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YY/T 1481-2016: Guide for the check of Ultrasonic Doppler fetal monitor
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Guide for the check of Ultrasonic Doppler fetal monitor
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YY/T 1481-2016
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Basic data | Standard ID | YY/T 1481-2016 (YY/T1481-2016) | | Description (Translated English) | Guide for the check of Ultrasonic Doppler fetal monitor | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C41 | | Word Count Estimation | 10,140 | | Date of Issue | 2016-07-29 | | Date of Implementation | 2017-06-01 | | Quoted Standard | YY/T 0841-2011 | | Regulation (derived from) | State Food and Drug Administration Notice 2016 (No.129) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the technical requirements, test methods and test results for the use of Ultrasound Doppler Fetal Monitor (hereinafter referred to as "Equipment"). The methods described in this standard are used to assist the user of the equipment to verify the performance of such equipment, mainly for medical practitioners, biomedical engineers, medical physicists, medical device maintenance personnel, professional testers, inspection bodies, or manufacturers The The reference to safety is performed with reference to YY/T 0841-2011. | YY/T 1481-2016: Guide for the check of Ultrasonic Doppler fetal monitor---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.
Guide for the check of Ultrasonic Doppler fetal monitor
ICS 11.040.50
C41
People's Republic of China Pharmaceutical Industry Standard
Ultrasound Doppler Fetal Monitor Verification Guide
2016-07-29 released
2017-06-01 implementation
State Food and Drug Administration issued
Directory
Preface I
Introduction II
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
4 Verification 1
5 Test methods 3
Appendix A (informative) Type of test description 5
Appendix B (Informative Appendix) Inspection Record Form 6
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Medical Electrical Standardization Technical Committee of medical ultrasound equipment standardization sub-technical committee (SAC/TC10/SC2)
Go back.
The drafting unit. the State Food and Drug Administration Hubei Medical Device Quality Supervision and Inspection Center.
The main drafters of this standard. Jiang Shilin, Wang Zhijian, Chen Rui.
Introduction
The purpose of this standard is for medical institutions in use of ultrasound Doppler fetal monitor performance verification, the establishment of standardized methods,
Technical requirements and test methods provide guidance.
To ensure that the ultrasound Doppler fetal monitor in a normal state of use, the need for regular verification. This standard specifies the acceptance check
Inspection and periodic inspection of two forms of verification. Receive inspection check the performance of the equipment at the time of delivery and/or equipment repair; the cycle check is performed at the manufacturer
The required time intervals to carry out the verification; according to the different cycles can have different verification content. This standard also provides periodic inspection reports
Of the example.
The usual cycle test is undertaken by the tester of the medical institution. Receive the test, the longer the interval of the cycle test by the skilled testers,
Such as biomedical engineers, medical physicists, medical device maintenance personnel, professional testers, inspection bodies, or manufacturers.
Ultrasound Doppler Fetal Monitor Verification Guide
1 Scope
This standard specifies the technical requirements, test methods and test results of the Ultrasound Doppler Fetal Monitor (hereinafter referred to as "Equipment").
The expression of the fruit.
The method described in this standard is used to assist the user of the equipment to verify the performance of such equipment, mainly for medical practitioners, biomedical
Engineers, medical physicists, medical equipment maintenance personnel, professional testers, inspection agencies, or manufacturers. Part of the safety involved
According to YY/T 0841-2011 implementation.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
YY/T 0841-2011 Medical electrical equipment Medical electrical equipment Periodic testing and post-repair testing
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Testers tester
After professional training, with the appropriate qualifications, authorized to carry out performance testing equipment or testing personnel, including medical practitioners, students
Medical engineers, medical physicists, medical equipment maintenance personnel, professional testers, inspection agencies, or manufacturers.
3.2
Reference value
The value used to evaluate the subsequent measurements.
The data of the periodic test is compared with the reference number to determine whether the device is in normal working condition.
Note 1. The result of the equipment acceptance test can be used as a reference value after the new or restored equipment.
Note 2. Change from 3.30 in YY/T 0841-2011.
3.3
Check check
System actions to ensure the safety and effectiveness of medical equipment, including acceptance testing and periodic inspection.
4 Verification
4.1 acceptance test
4.1.1 Perform the first test after the equipment is delivered to the user, verifying the performance of the equipment at the time of delivery and/or equipment repair.
4.1.2 The contents of the test shall include at least the contents of the annual inspection in addition to the contract.
4.1.3 Test results of the receiving test as a reference for the performance of the equipment (see Appendix A).
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