YY/T 0450.3-2016 Accessory devices for sterile single-use intravascular catheters- Part 3：Inflation devices for balloon of balloon dilatation catheters English
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.
YY/T 0450.3-2016 The following standards are cited：
