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Medical electrical equipment. Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
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YY 0784-2010: PDF in English 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 existing text of the common standard is made by deletion or addition in accordance with the textual requirements of this special standard
change.
In order to avoid confusion with the self-revision of the common standard, the new elements of this standard have a special numbering method. chapter,
The bar, table and graphic numbers start at 101. Additional list items using the letters aa), bb), etc., the increase in the appendix letters AA, BB and so on.
In this special standard, the basic principles listed in Appendix AA are identified by the asterisk "*".
YY 0784-2010/ISO 9919..2005
Medical electrical equipment Medical pulse oximetry equipment
Basic safety and major performance requirements
1 Scope
Reference to Chapter 1 of GB 9706.1-2007 does not include the following.
Modify (at the end of 1.1)
This standard describes in detail the specific safety and essential performance requirements for pulse oximetry equipment suitable for use in humans.
Including any necessary components in normal use, such as pulse oximetry, pulse oximetry, probe cable extension cord, and so on.
These requirements also apply to reprocessed pulse oximetry equipment, including pulse oximetry, oximetry and probe cable extension
Line and so on.
The range of application of the pulse oximeter device includes, but is not limited to, estimating arterial oxygen saturation in a patient in a health care facility and in a home
Degree and pulse rate.
This standard does not apply to pulse oximetry equipment used in laboratory studies and is not applicable to blood oxygen meters where blood samples are to be collected.
This standard does not apply to fetal pulse oximeter equipment.
This standard does not apply to telemetry or master (slave) devices that display SpO2 values outside the patient's environment.
The requirements of this standard replace or modify GB 9706.1-2007 and are expected to take precedence over the corresponding general requirements.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, the only dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 2423.5-1995 Environmental testing for electric and electronic products - Part 2. Test methods - Test Ea and guidance. Impact
(IEC 68-2-27. 1987, IDT)
GB/T 2423.8-1995 Environmental testing for electric and electronic products - Part 2-32. Test method test Ed. Free fall
(IEC 68-2-32..1990, IDT)
GB/T 2423.10-2008 Environmental testing of electric and electronic products - Part 2-6. Test. Fc test Vibration (positive rotation curve)
(IEC 60068-2-6..1995, IDT)
GB/T 2423.56-2006 Environmental testing for electric and electronic products - Part 2-64. Test methods - Test Fh. Broadband random vibration
(Digital control) and guidelines (IEC 60068-2-64..1993, IDT)
GB 4208-2008 enclosure protection class (IP code) (IEC 60529..2001, IDT)
Test method for ignition temperature of flammable liquids and gases (IEC 60079-4. 1975, IDT) GB/T 5332-2007
Graphical symbols for electrical equipment - Part 2. Graphical symbols (IEC 60417DB..2007, IDT) GB/T 5465.2-2008
GB 7247.1-2001 Safety of laser products - Part 1. Classification, requirements and user guidance for equipment (IEC 60825-1..1993,
IDT)
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)
GB 9706.15-2008 Medical electrical equipment - Part 1-1. General requirements for safety - Side standard. Medical electrical system safety
(IEC 60601-1-1..2000, IDT)
GB/T.19974-2005 Characteristics of Sterilization and Sterilization of Health Care Products and Establishment of Sterilization Process for Medical Devices
General requirements for regulatory control (ISO 14937..2000, IDT)
YY 0784-2010/ISO 9919..2005
YY 0466-2003 Medical equipment may be used for medical equipment trademarks, labels and symbols for providing information (ISO 15223-2000,
IDT)
YY 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety - Parallel standards. Electromagnetic compatibility requirements and tests
(IEC 60601-1-2..2001, IDT)
Medical electrical equipment - Part 1-4. Safety - General requirements - Parallel standard. Programmable medical electrical systems
(IEC 60601-4..2000, IDT)
Medical electrical equipment - Part 1-8. Safety - General requirements - Side standard. Medical electrical equipment and medical equipment
Testing and Guidance for Alarm Systems in Air Systems (IEC 60601-1-8..2006, IDT)
IEC 60601-1-6..2004 Medical electrical equipment - Part 1-6. Safety, general requirements, tied for standards. availability
IEC 60825-2..2000 Laser product safety - Part 2. Optical fiber communication system security (OFCS)
Medical equipment - Clinical study - Part 1. General requirements ISO 14155-1..2003
Medical equipment - Clinical studies - Part 2. Clinical research plan ISO 14155-2..2003
3 terms and definitions
For the purpose of this standard, the terms and definitions given in Chapter 2 of GB 9706.1-2007 are made in parallel
Modify the following applies.
