WS/T 656-2019 English PDFUS$429.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. WS/T 656-2019: Safety management for anaesthetic machine Status: Valid
Basic dataStandard ID: WS/T 656-2019 (WS/T656-2019)Description (Translated English): Safety management for anaesthetic machine Sector / Industry: Health Industry Standard (Recommended) Classification of Chinese Standard: C05 Word Count Estimation: 17,162 Date of Issue: 2019-10-18 Date of Implementation: 2020-05-01 Regulation (derived from): National Health Communication (2019) No. 11 Issuing agency(ies): National Health Commission WS/T 656-2019: Safety management for anaesthetic machine---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.Safety management for anaesthetic machine ICS 11.020 C 05 WS People's Republic of China Health Industry Standard Anesthesia machine safety management 2019-10-18 released 2020-05-01 implementation Published by the National Health Committee of the People's Republic of China ContentsForeword ... II 1 Scope ... 1 2 Normative references ... 1 3 Terms and definitions ... 1 4 Basic Management Requirements ... 1 4.1 Management organization ... 2 4.2 Management responsibilities ... 2 4.3 Management System ... 2 4.4 File Management ... 3 5 Personnel requirements ... 3 6 Environmental requirements ... 3 7 Safety controls ... 3 7.1 Acceptance of newly purchased anesthesia machine ... 4 7.2 Safety confirmation before use ... 4 7.3 Monitoring in use ... 5 7.4 Performance testing ... 5 7.5 Maintenance ... 6 7.6 Maintenance ... 6 8 Cleaning and disinfection ... 7 Appendix A (Informative) Safety Confirmation Record of Anesthesia Machine Before Use ... 8 Appendix B (informative) Simulated ventilation test of anesthesia machine ... 9 Appendix C (Informative) Determination of Concentration of Gas Conveyed by Evaporator ... 10 Appendix D (Normative Appendix) Anesthesia Ventilator Inspection ... 11 Appendix E (informative) Safety management test records of anesthesia machine ... 12 References ... 14ForewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard was drafted. Chinese People's Liberation Army General Hospital, Chinese Medical Equipment Association, Eastern Theater General Hospital, Chinese People's Liberation Army The General Instrument and Equipment Inspection and Supervision Station of the Joint Logistics Support Army, Nanjing Hospital (Nanjing First Hospital) affiliated to Nanjing Medical University, Nanjing Medical University Nanjing Drum Tower Hospital Affiliated to the College. The main drafters of this standard. Yan Yong, Zhou Juan, Cao Desen, Mi Weidong, Wu Hao, Liu Xiaozheng, Liu Tiebing, Li Yongxue, Zhu Yan, Zhang Yan Jun, Zu Hefei, Si Yana, Wang Yanyan, Li Xinsheng. Anesthesia machine safety management1 ScopeThis standard specifies the acceptance, personnel, use environment, and safety of anesthesia machines used by medical institutions before and during clinical use. Performance and maintenance related management and technical requirements. This standard applies to the safety management of anesthesia machines used clinically by medical institutions. This standard does not apply to anesthesia machines and portable anesthesia machines that use flammable anesthetics such as cyclopropane and ether.2 Normative referencesThe following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest version (including all amendments) applies to this document. GB 9706.29 Medical electrical equipment. Part 2. Particular requirements for the safety and basic performance of anesthesia systems GB 15982 Sanitary Standards for Hospital Disinfection JJF 1234 Ventilator Calibration Specification WS/T 367 Medical Institution Disinfection Technical Specification WS 392 ventilator clinical application3 terms and definitionsGB 9706.29, JJF 1234 and the following terms and definitions apply to this standard. 3.1 Anesthesia machine Equipment that distributes and delivers various medical and anaesthetic gases and vapors to the respiratory system. 3.2 Anaesthetic ventilator A ventilator designed for use during anesthesia. 3.3 Anaesthetic vaporizer A device capable of providing volatile pharmaceutical vapors in a controlled concentration manner. 3.4 Common gas outlet Port for anesthetic gas and vapor output from anesthesia machine. 3.5 Manager of clinical anaesthetic machines The personnel who manage the anesthesia machine equipped in the anesthesia machine use department of the medical institution.4 Management requirements4.1 Management organization Anesthesia machine security is composed of the head of the medical institution, the medical business management department, the medical device management department and the anesthesia machine use department. Full management organization. 4.2 Management responsibilities 4.2.1 The leaders of medical institutions shall perform the following duties. a) Have leadership responsibility for the safety control of the anesthesia machine; b) Responsible for coordinating the deployment of medical device managers, medical engineering technicians and related testing equipment needed for the safety management of anesthesia machines. 