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YY 9706.234-2021: (Medical electrical equipment - Part 2-34: Specific requirements for basic safety and basic performance of invasive groundwater equipment)
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(Medical electrical equipment - Part 2-34: Specific requirements for basic safety and basic performance of invasive groundwater equipment)
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YY 9706.234-2021
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Basic data | Standard ID | YY 9706.234-2021 (YY9706.234-2021) | | Description (Translated English) | (Medical electrical equipment - Part 2-34: Specific requirements for basic safety and basic performance of invasive groundwater equipment) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C39 | | Word Count Estimation | 53,514 | | Issuing agency(ies) | State Drug Administration | YY 9706.234-2021: (Medical electrical equipment - Part 2-34: Specific requirements for basic safety and basic performance of invasive groundwater equipment)
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(Medical electrical equipment Part 2-34.Specific requirements for basic safety and basic performance of invasive groundwater equipment)
ICS 11.040.55
C39
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0783-2010
Medical Electrical Equipment Part 2-34.Invasive Blood Pressure
Particular requirements for basic safety and basic performance of monitoring equipment
(IEC 60601-2-34.2011, MOD)
Published on 2021-09-06
2024-05-01 Implementation
Released by the State Drug Administration
directory
Preface III
Introduction IV
201.1 Scope, Purpose and Related Criteria1
201.2 Normative References 2
201.3 Terms and Definitions 2
201.4 General Requirements 3
201.5 General Requirements for ME EQUIPMENT Testing 3
201.6 Classification of ME EQUIPMENT and ME SYSTEM 4
201.7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENT 4
201.8 ME EQUIPMENT PROTECTION TO ELECTRIC SHOCK HAZARD 6
201.9 Protection of me equipment and me systems against mechanical hazards 12
201.10 Protection against unwanted and excessive radiation hazards 13
201.11 Protection against overtemperature and other hazards 13
201.12 Accuracy of controllers and instruments and protection of hazardous outputs 15
201.13 Hazardous and fault conditions 19
201.14 Programmable Medical Electrical System (PEMS) 20
201.15 Structure of ME equipment 20
201.16 ME System 21
201.17 Electromagnetic compatibility of me equipment and me systems 21
202 Electromagnetic Compatibility --- Requirements and Tests 21
202.6 Electromagnetic compatibility 21
208 General requirements, tests and guidelines for alarm systems in medical electrical equipment and medical electrical systems 27
208.6 Alarm systems 27
Addendum 34
Appendix AA (Informative Appendix) Specific Guidelines and Principles 35
Appendix BB (informative appendix) Alarm legend 208/YY 9706.108-2021 45
Reference 47
Figure.201.101 Dynamic Test for Energy Confinement of Different Sections - Recovery Test 7
Figure.201.102 Diaphragm leak test 8
Figure.201.103 Patient Leakage from Patient Connection to Ground through Type F Applied Parts Caused by Extraneous Voltage on the Patient Connection
Current measurement circuit 9
Figure.201.104 ME EQUIPMENT CLASS I from applied parts to
Measurement circuit 10 of patient leakage current to ground
Figure.201.105 Slave application of internally powered ME EQUIPMENT caused by extraneous voltage on unprotected earthed metal accessible parts
Measurement circuit for partial-to-ground patient leakage current 11
Figure.201.106 Description of leakage current test 12
Figure.201.107 Overvoltage test 13
Figure.201.108 Test 16 for Pressure Measurement Accuracy
Figure.201.109 Test Sequence for Sensitivity, Repeatability, Nonlinearity, Drift and Hysteresis 17
Figure.201.110 Pressure Measurement System for Systolic and Diastolic Accuracy 18
Figure.201.111 Frequency Response of ME Equipment and Sensors 19
Figure 202.101 Test Layout for Conducted Emissions, Radiated Emissions and Radiated Immunity 22
Figure 202.102 Test circuit for high frequency surgical interference measurement when applied part isolation in the monitor 25
Figure 202.103 Test circuit for high-frequency surgical protection when applying partial isolation in the sensor 26
Figure 202.104 Test layout for high-frequency surgical protection 27
Figure 208.101 Delay time test for an alarm signal indicating a physiological alarm state 31
Figure 208.102 Delay time test for an alarm signal indicating a physiological alarm state 32
Figure AA.1 Error range of pressure sensor 40
Figure BB.1 Non-latching alarm signal without alarm reset 45
Figure BB.2 Non-latching alarm signal with alarm reset 45
Figure BB.3 Latch alarm signal with alarm reset 46
Figure BB.4 Two alarm states with alarm reset 46
Table.201.101 Basic performance requirements 3
TABLE 208.101 ALARM STATUS PRIORITIES FOR ME EQUIPMENT 28 FOR PATIENTS THAT ARE NOT EXPECTED MONITORING THE CLINICAL OPERATOR
Table 208.102 Characteristics of the audible alarm signal burst, for patients who are not expected to monitor the clinical operator's continued attention
ME equipment 28
foreword
All technical content in this section is mandatory.
The "Medical Electrical Equipment" series of standards is divided into two parts.
--- Part 1.General and side-by-side requirements;
--- Part 2.Specific requirements.
This part is part 2-34.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY 0783-2010 "Medical Electrical Equipment Part 2-34.Safety and Basic Performance of Invasive Blood Pressure Monitoring Equipment"
Special Requirements". The main technical differences between this part and YY 0783-2010 are as follows.
