ASTM F882-84(2002)
(Specification)Standard Performance and Safety Specification for Cryosurgical Medical Instruments (Withdrawn 2011)
Standard Performance and Safety Specification for Cryosurgical Medical Instruments (Withdrawn 2011)
SCOPE
1.1 This specification covers 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 of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
WITHDRAWN RATIONALE
This specification covers 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.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this performance and safety specification was withdrawn in July 2011 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F882 – 84 (Reapproved 2002)
Standard Performance and Safety Specification for
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Cryosurgical Medical Instruments
ThisstandardisissuedunderthefixeddesignationF882;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
This standard has been approved for use by agencies of the Department of Defense.
INTRODUCTION
This performance and safety specification was developed by Task Force F04.08 on Cryosurgical
Medical Instruments.
This specification is intended to provide the user of Cryosurgical Medical Instruments with the
assurance that the equipment will meet or exceed all safety and performance levels established by this
document as claimed by the manufacturer. This is predicated on the requirements that the equipment
is operated according to the manufacturer’s recommendations.
Since, in the pursuit of improved health care and reduced medical costs, the medical industry is
required to be innovative and dynamic, this standard must be capable of being upgraded in a swift and
efficient manner. All inquiries regarding this standard should be addressed to: Committee F04 Staff
Manager, ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428.
1. Scope 1.5 Cryosurgical medical instruments are used to produce
cryonecrosis, inflammatory response, or cryoadhesion.
1.1 This specification covers standards a manufacturer shall
1.6 Monitoring the progress of treatment during application
meet in the designing, manufacturing, testing, labeling, and
is sometimes very important. Such monitoring is done by
documenting of cryosurgical medical instruments, but it is not
accessories that indicate the temperature of the cryotip or the
to be construed as production methods, quality control tech-
target area being frozen. The temperature of the tissue may be
niques, or manufacturer’s lot release criteria, or clinical rec-
measured directly (for example, by a thermocouple). These
ommendations.
accessories are also covered by this specification.
1.2 This specification represents the best currently available
1.7 The following precautionary caveat pertains only to the
test procedures at this time and is a minimum safety and
Test Method portion, Sections 8 through 13, of this specifica-
performance standard.
tion: This standard may involve hazardous materials, opera-
1.3 This specification covers only those cryosurgical de-
tions, and equipment. This standard does not purport to
vices intended for use on humans or animals for therapeutic
address all of the safety concerns, if any, associated with its
purposes. This specification assumes the user is well-trained in
use. It is the responsibility of the user of this standard to
the procedures of cryosurgery and has the ability to determine
establish appropriate safety and health practices and deter-
if an abnormality is treatable by cryosurgery, particularly by
mine the applicability of regulatory limitations prior to use.
the type of equipment to be used.
1.4 Cryosurgical medical instruments produce low tempera-
2. Referenced Documents
tureseitherinsideacryoprobeordirectlyonthetargettissueby
2.1 ANSI Standard:
the principle of Latent Heat of Vaporization or the Joule-
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ANSI B40.1-1974 Use and Installation of Pressure Gauges
Thompson Effect, or both. The cryogen may be transported
2.2 ANSI/AAMI Document:
from the source as a liquid or a gas. These systems may be
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ANSI/AAMI SCL 12/78
closed or open depending on the application and cryogen. In
2.3 Canadian Standards Association (C.S.A.) Standard:
the open cryotip system, the cryogen is applied directly to the
4
C22.2-125 Electromedical Equipment 1973
target tissue, while in the closed cryotip system, the cryogen is
applied indirectly and is exhausted away from the target area.
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Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
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This specification is under the jurisdiction of ASTM Committee F04 on 4th Floor, New York, NY 10036. DOI: 10.1520/F0882-84R02.
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Medical and Surgical Materials and Devices and is the direct responsibility of Available from the Association for the Advancement of Medical Instrumenta-
Subcommittee F04.33 on Medical/Surgical Instruments. tion (AAMI). 1901 North Fort Myer Drive, Suite 602, Arlington, VA 22209.
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Current edition approved Sept. 11, 1984. Published February 1985. DOI: Available from the Canadian Standards Association (C.S.A), 173 Rexdale
10.1520/F0882–84R02. Blvd., Rexdale, Ontario M9W 1R3, Canada.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F882 – 84 (2002)
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