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Safety management for infusion pump and syringe pump
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Basic data
| Standard ID | WS/T 657-2019 (WS/T657-2019) |
| Description (Translated English) | Safety management for infusion pump and syringe pump |
| Sector / Industry | Health Industry Standard (Recommended) |
| Classification of Chinese Standard | C05 |
| Word Count Estimation | 12,179 |
| Date of Issue | 2019-10-18 |
| Date of Implementation | 2020-05-01 |
| Regulation (derived from) | State-Health-Communication (2019) No. 13 |
| Issuing agency(ies) | National Health Commission |
WS/T 657-2019: Safety management for infusion pump and syringe pump
---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 infusion pump and syringe pump
ICS 11.020
C 05
WS
People's Republic of China Health Industry Standard
Safety management of medical infusion pumps and medical syringe pumps
Published on October 18,.2019
2020-05-01 implementation
Published by the National Health Committee of the People's Republic of China
Contents
Foreword ... II
1 Scope ... 1
2 Normative references ... 1
3 Terms and definitions ... 1
4 Basic requirements ... 1
4.1 Management Organization ... 1
4.2 Management responsibilities ... 1
4.3 Management System ... 2
5 Technical requirements for safety management ... 3
5.1 Acceptance of newly purchased infusion equipment ... 3
5.2 Visual inspection ... 3
5.3 Management of the use of infusion equipment ... 3
5.4 Maintenance management of infusion equipment ... 3
5.5 Deactivation of the infusion device ... 4
6 Technical requirements for safety inspection ... 4
6.1 Test conditions ... 4
6.2 Electrical safety inspection ... 4
6.3 Performance testing ... 4
Appendix A (informative) Original records of medical infusion pump testing ... 5
Appendix B (Informative) Original Records of Medical Syringe Pump Testing ... 7
References ... 9
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard was drafted. Xuanwu Hospital of Capital Medical University, Shanghai Renji Hospital, Beijing Shunyi District Hospital, China Medical Equipment Association,
Institute of Hospital Management, National Health and Health Commission.
The main drafters of this standard. Yan Hanmin, Bai Mei, Zhang Jian, Zhao Jian, Zhao Zilin, Hou Yiwei, Guo Yu, Liu Yuan, and Wang Xiaolong.
Safety management of medical infusion pumps and medical syringe pumps
1 Scope
This standard specifies the use of medical infusion pumps and syringe pumps (hereinafter referred to as infusion equipment) in medical institutions before clinical use and use.
During the use of safety and performance testing management requirements.
This standard applies to the safety management of medical infusion pumps and syringe pumps used clinically by various medical institutions.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB 9706.1 Medical electrical equipment. Part 1. General requirements for safety
GB 9706.27 Medical electrical equipment Part 2-24. Particular requirements for the safety of infusion pumps and controllers
JJF 1259 Calibration Specifications for Medical Syringe Pumps and Infusion Pumps
YY 0505 Medical electrical equipment. Part 1-2. General requirements for safety. Collateral standard. EMC requirements and tests
3 terms and definitions
The terms and definitions defined in GB 9706.1, GB 9706.27, YY 0505 and JJF 1259, as well as the following terms, apply to this document.
3.1
Infusion pump
Devices that are intended to control the flow of fluid into a patient by the positive pressure generated by a pump.
3.2
Infusion pump
Through one or more single-acting syringes or similar containers, the operator sets the flow rate per unit time to control the injection into the patient
Device for fluid flow in the body.
3.3
Supporting materials
Pump infusion lines and syringes for use with infusion equipment.
4 Basic requirements
4.1 Management organization
Headed by the head of the medical institution, medical business management department, medical device management department, medical device use department and logistics support department
Together form an infusion equipment safety management organization.
4.2 Management responsibilities
4.2.1 The leaders of medical institutions shall perform the following duties.
a) Responsible for the safety management of infusion equipment;
b) Resource allocation to ensure the safe management of infusion equipment.
4.2.2 The medical service management department shall perform the following duties.
a) Organize the development of safety control plans and management systems for infusion equipment and supervise their implementation;
b) Coordinate the safety management of infusion equipment of various departments.
4.2.3 The medical device management department (including medical engineering department, equipment department, equipment department, equipment department, etc.) shall perform the following duties.
a) Fully responsible for the technical work of safety management of infusion equipment;
b) Formulate technical operation specifications for safety control of infusion equipment;
c) Training and assessment of the users and operating personnel in 4.2.3 b);
d) Responsible for maintenance, repair and performance testing of infusion equipment;
e) Formulate emergency backup plan and emergency deployment system for infusion equipment;
f) Collect safety management information of infusion equipment, conduct annual safety control evaluation, and submit evaluation reports to the safety management organization of medical institutions
And put forward suggestions for improvement.