--- Increased the requirements for basic performance (see.201.4.3.101);
--- Added the requirement for alarm reset (see 208.6.9);
--- Modified some test methods and test circuits (see.201, 208).
This part uses the redrafted method to modify and adopt IEC 60601-2-34.2011 "Medical Electrical Equipment Part 2-34.Invasive Blood Pressure Monitoring
Particular requirements for basic safety and basic performance of protective equipment.
The technical differences between this part and IEC 60601-2-34.2011 and their reasons are as follows.
--- Regarding normative reference documents, this part has made adjustments with technical differences to adapt to the technical conditions of our country and the circumstances of the adjustment.
The situation is reflected in Chapter 2 "Normative References", and the specific adjustments are as follows.
● Replacing IEC 60601-1-2.2007 with YY 9706.102-2021 which has been modified to adopt the international standard;
● Replacing IEC 60601-1-8.2006 with YY 9706.108-2021 which has been modified to adopt the international standard;
● Replace IEC 60601-2-2.2009 with GB 9706.4 which is equivalent to adopting international standards;
● Deleted IEC 60601-2-27;
● Deleted IEC 60601-2-49;
● Replace IEC 60529 with GB/T 4208-2017 which is equivalent to adopting international standards.
The following editorial changes have been made to this section.
--- Removed the index to IEC 60601-2-34.2011.
Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents.
This part is proposed by the State Drug Administration.
This part is approved by the National Medical Electrical Equipment Standardization Technical Committee Medical Electronic Instrument Standardization Sub-Technical Committee (SAC/TC10/SC5)
focal point.
This section is drafted by. Shenzhen Mindray Biomedical Electronics Co., Ltd., Shanghai Medical Device Testing Institute.
The main drafters of this section. Cen Jian, Tao Hua, Zhang Jun, Feng Guangzhou, Jia Zhiyu, Han Fei.
The previous versions of the standards replaced by this part are as follows.
---YY 0783-2010.
Introduction
This section deals with the basic safety and basic performance of invasive blood pressure monitoring equipment. This part modifies and supplements GB 9706.1-2020
"Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Essential Performance" (hereinafter referred to as the general standard).
The purpose of this third edition is to update this part with reference to the third edition of the Common Standard through format modifications and technical changes.
The requirements of this section take precedence over the general standard.
A "General Guidance and Rationale" for the more important requirements of this part is contained in Appendix AA. Chapters with an asterisk (*) in this section
And the relevant principles are explained in Appendix AA. We believe that an understanding of these requirements not only facilitates the correct application of this standard, but also
The process of revising the standard due to changes in clinical practice or technological development is accelerated from time to time, however, Annex AA is not a requirement of this standard.
part.
Medical Electrical Equipment Part 2-34.Invasive Blood Pressure
Particular requirements for basic safety and basic performance of monitoring equipment
201.1 Scope, Purpose and Related Standards
Clause 1 of the general standard 1) applies, except for the following.
1) The general standard is GB 9706.1-2020 "Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Basic Performance".
201.1.1 *Scope
replace.
This part specifies the basic safety and basic performance of invasive blood pressure monitoring equipment (hereinafter referred to as ME equipment).
This section applies to invasive blood pressure monitoring equipment including related sensors for internal measurement or monitoring of circulatory system pressure.
This section does not apply to puncture catheters, puncture needles, Luer connectors, stopcocks, and stopcock tables for connecting pressure-transmitting diaphragms.
This section does not apply to non-invasive blood pressure monitoring devices.
201.1.2 Purpose
replace.
The purpose of this section is to develop requirements for the essential safety and essential performance of invasive blood pressure monitoring devices as defined in.201.3.63.
201.1.3 Tied standards
Replenish.
This section refers to Chapter 2 of the General Standard and the applicable collateral standards listed in.201.2 of this section.
YY 9706.102-2021 and YY 9706.108-2021 apply after amendments in Chapter 202 and Chapter 208 respectively. GB 9706.103-
2020 does not apply.
201.1.4 Particular standards
replace.
Particular standards may modify, replace or delete requirements contained in general or collateral standards to apply to the ME EQUIPMENT under consideration, and also
Additional essential safety and essential performance requirements may be added.
Requirements of specific standards take precedence over general standards.
GB 9706.1 is referred to as the general standard in this part. Collateral standards are indicated by their standard numbers.
The numbering of chapters and articles in this part corresponds to the general standard by prefixing "201" (for example,.201.1 in this part corresponds to the general standard
Chapter 1), or by prefixing "20x" with the applicable collateral standard, where x is the corresponding International Standard number of the collateral standard
(for example, 202.4 in this section corresponds to the international standard IEC 60601-1-2 corresponding to the collateral standard YY 9706.102-2021.
The content of Chapter 4 in.2007, 203.4 in this part corresponds to the international standard IEC 60601-1-3 corresponding to the parallel standard GB 9706.103.
Chapter 4, etc.). For changes to the general standard text, the following terms are specified.
"Replacement" means that the chapters and clauses of the General Standard or applicable Concurrent Standard are completely replaced by the provisions of this Part.
"Supplement" means that the provisions of this part supplement the requirements of the General Standard or the applicable Concurrent Standard.
"Modification" means the modification of the general standard or the chapters and clauses of the applicable collateral standard in accordance with the description of the provisions of this part.
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