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Medical electrical equipment. Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipments
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Basic data | Standard ID | YY 0783-2010 (YY0783-2010) | | Description (Translated English) | Medical electrical equipment. Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipments | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C39 | | Classification of International Standard | 11.040.55 | | Word Count Estimation | 46,419 | | Date of Issue | 2010-12-27 | | Date of Implementation | 2012-06-01 | | Adopted Standard | IEC 60601-2-34-2000, IDT | | Regulation (derived from) | State Food and Drug Administration Notice 2010 No. 97 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard applies to the definition of the 2. 101 invasive blood pressure monitoring and measurement equipment, hereinafter referred to as the device. This standard does not apply to special puncture catheter, needle, Ruhr (Luer) fittings, stopcock and stopcock workbench. The specific standard does not apply to non-invasive blood pressure monitoring equipment. | YY 0783-2010: Medical electrical equipment. Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipments
---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.
Medical electrical equipment.Part 2-34. Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipments
ICS 11.040.55
C39
People's Republic of China pharmaceutical industry standards
YY 0783-2010/IEC 60601-2-34.2000
Medical electrical equipment - Part 2-34.
Invasive blood pressure monitoring equipment and security
Essential performance
Part 2-34. Particularrequirementsforthesafety, includingessentialperformance,
(IEC 60601-2-34.2000, IDT)
Issued on. 2010-12-27
2012-06-01 implementation
State Food and Drug Administration issued
Table of Contents
Introduction Ⅲ
Introduction Ⅳ
The first chapter Overview 1
1. Scope and purpose 1
2 Terms and definitions 1
4 General test requirements 3
5 Category 3
6 Identification, marking and documents 3
The second environmental conditions 4
Third of the risk of electric shock protection 4
Requirements concerning classification 4 14
17 Isolated 4
19 Continuous leakage currents and patient auxiliary current 4
20 Dielectric strength 5
Title IV of the mechanical hazards Protection 5
21 Mechanical strength 5
The fifth chapter of unwanted or excessive radiation hazard protection 6
36 Electromagnetic compatibility 6
Title VI of flammable anesthetic mixture ignition hazard protection 7
Title VII of the overtemperature protection and other safety hazards 7
42 overtemperature 7
44 overflow, liquid spill, leak, damp, into the liquid, cleaning, disinfection, sterilization and compatibility 8
45 pressure vessels and pressure parts 8
46 human error 8
Accuracy, and to prevent the risk of the output data of the eighth chapter of the work 9
9 50 Operating data accuracy
Prevent dangerous output of 9 51
Chapter 9. abnormal operation and fault conditions; environmental testing 15
Tenth Canto structural requirements 15
56 components and assembly 15
Net power supply section 57, components and wiring 15
Relevant guidelines Annex AA (informative) special clauses and basic principles 30
Appendix BB (informative) alert legend 36
References 39
Index 40
101 through F-type ground (floating) patient leakage current is measured by the circuit 16 is applied to the application part of the external voltage caused
102 energy to different parts of the restricted dynamic test [see the professional standard 17h) a)] --- Recovery Test (see 51.101) 17
YY 0783-2010/IEC 60601-2-34.2000
From the application to be part of the patient graphs 103 Ⅰ applied to the device due to functional ground terminal of the external voltage generated leakage current measurement
Circuit 18
Figure 104 Internal powered equipment due to ground from the application part of the patient plus functional ground terminal external voltage generated leakage current measurement circuit
(See 19.3) 19
105 leakage current test instructions (see General Standard 19.4 and 21) 20
106 Diaphragm leakage test (see 17.101.1) 21
107 Overvoltage test (see 45.101) 21
108 conducted emissions, radiated emissions and radiated immunity test layout (see 36.201.1.7,36.202,36.202.2) 22
When 109 patients in isolation monitor, the high frequency surgical interference measurement test circuit (see 36.202.7) 22
Fig. 110 When patients in isolation monitor, the high frequency surgical interference measurement test circuit (see 36.202.7) 23
111 high-frequency surgical interference test layout (see 36.202.7) 24
112 pressure measurement accuracy of the test (see 51.102.1) 25
113 sensitivity, reproducibility, linearity, drift and hysteresis tests (see 51.102.1) 26
114 systolic and diastolic blood pressure measurement accuracy of the system (see 51.102.2) 27
Frequency 115 corresponding devices and sensors (see 51.103) 28
116 alarm delay test (see 51.207.3) 29
117 alarm delay test (see 51.207.3) 29
Figure AA.1 input error function of pressure range 35
YY 0783-2010/IEC 60601-2-34.2000
Foreword
All the technical content of this specific standard is mandatory.
Medical electrical equipment standard series of standards, the series standard consists of two parts.
--- Part 1. General requirements for safety of medical electrical equipment;
--- Part 2. Medical electrical equipment requirements for the safety.
