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(Specification)Standard Performance and Safety Specification for Cryosurgical Medical Instruments (Withdrawn 2011)
Standard Performance and Safety Specification for Cryosurgical Medical Instruments (Withdrawn 2011)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
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-
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
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
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.
Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
This specification is under the jurisdiction of ASTM Committee F04 on 4th Floor, New York, NY 10036. DOI: 10.1520/F0882-84R02.
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.
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.
F882 – 84 (2002)
2.4 International ElectroTechnical Commission (IEC) 3.1.13 Dewar withdrawal device—a device specifically de-
Document: signed to attach to a dewar for proper and safe removal of its
IEC 601-1 1977 contents.
2.5 Compressed Gas Association Document: 3.1.14 disposable—any device which is designated to be
CGA V-1 1977 discarded after use.
2.6 FDA Document: 3.1.15 inflammatory response—irritation of tissue cells as a
21CFR801: Labeling Specifications result of using a cryosystem.
2.7 NBS Document: 3.1.16 mechanical integrity—the ability of all components
Table IPTS-68 NBS Monograph 125 of a cryosystem to withstand the pressures and temperatures
that may be encountered during use as recommended by the
3. Terminology
manufacturer.
3.1 Definitions:
3.1.17 open cryotip—a device specifically designed to ap-
3.1.1 closed cryotip—a hollow, closed end usually shaped ply the cryogen directly to the target tissue.
to fit a particular anatomical site where the cryogen cools the
3.1.18 target tissue—the specific anatomical area intended
external surface which is applied to the target tissue. to be treated.
3.1.2 closed cryotip reference temperature—the average of 3.1.19 thermal insulation—a material or technique, or both,
the minimum/maximum cycle temperature variation at the end used to prevent unintended cryonecrosis, inflammatory re-
of the freeze cycle. sponses, or cryoadhesion to nontarget tissue.
3.1.3 compressed gas cylinder—a container that is specifi- 3.1.20 thermocouple—a junction of two dissimilar metals
cally designed to store a gas or liquid under elevated pressure that produce an output voltage proportional to the temperature
conditions. of the junction. When used in conjunction with a cryometer(s),
3.1.4 compressed gas cylinder connector—a device specifi- the output is directly correlated to the temperature to which the
cally designed to attach to a cylinder for proper and safe sensing junction is exposed.
removal of its contents. 3.1.21 tractive forge—the cryoadhesive attraction between
3.1.5 cryoadhesion—cryotip attachment to target tissue. the cryotip and the target tissue.
3.1.6 cryogen—asubstanceusedtoobtainreducedtempera- 3.1.22 worst case conditions—the maximum pressures or
tures. Cryogens are usually classed by their boiling points. The temperatures, or both, a cryosystem may encounter when used
most common cryogens and their respective boiling points are according to the manufacturer’s instructions.
as follows:
4. Conformance
Cryogen Boiling Point at S.T.P., °C
Freon 12 −29.8
4.1 Presently, this specification is voluntary and not man-
Freon 22 −49.8
dated by law. A manufacturer may label his product as
Carbon Dioxide (CO ) −78.6
conforming to these standards only if the product indeed meets
Nitrous Oxide (N O) −88.5
Liquid Nitrogen (LN ) −195.8
2 the requirements of this specification.
3.1.7 cryometer—a device for measuring low tempera-
5. Cryosystem Performance and Reproducibility
ture(s) when used with a temperature sensor such as a
Requirements
thermocouple.
5.1 The purpose of these requirements is to ensure that a
3.1.8 cryonecrosis—destruction of tissue cells using a cryo-
cryosystem of the same design or accessories, or both, shall
system.
meet the minimum performance and reproducibility require-
3.1.9 cryoprobe—theinstrumentusedtodeliverthecryogen
ments as originally designed. The cryosystem and accessory
to the cryotip or open tip. For a cryotip, a cryoprobe also
requirements shall not vary from procedure to procedure
directs the cryogen away from the target tissue.
provided they are used and maintained according to the
3.1.10 cryosystem—all parts of a system excluding the
manufacturer’s recommendations.
cryogen and its container, unless supplied by the manufacturer,
5.2 Closed Cryotip Temperature Reproducibility:
that is designed to apply or use a cryogen.
5.2.1 Cryosystem requirements are divided into three pri-
3.1.11 defrost—the ability to return the cryotip to ambient
mary categories in accordance with their clinical application:
temperature.
cryonecrosis, inflammatory response, and cryoadhesion. The
3.1.12 Dewar—a vacuum insulated container that is specifi-
manufacturer’s test procedures must be categorized into these
cally designed to store a liquid cryogen.
groups and tested accordingly.
5.2.2 All cryosystems manufactured with closed cryotips of
Available from the International Electro-Technical Commission (IEC), Com-
the same model, temperature sensing or nontemperature sens-
mittee 62D, Rue de Varembe, CH-1211, NIOSH, Geneva 20, Switzerland.
ing, shall meet the requirements of Table 1.
Available from Compressed Gas Association (CGA), 1725 Jefferson Davis
5.2.3 Test Method—See Section 11.
Hwy., Suite 1004, Arlington, VA 22202-4102.