4.2.2 The medical service management department shall perform the following duties. a) Coordinate and manage key links and activities in the safety control of anesthesia machines; b) organize the development of anesthesia machine safety control plan and management system and supervise implementation; c) Develop an emergency deployment system for anesthesia machines. 4.2.3 The medical device management department shall perform the following duties. a) Formulate safe operating procedures for anesthesia machines; b) organize the acceptance testing, periodic testing, maintenance, repair and post-repair testing of the anesthesia machine; c) Train the department and operator of anesthesia machine on the safe operation procedures of anesthesia machine; d) Collect the safety information of the anesthesia machine, conduct the annual safety control evaluation, submit the evaluation report to the safety management organization of the anesthesia machine and propose improvements Comments. 4.2.4 The user department shall perform the following duties. a) Organize personnel in this department to study and implement the safety control plan and management system of anesthesia machine; b) organize the operators to receive training and assessment of the operating procedures of the anesthesia machine; c) Equipped with clinical anesthesia machine management personnel (can work part-time). 4.3 Management System 4.3.1 Anesthesia machine safety management system should include. acceptance system, use registration system, emergency deployment system, maintenance system, cycle Inspection system, archive management system, etc. 4.3.2 The acceptance system should include the following. a) Check the qualifications of production enterprises and distributors; b) check the factory test report or certificate and its validity period; c) check the instruction manual and maintenance manual; d) check incidental services; e) Carry out the acceptance test of the anesthesia machine, record it, and keep it on file. 4.3.3 The use registration system should include the following. a) Each anesthesia machine should be provided with a use register; b) The use register should contain the equipment's name, model, serial number, storage location, date of use, etc .; c) When using anesthesia machines, the use date and start and end time, the user's name, the pre-use status and post-use status of the safety confirmation item should be registered; d) Safety confirmation records before use. For sample records, see Table A.1 in Appendix A. 4.3.4 The emergency deployment system should include the following. a) the person responsible for emergency deployment; b) emergency deployment procedures; c) Routine maintenance of emergency anesthesia machine. 4.3.5 The maintenance system shall include the following. a) the person responsible for maintenance; b) maintenance cycle and content; c) maintenance records. 4.3.6 The periodic inspection system should include the following. a) the person in charge of the periodic inspection; b) the time limit of the detection cycle; c) Records of inspections; d) Detection status identification. 4.4 File management 4.4.1 Archives and materials shall be kept by a special person designated by the medical device management department or unifiedly kept by the medical institution's file management department. 4.4.2 The administrative file shall include the following. a) record of use process; b) maintenance process records; c) cleaning and disinfection records; d) emergency deployment records; e) other management records. 4.4.3 The technical files shall include the following. a) Manual of anesthesia machine; b) Anesthesia machine maintenance manual; c) factory test report or certificate of conformity; d) Various inspection records. 4.4.4 Archives shall be kept for 5 years after the equipment is terminated.5 Staff requirements5.1 Clinical anesthesia machine managers should receive training in basic principles and performance knowledge of anesthesia machines, master the requirements of anesthesia machine management systems, and Evaluation by the medical device management department. 5.2 The medical engineering personnel responsible for the maintenance and safety inspection of the anesthesia machine should be familiar with the working principle, operation methods and detection specifications of the anesthesia machine. 5.3 The personnel responsible for the maintenance and safety inspection of the anesthesia machine should have a corresponding college degree or above in engineering or undergo relevant technical training. 5.4 The user of the anesthesia machine should be a professional physician in anaesthesia, who has been trained in the operating procedures of the anesthesia machine and passed the assessment.6 Environmental requirements6.1 Provide uninterrupted power supply and air supply. 6.2 The place is equipped with a ground wire. 6.3 The entrance of each medical gas supply shall meet the requirements of GB 9706.29. 