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YY 0784-2010

Chinese Standard: 'YY 0784-2010'
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YY 0784-2010English580 Add to Cart 0--15 minutes. Auto immediate delivery. Medical electrical equipment. Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use Valid YY 0784-2010
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Detail Information of YY 0784-2010; YY0784-2010
Description (Translated English): Medical electrical equipment. Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C39
Classification of International Standard: 11.040.55
Word Count Estimation: 78,762
Date of Issue: 2010-12-27
Date of Implementation: 2012-06-01
Quoted Standard: GB/T 2423.5-1995; GB/T 2423.8-1995; GB/T 2423.10-2008; GB/T 2423.56-2006; GB 4208-2008; GB/T 5332-2007; GB/T 5465.2-2008; GB 7247.1-2001; GB 9706.1-2007; GB 9706.15-2008; GB/T 19974-2005; YY 0466-2003; YY 0505-2005; YY/T 0708-2009; YY 0709-2009; IEC 60601-1-6-2004; IEC 60825-2-2000; ISO 14155-1-2003; ISO 14155-2-2003
Adopted Standard: ISO 9919-2005, IDT
Drafting Organization: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Administrative Organization: National Standardization Technical Committee of Medical electrical equipment
Regulation (derived from): State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies): China Food and Drug Administration
Summary: This standard specifies the use of human pulse oximeter equipment, basic safety and essential performance requirements for the device is included in the normal use of any necessary parts, such as pulse oximeter monitor, pulse oximeter probe, extension cable lines. These requirements also apply after reprocessing pulse oximeter equipment, including pulse oximeter monitors, oxygen probe and the probe cable lengths. Pulse oximeter equipment range of applications including, but not limited to, health care institutions and households in the estimated patient's arterial oxygen saturation and pulse rate. This standard does not apply to laboratory studies using pulse oximetry equipment, nor to be applied to the patient's blood samples collected oximeter. This standard does not apply to the fetus dedicated pulse oximeter devices. This standard does not apply to be placed on the outside of the patient environment display SpO2: numerical telemetry or master (from) device.

YY 0784-2010
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.55
C 39
YY 0784-2010 / ISO 9919.2005
Medical electrical equipment - Particular requirements
for the basic safety and essential performance of
pulse oximeter equipment for medical use
(ISO 9919.2005, IDT)
医用电气设备 医用脉搏血氧仪设备
基本安全和主要性能专用要求
ISSUED ON. DECEMBER 27, 2010
IMPLEMENTED ON. JUNE 1, 2012
Issued by. China Food and Drug Administration
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Table of Contents
Foreword ... 5 
Introduction ... 6 
1 Scope ... 8 
2 Normative references ... 8 
3 Terms and definitions ... 10 
4 General requirements and requirements for tests ... 16 
5 Classification ... 17 
6 Identification, marking and documents ... 17 
7 Power input ... 22 
8 Basic safety categories ... 22 
9 Removable protective means ... 22 
10 Environmental conditions ... 22 
11 Not used ... 22 
12 Not used... 22 
13 General ... 22 
14 Requirements related to classification ... 22 
15 Limitation of voltage and/or energy ... 23 
16 Enclosures and protective covers ... 23 
17 Separation ... 23 
18 Protective earthing, functional earthing and potential equalization ... 23 
19 Continuous leakage currents and patient auxiliary currents ... 23 
20 Dielectric strength ... 24 
21* Mechanical strength ... 24 
22 Moving parts ... 26 
23 Surfaces, corners and edges ... 26 
24 Stability in normal use ... 27 
25 Expelled parts ... 27 
26 Vibration and noise ... 27 
27 Pneumatic and hydraulic power ... 27 
28 Suspended masses ... 27 
29 X-Radiation ... 27 
30 Alpha, beta, gamma, neutron radiation and other particle radiation ... 27 
31 Microwave radiation ... 27 
32 Light radiation (including lasers) ... 27 
33 Infra-red radiation ... 28 
34 Ultraviolet radiation ... 28 
35 Acoustical energy (including ultrasonic) ... 28 
36* Electromagnetic compatibility ... 28 
37 Locations and basic requirements ... 29 
38 Marking, accompanying documents ... 29 
39 Common requirements for category AP and category APG equipment ... 29 
40 Requirements and tests for category AP equipment, parts and
components thereof ... 29 
41 Requirements and tests for category APG equipment, parts and
components thereof ... 29 
42 Excessive temperatures ... 29 
43 Fire prevention ... 30 
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning,
sterilization, disinfection and compatibility ... 31 
45 Pressure vessels and parts subject to pressure ... 32 
46 Human errors ... 32 
47 Electrostatic charges ... 32 
48 Biocompatibility ... 32 
49 Interruption of the power supply ... 33 
50 Accuracy of operating data ... 34 
51 Protection against hazardous output ... 37 
52 Abnormal operation and fault-conditions ... 38 
53 Environmental tests ... 38 
54 General ... 38 
55 Enclosures and covers ... 38 
56 Components and general assembly ... 38 
57 Mains parts, components and layout ... 38 
58 Protective earthing - Terminals and connections ... 38 
59 Construction and layout ... 38 
101* Signal inadequacy ... 39 
102* Pulse oximeter probes and probe cable extenders ... 39 
103 Saturation pulse information signal ... 40 
104 Alarm systems ... 40 
105 Appendices of the general standard ... 41 
Annex AA (Informative) Rationale ... 42 
Annex BB (Informative) Skin temperature at the pulse oximeter probe ... 58 
Annex CC (Informative) Determination of accuracy ... 63 
Annex DD (Informative) Calibration standards ... 75 
Annex EE (Informative) Guideline for evaluating and documenting SpO2
accuracy in human subjects ... 77 
Annex FF (Informative) Simulators, calibrators and functional testers for pulse
oximeter equipment ... 87 
Annex GG (Informative) Concepts of equipment response time ... 99 
Annex HH (Informative) Reference to the essential principles ... 104 
Annex II (Informative) Environmental aspects ... 107 
Bibliography ... 109 
Index ... 113 
Introduction
The approximation of arterial haemoglobin saturation and pulse rate using
pulse oximetry is common practice in many areas of medicine. This Standard
identically uses ISO 9919.2005, co......
Related standard:   YY 0781-2010  YY 0782-2010
   
 
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