5.3 Closed Cryotip Tractive Force:
Available from American Association of State Highway and Transportation
Officials (AASHTO), 444 N. Capitol St., NW, Suite 249, Washington, DC 20001.
5.3.1 All cryosystems specifically designed for cryoadhe-
Available from the Food and Drug Administration (FDA), Bureau of Medical
sion shall be capable of attaching to, lifting, and holding a
Devices, 8757 Georgia Ave., Silver Spring, MD 20910.
minimum weight of 60 g for a minimum of 45 s.
Available from the National Bureau of Standards-Monograph 125, Gaithers-
burg, MD 10877. 5.3.2 Test Method—See Section 12.
F882 – 84 (2002)
TABLE 1 Time and Temperature Requirements
statement shall appear in the instrument’s instruction manual
Freeze Mode Cryotip Temperature and, if possible, on sections of the instrument that become 0°C
Manufacturers
Duration Reproducibility (°C)
or colder.
Specified In-
Range Range
tended Time per Cycle
6.2.2 A cryosystem designed to spray a cryogen onto a
0to −100.1
Use (s)
−100°C to −200°C
target tissue must have a disclosure statement warning the user
Cryonecrosis 180 65 610
to provide adequate protection to himself and the patient due to
Inflammatory Response 30 65 610
excess or residual cryogen droplets or mist.
Cryoadhesion 30 610 610
6.2.3 Adisclosure statement shall be required that states the
normal operating pressure at +20°C, the boiling point, and the
type of cryogen for which the instrument is designed.
6.2.4 Sterilization—A disclosure statement that states ex-
5.4 Monitoring Devices:
actly what items of the cryosystem and its accessories can be
5.4.1 Cryogen Monitors, Regulators, and Gages—Cryogen
sterilized and the recommended sterilization procedures shall
monitors include any instrument, device, or accessory intended
be included with each cryosystem.
to display or control any cryogen parameter. The cryogen
monitors include, but are not limited to, pressure gages, 6.2.5 Presterilized Cryosystem—A disclosure statement
shall be included with each presterilized cryosystem. This
pressure regulators, flow gages, and flow regulators.
statement shall include the following information: (1) the
5.4.1.1 Pressure gages on all cryosystems shall meet or
device is sterile, (2) the expiration date of sterilization, and (3)
exceed the ANSI Specification B 40.1.
notes of caution concerning means of shipping, storage, and
5.4.1.2 Cryogen monitors shall be compatible with the type
use of the instrument.
of cryogen employed and be of such design and construction to
6.2.6 All ac powered cryosystems and accessories shall be
display or control the cryogen safely.
prominently labeled “Danger-Explosion Hazard. Do Not Use
5.4.1.3 The manufacturer shall assure the user that the
in Presence of Flammable Anesthetics.”
safety, performance, and reproducibility of a cryosystem will
6.2.7 TissueTemperatureMonitors—Thefollowingdescrip-
be maintained at the maximum error points of the cryogen
tion and specifications shall be included in the disclosure
monitor(s). See disclosure requirement in 6.2.10.
statement for tissue temperature monitors.
5.4.2 Temperature Monitors, Cryotip—Temperature moni-
6.2.7.1 Type of cryometer (analog, digital, recorder),
tors include, but are not limited to: analog cryometers, digital
6.2.7.2 Temperature range: minimum to maximum,
cryometers,chartrecorders.Athermocoupleismostcommonly
6.2.7.3 Type of thermocouple (for example, Type “T”),
used as the temperature sensor.
6.2.7.4 Temperature limits for storage, shipping, and opera-
All cryotip temperature monitor(s) shall be representative of
the temperature of the cryotip when tested using the simulated tion, and
tissue model. The following requirements shall be applied to 6.2.7.5 Power requirements.
cryosystems containing cryotip temperature monitors:
6.2.8 Cryogen Use, Handling, and Storage—The manufac-
turer shall disclose all safety requirements for use, handling,
Temperature Range °C
0 to − 100 −100.1 to − 200
and storage of cryogens as recommended by the cryogen
65° 610°C
supplier.
5.4.3 Temperature Monitors, Tissue Temperature—All
6.2.9 Optimum Operating Pressure—The optimum operat-
cryosystems of accessories with tissue temperature monitors
ing pressure for each open cryotip shall be disclosed to
thatuseaninvasiveonnoninvasivetechniquetomonitoractual
maximize control and where appropriate minimize liquid run
tissue temperature shall adhere to the requirements listed in
off.
5.4.2.
6.2.10 Cryogen Containers—The manufacturer shall rec-
ommendorsupplycontainersdesignedforthespecificcryogen
6. Disclosure, Labeling, and Documentation
employed.
Requirements
6.2.11 CryogenMonitors,RegulatorsandGages—Adisclo-
sure statement is required stating the recommended operating
6.1 These requirements are intended to ensure a manufac-
pressures, the minimum and maximum pressure limits, the
turers’ written dissemination of all necessary information that
optimum cryogen flows, the pressure or flow gage accuracy,
allow a user to determine properly a cryosystem’s (and its
and the accuracy and reproducibility of all regulators used in a
accessories) operation, application, and limitation. These dis-
cryosystem or accessory, where applicable.
closure, labeling, a
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