YY 0678-2008 PDF in English
YY 0678-2008 (YY0678-2008) PDF English
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Standard performance and safety specification for cryosurgical medical instruments
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YY 0678-2008: PDF in English YY 0678-2008
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PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.60
C 37
Standard Performance and Safety Specification
for Cryosurgical Medical Instruments
(ASTM F 882-84[Reapproved 2002], MOD)
ISSUED ON. OCTOBER 17, 2008
IMPLEMENTED ON. JUNE 1, 2010
Issued by. China Food and Drug Administration
Table of Contents
1 Scope ... 4
2 Normative References ... 4
3 Terms and Definitions ... 5
4 Cryosystem Performance and Reproducility Requirements ... 7
5 Disclosure, Labeling, and Documentation Requirements ... 10
6 Cryosystem Safety Requirements ... 14
Foreword
This Standard modifies and adopts ASTM F 882-84 (Reapproved 2002) “Performance
and Safety Cryosurgical Medical Instruments”.
The differences between this Standard and ASTM F 882-84 (Reapproved 2002) are
as follows. Delete the contents such as continuous leakage current, protection against
combustibility anesthesia gas mixture ignition danger, and determining temperature
monitor (cryotip and tissue) accurateness.
This Standard was proposed by and shall be under the jurisdiction of Hangzhou
Medical Appliance Quality Supervision Testing Center of China State Food and Drug
Administration.
Drafting organization of this Standard. Hangzhou Medical Appliance Quality
Supervision Testing Center of China State Food and Drug Administration
Chief drafting staffs of this Standard. Sun Yu, Du Long, Ye Yue Shun, Fang Le, Han
Jiancheng, and Ma li.
Standard Performance and Safety
Specification for Cryosurgical Medical
Instruments
1 Scope
This Standard specifies the basic requirements that cryosurgical medical instrument in
refrigeration system shall meet in the performance, reproducibility, publication,
labelling, documentation, and safety aspects.
The cryosurgical medical instrument referred in this Standard adopts the principle of
Latent Heat of Vaporization or the Joule-Thompson Effect, produces low temperature
in cryotip rod or directly to the target tissue, so as to produce cryonecrosis,
inflammatory response or cryoadhesion.
If, during the application, cryosurgical medical instrument utilizes displayable cryotip
or accessories at cryogen area temperature to monitor the treatment process, the
requirements of this Standard are applicable to these accessories.
2 Normative References
The following normative documents contain provisions which, through reference in
this text, constitute the provisions of this Standard. For dated references, subsequent
amendments (excluding corrigendum) or revisions of these publications do not apply.
However, all parties who enter into an agreement according to this Standard are
encouraged to study whether the latest editions of these documents are applicable.
For undated references, the latest editions of the normative documents referred to
applies.
GB/T 1226-2001 General Pressure Gauge
GB 9706.1 Medical Electrical Equipment - Part 1. General Requirements for
Safety (GB 9706.1-2007, IEC 60601-1.1988, IDT)
GB 15382-1994 General Technique Specifications for Cylinder Valves
Safety Inspection Regulations for Gas Cylinders, AQSIQ Decree No. 46
3 Terms and Definitions
For the purpose of this Standard, the following terms and definitions apply.
3.1 closed cryotip
a hollow, closed end usually shaped to fit a particular anatomical site where the
cryogen cools the external surface which is applied to the target tissue.
3.2 open cryotip
a device specifically designed to apply the cryogen directly to the target tissue.
3.3 cryoprobe
the instrument used to deliver the cryogen to the cryotip or open tip. For a cryotip, a
cryoprobe also directs the cryogen away from the target tissue.
3.4 cryosystem
all parts of a system excluding the cryogen and its container, unless supplied by the
manufacturer, that is designed to apply or use a cryogen.
3.5 compressed gas cylinder
a container that is specifically designed to store a gas or liquid under elevated
pressure conditions.
3.6 compressed gas cylinder connector
a device specifically designed to attach to a cylinder for proper and safe removal of its
contents.
3.7 Withdrawal device
connected device specially designed to make the cryogen in the container be
released as required.
3.8 cryogen
a substance used to obtain reduced temperatures.
Note. Cryogens are usually classed by their boiling points. The most common cryogens
and their respective boiling points are as follows.
Cryogen Boiling Point at S.T.P.,°C
Freon 22 −49.8
Carbon Dioxide (CO2) −78.6
water in a standard 1000 mL beaker. The water shall be maintained at
30°C±2°C by a constant temperature bath. The water in the beaker shall
not be circulated artificially during the actual test.
