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YY/T 0450 consists of the following 3 parts under the general title "Accessory devices for sterile single-use intravascular catheters":
——Part 1: Introducers;
——Part 2: Obturators for over-needle peripheral catheters;
——Part 3: Inflation devices for balloon of balloon dilatation catheters.
This is Part 3 of YY/T 0450.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0450.3-2007. In addition to editorial changes, the following technical main technical changes have been made with respect to YY 0450.3-2007:
——The structural type of the product is added to include the inflation devices for balloon of balloon dilatation catheters which has digital pressure instrument;
——The mark requirements of products are deleted;
——The requirements on and test methods for the digital pressure instrument are added;
——The “Compliance” is modified to “Pressure attenuation”, and its requirements and test methods are modified.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This part is under the jurisdiction of Jinan Center for Medical Equipment Quality Supervision and Testing, State Food and Drug Administration.
The previous edition replaced by this part is as follows:
——YY 0450.3-2007.
Accessory devices for sterile single-use intravascular catheters -
Part 3: Inflation devices for balloon of balloon dilatation catheters
1 Scope
This part of YY/T 0450 specifies the requirements of single-use manual inflation device for intravascular balloon dilatation catheters (hereinafter referred to as "inflation device"). This product is suitable for inflating the balloon of balloon dilatation catheter specified in YY 0285.4, so as to inflate it to expand the blood vessel or release the stent.
The release device of intravascular occlusion and the inflation device of balloon occlusion catheter have similar structures to the inflation device specified in this part, to which this standard does not apply.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 1962.2 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
GB 9706 Medical electrical equipment (all parts)
GB 15810 Sterile hypodermic syringes for single use
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 19633.1-2015 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
YY 0505 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standards: Electromagnetic compatibility - Requirements and tests
YY/T 0615.1 Requirements for medical devices to be designated “STERILE” - Part 1: Requirements for terminally sterilized medical devices
3 Structural type
The inflation devices are mainly composed of a push-injecting system, a pressure instrument and a connecting pipeline. The pressure instrument is classified into pointer pressure instrument and digital pressure instrument.
4 Pointer pressure instrument
4.1 Measurement units
The pressure instrument shall be expressed in two sets of measurement units, i.e., atm1)/MPa or atm/psi1) at the same time. atm scale is marked on the outer ring, and MPa or psi unit is marked on the inner ring.
4.2 Zero
The zero scale line of the pressure instrument shall be located between the two kinds of scales, with the positive pressure part from zero to the right (clockwise) and the vacuum part from zero to the left (counterclockwise).
4.3 Division
The minimum division value of MPa scale shall be 0.1 MPa, with the number interval not exceeding 0.5mpa; that of atm scale shall be 1 atm, with the number interval not exceeding 5 atm, and that of psi scale shall not exceed 50 psi, with the number interval not exceeding 100 psi.
4.4 Negative pressure indication
It is allowed that the negative pressure area of the pressure instrument has no division, but a range indicating negative pressure (e.g., sector area) shall be given and marked with the words "VAC" or "vacuum".
Note: In clinical use, in order to take out the dilatated catheter easily, it is required to apply negative pressure to the balloon.
4.5 Intrinsic error
In case of testing according to A.5, the intrinsic error of pressure instrument shall be expressed as fiducial error (counted as a percentage of measurement range), and the intrinsic error limit in more than 90% of the measurement range shall be ±4.0%, and that in other measurement ranges shall be ±3.0%.
Note: The precision grade of the instrument shall be expressed by the intrinsic error limit of "the rest part except the range more than 90% of the measurement range".
4.6 Hysteresis error
In case of testing according to A.6, the hysteresis error indicated by the pressure instrument shall not be greater than the absolute value of intrinsic error limit.
4.7 Stationarity of pointer deflection
In case of testing according to A.7, the instrument pointer shall be free from the phenomena of jumping and stagnation during measurement.
4.8 Friction error
In case of testing according to A.8, when tapping the instrument housing with fingers at any position within the measurement range (so that the pointer can swing freely), the change amount of the indication value of the pointer shall not be greater than 1/2 of the absolute value of the intrinsic error limit.
5 Digital pressure instrument
5.1 Measurement unit
The pressure instrument shall be expressed in at least two sets of measurement units, namely atm/MPa or atm/psi.