Note. For the sake of convenience, all the terms used in this standard are defined in Appendix JJ.
3.1
Accuracy
The degree of agreement between the test results and the accepted reference values.
Note 1. see 50.101.2.2 pulse oximeter equipment, the accuracy of the calculation method.
Note 2. See also Appendix CC for discussion.
Note 3. quoted from GB/T 3358.1.
3.2
Controlled hypoxia saturation control controldesdesurationuration
In the laboratory conditions for the human body induced by hypoxia.
Note. Also known as controlled hypoxia (respiratory limitation) studies. See Annex EE.
3.3
Carbon monoxide - Blood gas analyzer CO-oximeter
Multi-wavelength, optical blood gas analyzer, can measure the total hemoglobin concentration and a variety of hemoglobin derivatives concentration.
Note. The carbon monoxide-blood gas analyzer-related measurements are functional saturation of the arterial blood, ie SaO2, while the pulse oximetry is estimated and reported to SpO2.
3.4
Data update period dataupdateperiod
The algorithm of the pulse oximeter device provides a time interval for new valid data to the display or signal output port.
Note. This definition does not refer to the displayed refresh period, and the typical value of the display refresh period is 1s, not the time interval defined above (generally longer).
3.5
Claim scope
Refers to the pulse oxygen saturation (SpO2) and the pulse rate value of the display range (3.7) in the clear part of the accuracy.
3.6
Demonstration mode demonstrationmode
A pattern that shows simulated patient data or patient waveforms.
Note. If there is no proper indication, the data displayed in the demo mode may be mistaken for the patient's real-time recording data.
YY 0784-2010/ISO 9919..2005
3.7
Display range displayed range
The pulse oximetry device can display the range of pulse oximetry (SpO2) and pulse rate values.
Note. This range can exceed the claimed range (3.5).
3.8
Partial saturation fractionaloxyhaemoglobinfractionalsaturation
FO2Hb
Oxygenated hemoglobin concentration cO2Hb and hemoglobin total concentration ctHb ratio.
Note 1. expressed as a mathematical expression. FO2Hb = cO2HbctHb
Where.
CO2Hb - oxygenated hemoglobin concentration;
CtHb --- total hemoglobin concentration.
This formula sometimes appears as a percentage (multiplied by 100).
Note 2. Partial oxycyclotin is a term used by the National Committee for Clinical Laboratory Science (NCCLS) for this ratio.
Note 3. NCCLS uses the prefix c to denote "concentration", which was used in square brackets, such as [O2Hb].
Note 4. NCCLS uses the following symbols.
Oxygenated hemoglobin (O2Hb);
--- deoxyhemoglobin (HHb);
--- carboxyhemoglobin (COHb);
Methemoglobin (MetHb);
--- sulfur hemoglobin (SuHb);
The total amount of hemoglobin (tHb).
3.9
Functional oxygen saturation functionaloxygensaturation
Oxygenated hemoglobin concentration divided by the sum of the oxygenated hemoglobin concentration and the deoxyhemoglobin concentration.
Note 1. expressed as a mathematical expression.
100 cO2Hb
CO2Hb cHHb
Note 2. NCCLS defines this ratio as functional oxygen saturation, symbolic representation of SO2.
3.10
Functional tester
Providing a signal with a predictive ratio (3.22) for the pulse oximeter device so that the tester can observe the display of blood oxygen values,
And a test device that compares the expectations on the calibration curve developed by the manufacturer for this oximeter device.
Note. The pulse oximeter device provides the accuracy of the oxygen value in a certain procedure depending on whether the blood oxygen monitor's calibration curve is compared with the oxygen probe and probe-
The optical properties of the interaction of the interface are consistent. Functional test instrument can not prove the calibration curve of blood oxygen accuracy, can not fully assess blood oxygen
The optical characteristics of the probe to determine the correctness of the calibration. See also chapter FF.4.
3.11
Local deviation localbias
The difference between the oxygen test value (SpO2) and the accepted reference value (SaO2).
Note 1. For pulse oximeter devices, this means that for a given reference value for oxygen saturation, the corresponding y value on the regression curve is proportional to the relative
The difference between the corresponding y values on the equivalent curve of the multiple oxygen measurements of SR, or expressed as.
