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Calibration Specification for Insufflators
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Basic data
| Standard ID | JJF 1892-2021 (JJF1892-2021) |
| Description (Translated English) | Calibration Specification for Insufflators |
| Sector / Industry | Metrology & Measurement Industry Standard |
| Classification of Chinese Standard | A53 |
| Word Count Estimation | 15,156 |
| Issuing agency(ies) | State Administration for Market Regulation |
JJF 1892-2021: Calibration Specification for Insufflators
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Calibration Specification for Insufflators
National Metrology Technical Specifications of the People's Republic of China
Insufflator calibration specification
Released on 2021-02-23
2021-08-23 implementation
Issued by the State Administration for Market Regulation
Insufflator calibration specification
forInsufflators
Focal point. National Medical Metrology Technical Committee
Main drafting unit. Guangzhou Institute of Metrology and Testing Technology
China Institute of Metrology
Participated in the drafting. Zhejiang Naxiong Medical Devices Co., Ltd.
This specification entrusts the National Medical Metrology Technical Committee to be responsible for the interpretation
The main drafters of this specification.
Hu Liangyong (Guangzhou Institute of Metrology and Testing Technology)
Zheng Chunxiong (Guangzhou Institute of Metrology and Testing Technology)
Li Fei (China Institute of Metrology)
Participating drafters.
Xiao Que (Zhejiang Naxiong Medical Devices Co., Ltd.)
table of Contents
Introduction (Ⅱ)
1 Scope (1)
2 Reference documents (1)
3 Terms and units of measurement (1)
4 Overview (1)
5 Measurement characteristics (2)
5.1 Air pressure setting error (2)
5.2 Error of barometric pressure display value (2)
5.3 Overpressure alarm air pressure difference (2)
5.4 Error of flow setting value (2)
5.5 Error of flow display value (2)
6 Calibration conditions (2)
6.1 Environmental conditions (2)
6.2 Measurement standards and other equipment (2)
7 Calibration items and calibration methods (3)
7.1 Visual inspection (3)
7.2 Functional inspection and preparation before calibration (3)
7.3 Air pressure setting error (3)
7.4 Error of barometric pressure display value (3)
7.5 Overpressure alarm air pressure difference (4)
7.6 Error of flow setting value (4)
7.7 Error of flow display value (4)
8 Calibration result expression (5)
8.1 Calibration record (5)
8.2 Processing of calibration results (5)
9 Re-calibration interval (5)
Appendix A Insufflator calibration record format (6)
Appendix B. Internal page format of calibration certificate (8)
Appendix C Evaluation Example of Measurement Uncertainty (9)
Introduction
The compilation of this specification is based on JJF 1071-2010 "Rules for the Compilation of National Metrology and Calibration Specifications", JJF 1001-2011
"General Metrology Terms and Definitions", JJF 1059.1-2012 "Evaluation and Expression of Measurement Uncertainty" as the basis and
in accordance with.
The formulation of this specification refers to YY0843-2011 "Medical Endoscope Endoscope Function Supply Device Pneumoperitoneum"
machine".
This specification is released for the first time.
Insufflator calibration specification
1 Scope
This specification applies to the calibration of the measurement characteristics of the insufflator.
2 Reference documents
The following documents are cited in this specification.
GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and basic performance
GB 9706.19 Medical electrical equipment Part 2.Special requirements for the safety of endoscopic equipment
YY0843-2011 medical endoscope endoscopic function supply device pneumoperitoneum machine
For dated reference documents, only the dated version applies to this specification; for all undated references
The latest version (including all amendments) is applicable to this specification.
3 Terms and units of measurement
3.1 Gaspressureofover-pressurealarm
Simulate the actual pressure value in the abdominal cavity when an overpressure alarm occurs in the insufflator, in Pa or mmHg
(mmHg).
3.2 Gaspressuredifferenceofoverpressurealarm
The difference between the overpressure alarm air pressure and the corresponding air pressure setting value, in Pa or millimeter mercury (mmHg).
3.3 Abdominal cavity simulator
A device that can simulate the characteristics of the patient's abdominal cavity.
3.4 (gascharging) scalefactor
Simulate the volume change per unit pressure in the abdominal cavity, in units of liters per pascal (L/Pa) or liters per millimeter of mercury
Column (L/mmHg).
4 overview
Pneumoperitoneum machine is a special device used to establish and maintain pneumoperitoneum in abdominal endoscopic surgery. It is mainly in laparoscopy
During the inspection and surgery, medical carbon dioxide gas is injected into the abdominal cavity, and the abdominal wall is separated from the abdominal internal organs with the gas to form
Surgical operation and visual field space. When it reaches a predetermined pressure, it can automatically stop the air intake and maintain a certain amount of gas to make the abdominal cavity
The inside has been in a predetermined pressure inflation state. When the air pressure in the abdominal cavity decreases during the operation, it can automatically inflate to maintain the hand
Necessary operation and observation space required for surgical operation. The establishment of pneumoperitoneum is the basis of laparoscopic surgery, and the maintenance of pneumoperitoneum depends on
The normal operation of the insufflator.
The insufflator is composed of an air intake tube, a main engine, a pneumoperitoneum tube, a filter, and a pneumoperitoneum needle. The main engine is mainly composed of decompression system
System, solenoid valve, air pressure sensor, flow sensor, safety valve, power supply and display device.
...