5.2 Zero drift
In case of testing according to B.5, the zero drift of the pressure instrument shall not be greater than 1/2 of the absolute value of the intrinsic error limit within 1 h.
5.3 Indication value resolution
For the indication values, in the case of the unit in MPa, the pressure shall be able to be increased or decreased by no more than 0.1 MPa; in the case of the unit in atm, the pressure shall be able to be increased or decreased by no more than 1 atm; in the case of the unit in psi, the pressure shall be able to be increased or decreased by no more than 50 psi.
5.4 Negative pressure indication
The pressure instrument shall be capable of indicating negative pressure and marked with "-"or other equivalent words to clearly distinguish from positive pressure.
Note: In clinical use, in order to take out the dilatated catheter easily, it is required to apply negative pressure to the balloon.
5.5 Intrinsic error
In case of testing according to B.6, the intrinsic error of pressure instrument shall be expressed as fiducial error (counted as a percentage of measurement range), and the intrinsic error limit in more than 90% of the measurement range shall be ±4.0%, and that in other measurement ranges shall be ±3.0%.
Note: The precision grade of the instrument shall be expressed by the intrinsic error limit of "the rest part except the range more than 90% of the measurement range".
5.6 Repeatability
In case of testing according to B.7, the repeatability of the pressure instrument shall not be greater than the absolute value of intrinsic error limit.
5.7 Hysteresis error
In case of testing according to B.8, the hysteresis error indicated by the pressure instrument shall not be greater than the absolute value of intrinsic error limit.
5.8 Stability
In case of testing according to B.9, the stability of the pressure instrument shall not be greater than the absolute value of intrinsic error limit.
5.9 Fluctuation of indication values
In case of testing according to B.10, the indication value fluctuation of the pressure instrument shall not be greater than 1/3 of the absolute value of intrinsic error limit.
5.10 Safety requirements
5.10.1 The electrical safety of the digital pressure instrument shall meet those specified in GB 9706.
5.10.2 The electromagnetic compatibility of the digital pressure instrument shall meet those specified in YY 0505.
Foreword i
1 Scope
2 Normative references
3 Structural type
4 Pointer pressure instrument
4.1 Measurement units
4.2 Zero
4.3 Division
4.4 Negative pressure indication
4.5 Intrinsic error
4.6 Hysteresis error
4.7 Stationarity of pointer deflection
4.8 Friction error
5 Digital pressure instrument
5.1 Measurement unit
5.2 Zero drift
5.3 Indication value resolution
5.4 Negative pressure indication
5.5 Intrinsic error
5.6 Repeatability
5.7 Hysteresis error
5.8 Stability
5.9 Fluctuation of indication values
5.10 Safety requirements
6 Service performance of inflation devices
6.1 Tightness under positive pressure
6.2 Pressure release
6.3 Negative pressure retention
6.4 Pressure attenuation
6.5 Working reliability of release device
6.6 Rotation direction
6.7 Joint
6.8 Bubble observation and exhaustion
6.9 Extension pipe size
6.10 Capacity scale
6.11 Capacity tolerance
7 Chemical performance
8 Biological performances
8.1 Sterility
8.2 Biocompatibility
9 Marking
10 Packaging
Annex A (Normative) Method for testing performances of pointer pressure instrument
A.1 Test conditions
A.2 Test apparatus
A.3 Inspection points
A.4 Test method
A.5 Intrinsic error test
A.6 Hysteresis error test
A.7 Test for stationarity of pointer deflection
A.8 Fraction error test
Annex B (Normative) Method for testing performances of digital pressure instrument
B.1 Test conditions
B.2 Test apparatus
B.3 Inspection points
B.4 Debugging method
B.5 Zero drift test
B.6 Intrinsic error test
B.7 Repeatability test
B.8 Hysteresis error test
B.9 Stability test
B.10 Test for fluctuation of indication values
Annex C (Normative) Test of performances of inflation devices
C.1 Test conditions
C.2 Pressure release test
C.3 Negative pressure retention test
C.4 Pressure attenuation test
C.5 Capacity tolerance
Annex D (Informative) Example of comparison chart of measurement units provided by manufacturer to user
Bibliography