This special standard - Part 2-34 Medical electrical equipment. This standard is based on GB 9706.1-2007 "Medical electrical equipment - Part 1
Part I. General Requirements for Safety "(General Standard) of the specific standards, and supporting the use of GB 9706.1. This is a specific standard GB 9706.1-2007
"Medical Electrical Equipment Part 1. General requirements for safety" of changes and additions.
The use of specific standard translation method identical with IEC 60601-2-34.2000 "Medical electrical equipment - Part 2. invasive blood pressure monitoring
Equipment safety and essential performance. "
The specific standard IEC 60601-2-34.2000 made the following editorial changes.
--- Use the decimal symbol instead of the international standard in decimal notation ",". ",";
--- Other international standards quoted in the standard, if it has the appropriate standards into our country, places of reference standards prevail;
--- Remove IEC 60601-2-34.2000 cover and foreword, according to GB/T 1.1-2009 asked to re-write;
--- By IEC 60601-2-34.2000 Electromagnetic compatibility in part of IEC 60601-1-2.1993 Edition, press YY 0505-
2005 (identical with IEC 60601-1-2.2001) of Clause No. editorial changes.
The specific standard Chapter 36 Electromagnetic Compatibility YY 0505-2005 "Medical electrical equipment - Part 1-2. General requirements for safety and
Standard column. EMC requirements and tests "implemented simultaneously.
The specific standard of medical equipment by the National Standardization Technical Committee of Standardization Technical Committee of Medical Appliances (SAC/TC10 /
SC5) centralized.
The specific standard drafting unit. Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shanghai Medical Device detection.
The main drafters of this specific standard. Liu Yunfeng, Zhang Yi Dong, Ye Jilun.
YY 0783-2010/IEC 60601-2-34.2000
Introduction
General Standard does not include "direct blood pressure monitoring equipment," the safety and essential performance requirements. Therefore, we need to make changes to cover
Cover these special requirements. The specific standard considers the collateral standard YY 0505-2005 electromagnetic compatibility, and standard parallel
YY/T 0708-2009 Medical electrical equipment with programmable electrical system. It also includes a chapter on the alarm strip, since the alarm
One of the functions of monitoring equipment is required.
YY 0783-2010/IEC 60601-2-34.2000
Medical electrical equipment - Part 2-34.
There is safety and essential performance of invasive blood pressure monitoring equipment requirements for
The first chapter outlines
Except as follows General Standard clauses apply to this Title.
1 Scope and purpose
Except as follows, common standards in this chapter apply.
1.1 Scope *
This standard applies to specific defined in 2.101 invasive blood pressure monitoring and measurement equipment, hereinafter referred to as the device.
This standard does not apply to special catheter, needle, Luer (Luer) fittings, stopcock and stopcock table.
This standard does not apply to special non-invasive blood pressure monitoring equipment.
1.2 Purpose
replace.
The aim is to develop specific standard as basic requirements for safety and performance of the equipment as defined in 2.101.
1.3 Specific Standard
Addition.
The specific reference to the standard GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety."
General standards include YY 0505-2005 "Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility
Requirements and testing ", as well as IEC 60601-1-4.1996" Medical electrical equipment - Part 1-4. General requirements for safety - Collateral standard. Programmable
Cheng electrical medical equipment. "
GB 9706.1-2007 standard referred to as "General Standard" or "General requirements" in this specific standard.
The specific standard parts, chapters, bars and common standards corresponding parts, chapters, strip the same. The specific standard provisions of the General Standard change
Change, specify the text represented by the following.
"Replace" means the General Standard or chapter shall be completely replaced in this specific standard provisions.
"Supplement" refers to the contents of this specific standards to common standards requirements.
"Modify" refers to the content of the common standards chapter or modify specific standard expressed as cost.
Added to the General Standard and reg, numbered starting from 101, with the addition of the Appendix AA, BB, etc. No, but the addition of the item with the
aa), bb) and other numbers.
The term "this standard" is used to refer to both the General Standard and this Particular Standard.
With an asterisk (*) marked reg expressed related to the principles described in Appendix AA or BB in the appendix. Understanding these requirements established by the original
Because it will help ensure proper application of standards, and in the case of technical progress due to changes in clinical practice or in the environment must also have to be amended
The Help.
When this is not related to the specific standard parts, chapters, Article, common standard articles, chapters, no modification shall be applied directly, although it may not be phase
turn off. If this standard has dedicated special instructions not used, then any part of the General Standard is not executed, although it may be relevant.
The specific requirements of the standard than the standards mentioned indirect common standards and above the relevant requirements have higher priority.
2 Terms and definitions
Except as follows, common standards in this chapter apply.
YY 0783-2010/IEC 60601-2-34.2000
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