4.2.4 The user department shall perform the following duties.
a) Organize personnel in this department to study and implement safety management system for infusion equipment;
b) organize the operators to receive training in technical operation specifications, and operate only after passing the assessment;
c) responsible for routine maintenance of infusion equipment;
d) Report any problems with the infusion equipment to the medical device management department and record them in a timely manner;
e) There should be full-time or part-time safety management personnel who are responsible for the daily management of the infusion equipment of the department.
4.2.5 The logistics support department shall provide power supply that meets the requirements of the infusion equipment.
4.3 Management System
4.3.1 A safety management system for infusion equipment should be established and publicized for implementation.
4.3.2 The safety management system of infusion equipment shall include inspection and inspection system, maintenance system, failure report system, emergency plan (emergency
Deployment) system and training evaluation system.
4.3.3 The inspection system includes the following.
a) Duties of inspectors;
b) inspection cycle;
c) content requirements for inspections;
d) Inspection inspection requirements;
e) Disposition of violations.
4.3.4 The maintenance system shall include the following.
a) the person in charge of maintenance;
b) maintenance intervals and requirements;
c) procedures and requirements for hidden dangers and failures;
d) Management of maintenance files.
4.3.5 The fault reporting system should include the following.
a) fault reporting procedures;
b) troubleshooting procedures;
c) Failure report, failure reason and processing record.
4.3.6 The emergency plan system should include the following.
a) Duties of the person responsible for the emergency plan;
b) emergency procedures;
c) Routine maintenance of emergency infusion equipment.
4.3.7 The training assessment system should include the following.
a) content, methods, time, goals, plans of training;
b) assessment of training, including assessment items, cycles, evaluation criteria and performance records;
c) Pre-job training and assessment for new employees.
5 Technical requirements for safety management
5.1 Acceptance of newly purchased infusion equipment
5.1.1 The acceptance of newly purchased infusion equipment shall be determined by the medical device management department together with the infusion equipment user department and supplier according to the order contract,
Configuration list and other related documents for acceptance;
5.1.2 The materials that the supplier should provide include product inspection reports and certificates of conformity, instruction manuals, and maintenance manuals;
5.1.3 The newly purchased infusion equipment shall be subject to acceptance testing in accordance with the equipment manual;
5.1.4 The acceptance results shall be recorded and archived. Acceptance records are kept until 5 years after the infusion device is terminated.
5.2 Visual inspection
5.2.1 The appearance of the equipment should be clean and tidy, the surface of the pump body should be clean, there should be no dirt on the injection pump tank, no dirt on the infusion pump door, and no dirt on the sensor part
mark.
5.2.2 The indications shall be normal when power is supplied from the external power supply and internal power supply (powered battery) of the device.
5.2.3 All parts of the pump (box, power cord, pull bolt, rack bar, clamp, infusion pump door, etc.) are in good condition.
5.2.4 All switches and buttons should be effective and sensitive.
5.2.5 Under daily illumination or light, the screen display content should be clear and legible.
5.2.6 The warning signs are clear. The alarm function works normally. In addition to the indicator or screen display, it should be accompanied by an audible alarm.
5.3 Management of infusion equipment use
5.3.1 The place of use of the infusion equipment shall meet the requirements of the equipment manual.
5.3.2 The infusion equipment user should be a practicing physician or a nurse. The user should be trained in the use of the equipment.
Get on the job and strictly follow the product instruction manual, technical operation specifications and procedures.
5.3.3 Before using the infusion equipment, the operator should confirm and record the equipment appearance, clock system and working status.
Before use.
5.3.4 Preventive maintenance of infusion equipment should be carried out regularly, maintenance intervals and maintenance requirements of infusion equipment should be formulated, and maintenance of infusion equipment should be established
Maintenance archives; regularly perform performance testing of infusion equipment in accordance with the requirements of Chapter 6, once a year, the original record form for testing can be referred to
Record A and Appendix B.
5.3.5 Infusion equipment should use special matching consumables.
5.3.6 The electromagnetic compatibility of the infusion equipment should meet the requirements of YY 0505.
5.4 Maintenance management of infusion equipment
5.4.1 The medical device management department shall arrange professional and technical personnel to be responsible for the maintenance of the infusion equipment.
5.4.2 The infusion equipment use department should stop using the equipment in time if it finds that the equipment is abnormal, and notify the medical device management department to arrange maintenance
repair.
5.4.3 After maintenance, the performance of the infusion equipment should be tested according to the requirements of Chapter 6, and it can be put into clinical use after passing the test.
5.5 Deactivation of infusion equipment
Infusion equipment should be decommissioned if.
a) If the test fails, it cannot meet the requirements for use;
b) serious damage cannot be repaired;
c) there is electrical danger or mechanical danger, which may endanger human safety and health.
6 Technical requirements for safety testing
6.1 Test conditions
6.1.1 The test shall be performed by the technical staff of the medical device management department of the medical institution.
6.1.2 Medical institutions without testing conditions shall be entrusted to medical institutions or social technical service institutions with testing capabilities.