- Fast thermal thermocouple sensor.
- Temperature indicator or chart recorder.
- Other components, to make the cryosystem functional in accordance with
the manufacturer’s operational instructions.
b) Sampling.
- For limited production or a unique cryosystem, perform and record a series
of three freeze modes.
- For cryosystems of the same model, test and record three individual
systems.
c) Procedure.
- Attach the thermocouple sensor to the therapeutic surface of the cryotip as
determined by the manufacturer.
- Immerse the closed cryotip into the simulated tissue model in a way which
stimulates the intended application as determined by the manufacturer.
- Follow all parameters as described in the manufacturer’s operational
instructions to make cryosystem functional.
- Allow the cryotip to defrost between cycles.
- Include disposable devices.
- A pre-cycle for the cryosystems to normalize operating conditions is
permitted.
- Calculate the reference temperature and limits of deviation from the
recorded data.
d) Conformance.
Conformance with the requirements shall be checked by comparison of the
deviation between the closed cryotip reference temperature and Table 1.
4.3 Tractive Force of Closed Cryotip
All the Cryosystem specially designed for cryoadhesion shall be able to lift weight of
60g at least in adhesion for at least 45 minutes.
manufacturer may label his product as conforming to this Standard only if the product
fulfills the requirements of this specification.
5.2 Disclosure
A manufacturer shall disclose each specification listed, where applicable.
5.2.1 A manufacturer of a cryosystem shall provide a warning statement to inform
the user where contact with the cryosystem may cause user/patient harm. This
statement shall appear in the instrument’s instruction manual and, if possible, on
sections of the instrument that become 0°C or colder.
5.2.2 A cryosystem designed to spray a cryogen onto a target tissue must have a
disclosure statement warning the user to provide adequate protection to himself and
the patient due to excess or residual cryogen droplets or mist.
5.2.3 A disclosure 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.
5.2.4 A disclosure statement that states exactly what items of the cryosystem and its
accessories can be sterilized and the recommended sterilization procedures shall be
included with each cryosystem.
5.2.5 A disclosure statement shall be included with each pre-sterilized cryosystem.
a) Sterile;
b) The expiration date of sterilization;
c) Notes of caution concerning means of shipping, storage and use of the
instrument.
5.2.6 All ac powered cryosystems and accessories shall be prominently labeled
“Danger-Explosion Hazard. Do Not Use in Presence of Flammable Anesthetics”.
5.2.7 The following information shall be included in the disclosure statement for
tissue temperature monitors.
a) Type of cryometer (analog, digital, recorder),
b) Temperature range. minimum to maximum,
c) Type of thermocouple (for example, Type “T”),
d) Temperature and humidity limits for storage, shipping and operation, and
e) Power requirements.
c) Set up;
d) Use;
e) Dismantle;
f) Calibrations;
g) Intended Applications.
5.4.2.1 Specifications – Cryosystem and Cryogen.
a) Size;
b) Weight;
c) Type(s) of Cryogen(s) Used;
d) Minimum and Maximum Operation Pressure;
e) Power Requirements;
f) Temperature Control Description;
g) Cryosystem and Cryoprobe Performance Check
b) Defrost Features;
i) Temperature Sensor;
j) Serviceable Parts;
k) Manufacturer’s Recommended Cryogen Containers;
l) Thermal Insulation;
m) Specifications – Cryogen Container.
5.4.2.2 Recommended Withdrawal Devices.
a) Type(s) of Cryogen Employed;
b) Size;
c) Weight;
d) Capacity;
e) Static Hold Time. Container Only;
f) Static Hold Time. Container and Withdrawal Device;
g) Optimum and Maximum Operating Pressure;
h) Rating on Pressure Limiting Device;
i) Filling Directions;
j) Serviceable Parts.
5.4.3 Servicing Instructions.
a) Trouble-Shooting Chart;
b) Cryogen Flow Chart;
c) Electrical Schematics;
d) User Serviceable Parts List;
e) Preventive Maintenance Recommendations;
f) Warranty Information.
5.4.4 Electrical and Cryogen Safety Instructions.
a) User Related;
b) Patient Related.
5.4.5 Available Accessories.
6 Cryosystem Safety Requirements
6.1 General
These cryosystem safety requirements are intended to protect the user and patient
from harm during the use and storage of the cryosystem.
6.2 Mechanical Integrity
6.2.1 ...
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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