Bi = SpO2fit, i-SRi
YY 0784-2010/ISO 9919..2005
Where.
SpO2fit, i - The value corresponding to the i-th oxygen saturation reference value SRi on the test data fitting curve.
Note 2. See also the mean deviation (3.13) and the discussion in Appendix CC.
Note 3. cited in ISO 3534-1..1993.
3.12
Manufacturer manufacturer
The design, production, packaging, and application of the pulse oximeter device, the oxygen monitor, the oxygen probe, the probe extension cord or the adapter
Work, sale and the preparation of random documents are responsible for the natural or legal person, whether these operations are completed by their own or by the benefit
The third party of the relationship is completed.
Note. quoted from IEC /CDV260601-1..2004, defined 3.54.
3.13
Mean difference meanbias
The mean difference between the test value and the reference value, leaving the symbol.
Note 1. For pulse oximeters, a mathematical expression is described as.
B =
I = 1
(SpO2i-SRi)
Where.
N - the number of samples in the area of interest;
SpO2i --- ith pulse oxygen saturation value;
SRi --- reference value for the i-th oxygen saturation.
Note 2. See also discussion of local deviations (3.11) and Appendix CC.
Note 3. When this method is used, this mean difference is the average of all local deviations.
3.14
Normalized normalized
Does not depend on the actual amplitude of the displayed signal, but is displayed at the same amplitude.
3.15
Operator settings Operatorettings
The current status of any control item of the pulse oximeter, including the alarm setting item.
3.16
Precision precision
The degree of agreement between the independent test results obtained under the specified conditions.
Note 1. For pulse oximeter equipment, it can be expressed as the remaining standard deviation, ie Sres, described as a mathematical expression.
Sres =
I = 1
(SpO2i-SpO2fit, i) 2
(N-2)
Where.
N - the number of data pairs in the area of interest;
(SpO2i-SpO2fit, i) is the difference between the i-th SpO2 value and the value on the fitting curve (corresponding to the ith reference saturation value).
Note 2. See also Appendix CC for discussion.
Note 3. cited in ISO 3534-1..1993.
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3.17
Probe cable extension cord probecableextender
Used to connect the pulse oximeter to the oxygen probe.
Note 1. Not every pulse oximeter device uses a cable extension cable for the probe.
Note 2. The probe cable extension cord can be used as part of the application.
3.18
Pulse oximetry device pulseoximeterequipment
The pulse oximeter device is the interaction between the optical signal and the tissue and the use of pulsating blood flow to cause tissue optical properties to depend on
, A non-invasive medical device for estimating arterial oxygen saturation (SpO2).
Note 1. The pulse oximeter device includes a pulse oximetry monitor, a probe extension cable (if provided), and a blood oxygen probe, where the cable extends
Long lines and blood oxygen probes can be combined into a single component.
Note 2. Technically, the light here can be seen as electromagnetic radiation (optical radiation). This standard uses generic terms.
3.19
Pulse oximetry
Is part of the pulse oximeter device, including electronic components, display unit and user interface. Does not include pulse oximetry and probe extension cord.
Is part of the pulse oximeter device, including electronic components, display unit and user interface. Does not include pulse oximetry and probe extension cord.
Note. The pulse oximeter may consist of hardware that is scattered at multiple locations, for example, where the application part and the primary display part of a telemetry system are not
The same physical location.
3.20
Pulse oximetry pulseoximeterprobe
Is part of the pulse oximeter device, including the application of components and sensor components.
Note 1. Termaneous sensors and transducers are also used in pulse oximetry probes.
Note 2. The pulse oximeter usually contains a cable, as well as a hard or soft component that includes two transmitters and a receiving tube.
3.21
Pulse oximeter probe fault pulseoximeterprobefault
Pulse oximetry or probe cable extension cord abnormal condition, if not detected, will endanger the safety of patients.
Note. Providing an incorrect value, so that the patient's exposure to the probe's high temperature or the risk of introducing current shocks may compromise the safety of the patient.
3.22
Ratio ratio
Modulation ratio
Ratio ratio
Is the basic amount of the pulse oximeter device derived from the measured light intensity over time.
Note. The pulse oximeter device uses an experimentally proven calibration curve and derives SpO2 from the R value. See also FF.4.
3.23 *
Reprocessing
Anything that is not indicated in the random file that allows a used product to be re-used.
Note 1. Such acts usually refer to refurbishment, restoration, reuse, refurbishment, repair or restructuring.
