments

Published By	Publication Date	Number of Pages
ASTM	1996	7

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Category: ASTM

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Description

ASTM F882-84-Reapproved1996

Historical Standard: Standard Performance and Safety Specification for Cryosurgical Medical Instruments

ASTM F882

Scope

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

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents
2	Terminology Conformance Cryosystem Performance and Reproducibility Requirements
3	Disclosure, Labeling, and Documentation Requirements TABLE 1
4	Cryosystem Safety Requirements
5	Significance and Use Test Method for Mechanical Integrity Test Method for Determining Ambient Concentration of Nitrous Oxide FIG. 1 TABLE 2
6	Test Method for Determining Closed Cryotip Temperature Reproducibility Tractive Force Test Method FIG. 2
7	Test Method for Determining the Accuracy of Temperature Monitors (Cryotip and Tissue)

Additional information

Standard Title	F882-84(1996) Standard Performance and Safety Specification for Cryosurgical Medical Instruments
Published Code	ASTM
Publication Date	1996
Pages Count	7