6.4 The inlet joints of each gas pipeline are dedicated and cannot be interchanged. 6.5 For malfunctioning anesthesia machines, the “temporary malfunction” sign should be affixed, and they should be evacuated in time. 6.6 Have a backup power source that has been tested to work well.7 Security controls7.1 Acceptance of newly purchased anesthesia machine 7.1.1 Should be carried out jointly by the manufacturer or agent of the anesthesia machine, the department using the anesthesia machine, and the medical device management department. 7.1.2 Anesthesia machines that fail to pass the inspection shall be returned, exchanged and returned to the factory for maintenance. 7.2 Safety confirmation before use 7.2.1 The safety of the anesthesia machine should be confirmed by the personnel of the user department before each use. 7.2.2 Safety confirmation items before use include emergency breathing equipment inspection, high pressure system inspection, low pressure system test, flow meter, anesthesia waste Air purification system adjustment and inspection, respiratory system inspection, simulated ventilation test of anesthesia machine and standby status after its inspection. 7.2.3 Emergency breathing equipment should be maintained in good performance. 7.2.4 The high voltage system shall meet the following requirements. a) The gas supply system is connected correctly to the reinforced hose of the anesthesia machine; b) The pressure of the oxygen cylinder should be ≥7.0 MPa; c) The central oxygen supply system shall ensure that the pressure at the terminal of the anesthesia machine is not less than 0.4 MPa. 7.2.5 The low-voltage system shall meet the following requirements. a) In the initial state, the flow control valve and the evaporator are closed, the evaporator has sufficient medicine, and the medicine cap is tightly closed. b) Close the main switch and the flow regulating valve, connect the common gas outlet to the negative pressure suction ball, and squeeze the suction ball until it fully collapses. Suck ball The collapse holding time should be ≥10 s. Open the evaporator one by one and repeat the inspection. Low-pressure systems should be leak-free. 7.2.6 The flow meter shall meet the following requirements. a) When the gas flow is adjusted within the full range, the flowmeter float moves smoothly and the flow tube is not damaged; b) Adjust the N2O flow rate to be more than 5 times of O2. The flowmeter adjustment should be limited or an alarm should occur. 7.2.7 Anesthetic exhaust gas purification system shall meet the following requirements. a) The anesthesia purification system should be correctly connected with the APL valve (adjustable pressure-limiting valve) and the ventilation release valve connection; b) When the APL valve is fully opened and the Y-tube is blocked, the anesthesia circuit airway pressure should Zero c) In the case of rapid inflation of the rapid oxygenation airbag, the airway pressure of the anesthesia circuit should be ≤10 cm H2O. 7.2.8 Respiratory system inspection shall include calibration of the oxygen concentration monitor readings, inspection of the initial state of the respiratory system, and inspection of the breathing circuit leakage. 7.2.8.1 The oxygen concentration monitor reading shall meet the following requirements. a) Low oxygen concentration alarm function should be normal; b) During rapid oxygenation, the oxygen concentration monitor should read more than 90%. 7.2.8.2 The initial state of the respiratory system shall meet the following requirements. a) In manual mode, the breathing circuit should be complete, non-destructive and non-blocking; b) CO2 absorbent should be sufficient; c) Respiratory circuit accessories such as humidifiers, positive end-expiratory pressure (PEEP) valves have been installed Installed. 7.2.8.3 The breathing circuit is free of leaks and shall meet the following requirements. a) When all flows are set to zero (or minimum) and the APL valve is closed and the patient end of the anesthesia bellows Y-joint is blocked, When oxygen makes the airway pressure reach about 30 cm H2O and the rapid oxygen switch is turned off, the airway pressure should remain stable for ≥10 s; b) Open the APL valve and the airway pressure should drop to zero. 7.2.9 After the inspection according to 7.2.3 to 7.2.8, a simulated ventilation test of the anesthesia machine shall be performed. See Appendix B for test methods. 7.2.10 Anesthesia machine should be in the following standby state after safety inspection. a) All flowmeter displays should be zero; b) the suction device is ready; c) the respiratory system is functioning well and is readily available; d) the ventilation switch is placed in manual mode; e) the anesthesia vaporizer is closed; f) APL valve is open. 7.2.11 The anesthesia machine should be checked before the first operation every day in accordance with the requirements of 7.2.2 ~ 7.2.10. When the same anesthesia machine is operated in series, It is only necessary to perform a breathing circuit leak check, an anesthesia machine simulated ventilation test, and confirm the standby state after the inspection of the anesthesia machine. 