Note 2. Such behavior may occur in medical care institutions.
3.24
Arterial oxygen saturation SaO2
Arterial blood with oxygen - bound function hemoglobin fraction.
Note 1. Refer to the requirements of the acceptable SaO2 measurement method in 50.101.2.2.
Note 2. SaO2 is functional oxygen saturation in arterial blood (see 3.9).
Note 3. usually expressed as a percentage (score multiplied by 100).
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3.25
Pulse Oxygen Saturation
Estimated values for SaO2 by pulse oximeter equipment.
Note 1. Dual-wavelength pulse oximetry equipment in the estimation of SaO2, and can not compensate for the presence of lesions caused by the interference of hemoglobin.
Note 2. usually expressed as a percentage (score multiplied by 100).
3.26
Total hemoglobin concentration totalhaemoglobinconcentration
CtHb
The sum of all concentrations of hemoglobin, including, but not limited to, the concentration of oxyhemoglobin (cO2Hb), methemoglobin
Concentration (cMetHb), deoxyhemoglobin concentration (cHHb), thiomaloglobin concentration (cSuHb) and carboxyhemoglobin concentration (cCOHb).
Note. See also references [16].
4 General requirements and test requirements
In addition to the following, the provisions of Chapter 3 and Chapter 4 of GB 9706.1-2007 apply.
increase.
4.101 other test methods
If the method that can be obtained is equivalent to what is defined in this standard in terms of safety class and performance, the manufacturer may use the same
Standard details of different types of test methods, when there is a dispute, the method declared here should be used as a reference method.
4.102 Acceptable criteria
In terms of performance, many of the test items in this standard establish acceptable criteria. These acceptable criteria should always be met.
When the manufacturer claims that the performance level in the random file is superior to the requirements specified in this standard, the manufacturer's claimed performance
Acceptable criteria.
For example. For a 1% SpO2 accuracy claim, for all requirements, such as in the EMC (Electromagnetic Compatibility) test,
Stroke oxygen meter can achieve 1% SpO2 accuracy.
4.103 pulse oximeter equipment, parts and accessories
Pulse oximetry equipment, and all individual components and accessories that are claimed to be used on the device, as well as the manufacturer's claim to be used for this
All combinations of components or accessories of the pulse oximeter device shall comply with all the requirements specified in this standard.
Note 1. This requirement, combined with the expected pulse oximetry, is intended to ensure that the basic safety of the accessories and components of the pulse oximeter device and the main
To performance.
Note 2. Pulse oximetry monitors are frequently used with some pulse oximetry and extension cord from different manufacturers. This requirement ensures that such groups
Compatibility.
All combinations of claims for the pulse oximeter device, as well as individual components and accessories for all pulse oximetry devices, should be used
Note in the book. See also 6.8.2aa) 11) and 6.8.2aa) 12).
5 classification
Chapter 5 of GB 9706.1-2007 applies.
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6 identification, identification and documentation
In addition to the following, Chapter 5 of GB 9706.1-2007 applies.
6.1 Identification of the external or part of the equipment
replace.
D) the minimum requirements identified on the equipment or replaceable parts
If the pulse oximeter equipment size is not allowed to paste the common standard GB 9706.1 (IEC 60601-1. 1988) and this standard in this
All the identifiers specified in the chapter, the following shall be marked at least.
--- the name of the manufacturer;
- a serial number [or a symbol 3.16] in YY 0466-2003 (ISO 15223..2000), or a type identifier,
Or the batch identifier [or the symbol 3.14 in YY 0466-2003 (ISO 15223..2000); and
--- text "Note, please refer to random file" or ISO 044 in the symbol 0434;
- If a SpO2 alarm is not provided, an impact statement for "no SpO2 alarm" should be provided, or if the symbol in IEC 60417
No. 5319.
replace;
F) Model or type reference
- a serial number (or a symbol 3.16 in YY 0466-2003), or a type identifier, or a batch identifier (or
Reference to symbol 3.14 in ISO 15223..2000);
--- Removable pulse oximetry on its own or outer packaging, should be properly marked on the type of identification code, or batch identification
(Or the symbol 3.14 in YY 0466-2003), or the serial number (or the symbol in YY 0466-2003
3.16).
The reprocessed oxygen probe should also be identified.
Add.
Aa) display the value
The pulse oximeter should display functional oxygen saturation as a percentage of oxygen saturation and should be expressed as% SpO2 or SpO2
To identify. The pulse rate should be displaye......
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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