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YY 0784-2010: Medical electrical equipment. Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
YY 0784-2010
Medical electrical equipment.Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
ICS 11.040.55
C39
People 's Republic of China Pharmaceutical Industry Standard
YY 0784-2010/ISO 9919..2005
Medical electrical equipment Medical pulse oximetry equipment
Basic safety and major performance requirements
(ISO 9919..2005, IDT)
2010-12-27 release
2012-06-01 Implementation
State Food and Drug Administration issued
Directory
Preface Ⅴ
Introduction Ⅵ
1 range 1
2 normative reference document 1
3 Terms and definitions 2
4 General requirements and test requirements 6
Category 5
Identify, identify and document 7
7 Power supply 9
8 basic security type 9
10 Environmental conditions 9
No general requirements 9
No general requirements 9
13 Overview 9
14 Requirements for classification 10
15 limits of voltage and/or energy
16 housing and protective cover 10
17 Isolation 10
18 Protective earthing, functional grounding and potential equalization 10
19 continuous leakage current and patient auxiliary current 10
20 dielectric strength 10
21 * Mechanical strength 11
22 moving parts
23 side, angle and side 12
24 Stability during normal use 12
25 spatter 12
Vibration and noise
27 Pneumatic and hydraulic power 12
28 Suspended material 13
29 X-ray radiation 13
30 α, β, γ, neutron radiation and other particle radiation
31 microwave radiation 13
32 optical radiation (including laser) 13
YY 0784-2010/ISO 9919..2005
33 Infrared radiation 13
34 UV radiation 13
35 sound energy (including ultrasound) 13
36 * Electromagnetic compatibility 13
37 Location and basic requirements
38 mark, random file 14
39 Common requirements for AP and APG equipment 14
Requirements and tests for AP equipment and its components and components
Requirements and tests for APG - type equipment and their components and components
42 overtemperature 14
43 fire 15
44 overflow, liquid spill, leak, moisture, feed, cleaning, disinfection, sterilization and compatibility 15
45 pressure vessel and pressure receiving member 16
46 people are wrong 16
47 electrostatic charge 16
Biocompatibility 16
49 Power supply interruption 16
50 Accuracy of working data 17
51 Prevention of dangerous output 18
52 abnormal operation and fault state 19
Environmental Test 19
54 Overview 19
55 housing and cover 19
Components and components
57 power supply parts, components and wiring 20
58 protection ground --- terminal and connection 20
Structure and wiring
101 * Signal integrity 20
102 * pulse oximetry probe and probe extension line 20
103 saturation pulse information signal 21
104 alarm system
105 Appendix 21 to the General Standard
Appendix AA (informative) Basic principles 22
Appendix BB (informative) Temperature of blood oxygen probe in contact with skin 31
Appendix CC (informative) Accuracy 34
Appendix DD (informative) Calibration standard
Appendix EE (informative) Evaluation of SpO2 Accuracy on the Human Body 42
YY 0784-2010/ISO 9919..2005
Appendix FF (informative) Analogue, Calibrator and Function Tester for Pulse Oximeter 47
Appendix GG (informative) Concept of device response time
Appendix HH (informative) Basic principles Reference 59
Appendix II (informative) Environmental aspects 61
Reference 63
Index 67
YY 0784-2010/ISO 9919..2005
Preface
This standard is based on GB 9706.1-2007 "Medical electrical equipment Part 1. General requirements for safety" (common standard) of the special standard
Quasi, with GB 9706.1 supporting the use. The special standard is GB 9706.1-2007 "medical electrical equipment Part 1. safety general
Request "to modify and supplement.
This standard uses the translation method equivalent to ISO 9919..2005 "Medical Electrical Equipment Medical Pulse Oximeter Basic Safety and Main
To performance specific requirements ". This standard has made the following editorial changes to ISO 9919..2005.
--- reference standards, such as domestic has been transformed, will be directly into the domestic standards; if there is no conversion, follow the foreign standards, and the corresponding
The terms will not be required.
--- delete the original standard in the preparation of some of the instructions to increase the conversion of the editorial instructions.
This standard by the National Medical Electrical Standardization Technical Committee of medical electronic equipment standardization sub-technical committee (SAC/TC10/SC5)
Go back.
The drafting of this standard. Shenzhen Mindray Biomedical Electronics Co., Ltd., Guangdong Baolai Te Medical Technology Co., Ltd., Shanghai
City Medical Devices Testing Institute.
The main drafters of this standard. Zhang Xu, Li Tianbao, Gu Zhengyu, Ye Jilun.
YY 0784-2010/ISO 9919..2005
introduction
In many medical fields, pulse oximetry is widely used to estimate arterial oxygen saturation and pulse rate. This standard is equivalent
ISO 9919..2005, covering the basic safety and essential performance requirements of the existing technology.
Appendix AA contains the basic principles of some requirements, the submission of a request to the Commission and the verification of the risks that the request can handle
Reason for additional explanation.
Appendix BB is a literature survey of the highest safe temperature determination between the oxygen probe and the patient tissue contact surface.
Appendix CC discusses the evaluation formula for the oxygenation accuracy of the pulse oximeter device and the definition of these formulas.
Appendix DD provides guidance on when blood gas calibration should be performed on the pulse oximeter device.
Appendix EE presents a guideline for calibrating pulse oximetry equipment through controlled hypoxia studies.
Appendix FF is a guide to the use of pulse oximeters for a variety of subjects.
Appendix GG describes the concept of pulse oximeter device response time.
This standard is based on the specific standard GB 9706.1-2007, GB 9706.1-2007, then was designated as a common standard. Common standards
Is to ensure that all in the basic medical environment or in the use of qualified personnel under the supervision of medical equipment, the basic standards of safety, but also package
Including specific requirements for reliable operation to ensure safety.
Common standards have relevant side-by-side standards and specific standards. The juxtaposition criteria include requirements for specific technology and/or hazards
All applications such as medical systems, EMC, diagnostic X-ray equipment for radiation protection, software and so on. Special standards apply to specific equipment such as
Medical electronic accelerator, high frequency surgical equipment, beds and so on.
Note. The definitions of side-by-side standards and specific standards are described in 1.5 and A.2 of GB 9706.1-2007, respectively.
For the purposes of this standard, reference is made to the following agreement. For the parallel standard to supplement the GB 9706.1-2007 general standard
Change the content, specify the following rhetoric.
--- "Replacement" means that the terms and subclauses of the generic standard referred to are replaced by the contents of the special standard;
--- "Supplement" means that the relevant content of the standard (such as chapter, list elements, comments, tables, graphics) to the general standard
Quasi-request
- "Modification" means that a portion of the ex...