7.2.12 The anesthesia machine found to be abnormal upon safety confirmation shall be discontinued and the medical device management department shall be notified for maintenance or testing. 7.2.13 The contents of the safety confirmation record before using the anesthesia machine are shown in Table A.1 of Appendix A. 7.3 In-use monitoring During use, the user of the anesthesia machine should closely observe the physiological parameters of the patient. When problems with anesthesia machine equipment are suspected, Handle in time and even replace the equipment. 7.4 Performance testing 7.4.1 The technical personnel of the medical device management department are responsible for the detection of the anesthesia machine. 7.4.2 This medical institution does not have the conditions for anesthesia machine testing, and should entrust other technical service institutions with the conditions for anesthesia machine testing. 7.4.3 The detection cycle of the anesthesia machine should be ≤1 year. 7.4.4 Anesthesia machine testing should use special equipment (including lung simulator, ventilator detector, anesthesia gas monitor, etc.), and should comply with the following Column requirements. a) Simulated lung and ventilator detectors shall meet the requirements of JJF 1234; b) The anesthesia gas analyzer should meet the accurate level of gas concentration measurement given in Table 1. Table 1 Accuracy of gas concentration measurement Gas concentration (% by volume) Gas measurement accuracy Halogens ± (0.2% by volume and 15% by gas concentration) Carbon dioxide ± (0.43% by volume, 8% by gas concentration) Nitrous oxide (laughing gas) ± (2.0% 8% by volume gas concentration) Oxygen ± (2.5% by volume, 2.5% by gas concentration) 7.4.5 The testing environment shall meet the following requirements. a) The temperature is 23 ℃ ± 2 ℃; b) Relative humidity is 60% ± 15%; c) The atmospheric pressure is from 86 kPa to 106 kPa. 7.4.6 Performance testing items shall include safety alarm function inspection, APL valve inspection, oxygen laugh linkage inspection, gas mixer inspection, Evaporator inspection, common gas outlet inspection, rapid oxygen supply inspection, anesthesia ventilator inspection. 7.4.6.1 Prepare the ambient temperature and humidity and preheat the equipment according to the instruction manual of the anesthesia machine and the requirements of the detection equipment of the anesthesia machine. 7.4.6.2 Visually observe whether the anesthesia machine has mechanical damage that affects its normal working performance, and whether the control knob on the panel is in the correct position, Good contact and clear steps. 7.4.6.3 The safety alarm function shall meet the following requirements. a) After powering on, disconnect the power supply, and the power supply failure alarm function should be activated; b) Connect the anesthesia machine to the air source so that the oxygen supply pressure is lower than the manufacturer's requirements, and the oxygen supply failure alarm should be activated; c) Connect the ventilator tester, simulated lung and anesthesia machine to reduce the exhaled tidal volume or minute ventilation to below the operator adjustable threshold When the value is low, the low exhaled volume alarm signal should be activated within 90 s; d) Disconnect each removable anesthesia ventilation system and anesthesia ventilator in turn, and the ventilation system integrity alarm should be activated; e) Set the airway pressure high alarm threshold, adjust the airway pressure so that the peak value of the airway pressure reaches the alarm high limit allowable value for 15 s The continuous high pressure alarm should be activated. 7.4.6.4 APL valves shall meet the following requirements. a) In the state of machine control, the pressure range of the regulating valve should not affect the mechanical ventilation. b) The anesthesia machine is set to manual, and the manual sac is inflated by rapid oxygen supply. Set the pressure value of the APL valve to 30 cm H2O, 50 cm H2O, 70 cm H2O. Pinch the bladder firmly. When the pressure exceeds a predetermined value, the APL valve should automatically release the pressure. 7.4.6.5 The oxygen laugh linkage device shall meet the following requirements. a) Turn the laughing gas knob, and the oxygen knob should be turned on; b) Turn off the oxygen knob, and the laughter knob should be turned off. 7.4.6.6 Set the oxygen concentration value to be calibrated, and record the oxygen concentration value detected by the ventilator tester. The oxygen concentration error of the gas mixer should not exceed ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of WS/T 656-2019_English be delivered?Answer: Upon your order, we will start to translate WS/T 656-2019_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. 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