6.1.3 The test conditions and methods shall comply with the provisions of JJF 1259.
6.2 Electrical safety inspection
6.2.1 The grounding resistance shall meet the requirements of GB 9706.1.
6.2.2 Case leakage current, patient leakage current, and patient auxiliary leakage current shall meet the requirements of GB 9706.1 and GB 9706.27.
6.3 Performance testing
6.3.1 basic flow error
6.3.1.1 Set the detection flow on the detector and the infusion device, respectively. For infusion pumps, the detection flow can be set to 25 mL/h and
100ml/h; for syringe pumps, the detection flow can be set to 5 mL/h and 25 mL/h.
6.3.1.2 When testing, record after the flow is stable; at the same time, start the infusion equipment and tester to start testing. When the test is complete,
Record average traffic. Each flow point is measured at least 3 times.
6.3.1.3 Calculate the basic error of the flow according to the requirements of JJF 1259.
6.3.1.4 For the acceptance test, the basic error of the flow rate of the infusion equipment should be evaluated with reference to the manufacturer's technical parameters; for in-use detection,
The basic error of the infusion equipment flow should meet the requirements of JJF 1259.
6.3.2 Blocking alarm pressure threshold error
6.3.2.1 Set the flow of the infusion device. If the pressure thresholds for the blocked alarm pressure of the tested equipment can be selected, set them to the minimum and maximum respectively.
Value to complete the blocking alarm test.
6.3.2.2 Start the infusion equipment tester, record the block alarm time and the block alarm pressure threshold, and check whether the infusion line appears
Cracked or dripping.
6.3.2.3 For the acceptance test, the maximum allowable error between the set value of the blocking alarm pressure and the threshold value of the blocking alarm pressure shall refer to the manufacturer's technology
The operating parameters are evaluated; the maximum allowable error between the set alarm blocking pressure setting value and the blocking alarm pressure threshold during use should meet
JJF 1259 requirements.
6.3.3 Alarm function
The alarm check shall comply with the requirements of JJF 1259 and the equipment manual.
Appendix A
(Informative appendix)
Raw records of medical infusion pump tests
Table A.1 Raw Records of Medical Infusion Pump Tests (Format)
Device code device name
Manufacturer of inspection department
Serial number specifications
Purpose of detection
Test conditions
Testing equipment name
Calibration temperature ℃
Test humidity% test date
Appearance state
Equipment appearance
Power indication
All parts of the pump
Switches and buttons
Display content
Warning sign
Electrical Safety
Ground resistance
Case leakage current
mA
Patient leakage current
mA
Basic flow error
Set flow value
mL/h
Measured value
mL/h
Relative error
First measurement value 25
Second measured value 25
3rd measured value 25
Average 25
First measurement value 100
Second measurement value 100
3rd measured value 100
Average 100
Obstruction pressure detection
Set blocking alarm pressure threshold
kPa
Occurrence of blocking alarm
min
Measured blocking alarm pressure threshold
kPa
error
kPa
Minimum value
Max
Inspection of pipelines □ Complete □ Cracked □ Dew drops
Table A.1 (continued)
Alarm function check
Door open alarm □ Meet the requirements □ Not meet the requirements Bubble alarm □ Meet the requirements □ Not meet the requirements
Alarm after completion of infusion
in conclusion.
Reviewer. Review date. year, month, day
Appendix B
(Informative appendix)
Medical syringe pump test raw record
Table B.1 Raw Records of Medical Syringe Pump Testing (Format)
Device code device name
Manufacturer of inspection department
Serial number specifications
Purpose of detection
Test conditions
Testing equipment name
Calibration temperature ℃
Test humidity% test date
Appearance state
Equipment appearance
Power indication
All parts of the pump
Switches and buttons
Display content
Warning sign
Electrical Safety
Ground resistance
Case leakage current
mA
Patient leakage current
mA
Basic flow error
Set flow value
mL/h
Measured value
L/h
Relative error
First measurement value 5
2nd measured value 5
3rd measured value 5
Average 5
First measurement value 25
Second measured value 25
3rd measured value 25
Average 25
Obstruction pressure detection
Set blocking alarm pressure threshold
kPa
Occurrence of blocking alarm
min
Measured blocking alarm pressure threshold
kPa
error
kPa
Minimum value
Max
Inspection of pipelines □ Complete □ Cracked □ Dew drops
Table B.1 (continued)
Alarm function check
Door open alarm □ Meet the requirements □ Not meet the requirements Bubble alarm □ Meet the requirements □ Not meet the requirements
Alarm after completion of infusion
in conclusion.
Reviewer. Review date. year, month, day
references
[1] Safety Management Regulations for Clinical Use of Medical Devices (Trial) Wei Yi Guan Fa [2010] No. 4
[2] Health Regulations on Medical Equipment Management of Medical Institutions [2011] No. 24
[3] Detailed Rules for Implementing the Evaluation Standards for Tertiary Hospitals (2011 Edition) Weiban Yiguanfa [2011] No.148
[4] Beijing Medical Institution Medical Device Management System (Trial) Jingwei Yaojianzi [2012] 88
[5] Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices State Council Order No. 680
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