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Medical electrical equipment. Part 1-8: General requirements for safety. Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
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Medical electrical equipment.Part 1-8. General requirements for safety.Collateral standard. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICS 11.040.01
C30
People's Republic of China Pharmaceutical Industry Standard
YY 00709-2009/IEC 60601-1-8..2003
Instead of ＹＹ574.1 ~ 057.44.3-2005
Medical electrical equipment. Part 1-8.
Safety common requirements juxtaposed standards. general requirements,
Medical electrical equipment and medical electrical systems
Testing and guidelines for alarm systems
(IEC 60601-1-1-8..2003, IDT)
2009-11-11 25 Issued.2010-12-12 01 Implementation
Published by the State Food and Drug Administration
Contents
Foreword I
First article overview 1
1 Scope and purpose 1
2 Terms and definitions 2
6 Identification, marking and documentation 5
Chapters 2 to 10 6
2001 Alarm System 6
Appendix 16
Appendix D (Normative) Symbols for Marking 16
Appendix AAA (Informative) Basic Principles and Guidelines 19
Appendix BBB (Informative) References to symbols, signs and documents 40
Appendix CCC (Informative) Guidelines for audible alarm signals 42
Appendix DDD (informative) Voice alarm signal 43
Appendix EEE (Normative Appendix) Alarm signal predetermined tones 45
References 46
Foreword
All technical content of this collateral standard is mandatory.
The series of safety standards for Medical Electrical Equipment consists of two parts.
--- Part 1. General safety requirements;
--- Part 2. Safety-specific requirements.
Part 1 includes other standards in addition to this juxtaposed standard.
--- GB 976.1 Medical electrical equipment Part 1. General requirements for safety;
--- 0505 Medical electrical equipment-Part 1-2. General requirements for safety and safety standards. EMC requirements and tests;
--- GB 9706.12 Medical electrical equipment. Part 1-3. General requirements for safety. Collateral standard. Diagnostic X-ray equipment radiation.
General protection requirements;
--- GB 9706.15 Medical electrical equipment. Part 1-1. Common safety requirements. Collateral standard. Medical electrical system safety.
Claim.
This collateral standard is Part 1-8 of "Medical Electrical Equipment".
This collateral standard replaces. ＹＹ054.1-2005 "Alarm and Respiratory Care Alarm Signals Part 1. Visual Alarm Signals",
ＹＹ054.2-2005 "Anesthesia and Respiratory Care Alarm Signals Part 2. Audible Alarm Signals", ＹＹ57.3-2005
Respiratory care alarm signals. Part 3. Alarm application guide.
This collateral standard is equivalent to IEC 60601-1-8..2003 "Medical Electrical Equipment Part 1-8. General Requirements for Safety.
Standard. General requirements, testing and guidance for alarm systems in medical electrical equipment and medical electrical systems.
The main differences between this collateral standard and IEC 60601-1-8 are as follows.
--- For other international standards referenced in the standard, if they have been converted into Chinese standards, this parallel standard will replace the referenced international standard number
Is the corresponding national standard number;
--- Deleted the index of term definition;
--- Terms are indicated in bold in the text.
Appendix D and Appendix EEE of this collateral standard are normative appendices, Appendix AAA, Appendix BBB, Appendix CC, and Appendix DDD are information
Material appendix.
This collateral standard is under the jurisdiction of the National Medical Electrical Standardization Technical Committee (SAC/TC10).
This collateral standard was drafted by the Shanghai Medical Device Testing Institute.
The main drafter of this joint standard. He Jun.
Medical electrical equipment. Part 1-8.
Safety common requirements juxtaposed standards. general requirements,
Medical electrical equipment and medical electrical systems
Testing and guidelines for alarm systems
First overview
1 Scope and purpose
1.2001 Application
This collateral standard specifies requirements for alarm systems and alarm signals in medical electrical equipment and medical electrical systems.
It also provides guidance for the application of alarm systems.
1.202 Purpose
The purpose of this collateral standard is to specify the basic safety and basic performance of alarm systems in medical electrical equipment and medical electrical systems
Requirements and test requirements, and provide their application guidelines. This is done by the urgency, consistent alarm signals and consistent
All alarm systems are marked to define the alarm type (priority).
Note. Refer to the description of basic safety and basic performance in IEC 60513..1994 [4].
This collateral standard does not specify.
--- Whether an alarm system is required for specific medical electrical equipment or medical electrical systems;
--- the specific environment that triggered the alarm state;
--- Priority assignment for specific alarm states; or
--- The way to generate an alarm signal.
1.203 Relationship with other standards
1.203.1 GB 970.1
For medical electrical equipment, this collateral standard is a supplement to GB 976.1.
When referring to GB 9706.1 or this juxtaposed standard alone or in combination, the following conventions are used.
--- "General Standard" means GB 97016.1 alone;
--- "This juxtaposed standard" means Z00709 alone;
--- "This standard" refers to the combination of the universal standard and this juxtaposed standard.
1.203.2 Special standards
The requirements in the dedicated standard take precedence over the corresponding requirements in this collateral standard.
1.203.3 Normative references
The clauses in the following documents become the clauses of this document after being referenced. For dated references, all subsequent documents
The amendments (excluding the content of errata) or revisions are not applicable to this document, however, parties who have reached an agreement based on this document are encouraged to study
Is the latest version of these files available? For undated references, the latest edition applies to this document.
GB/T 3767-1996 Acoustic sound pressure method Determination of sound power level of noise source Approximate free field above reflecting surface Engineering method
(Eqv ISO 3744..1994)
GB/T 54625.2 Graphical symbols for electrical equipment (GB/T 546.2-1996, idt IEC 60417..1994)
GB 970.1-2007 Medical electrical equipment Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)
GB 9706.15-2008 Medical electrical equipment. Part 1-11. General requirements for safety. Collateral standard. Safety requirements for medical electrical systems (IEC 60601-1-1..2000, IDT)
GB/T 16273.1-2008 Graphical symbols for equipment. Part 1. Common symbols (ISO 70000..2004, NEQ)
IEC 60601-1-6 Medical electrical equipment Part 1-2. General requirements for safety. Collateral standard. Availability
IEC 60551. 1979 Revision 1..1993, Revision 2..2001 Sound level meter
2 Terms and definitions
The following terms and definitions apply to this standard.
Note. The term “equipment” used in this collateral standard refers to medical electrical equipment or non-medical electrical equipment under medical electrical systems.
2.201
The status of the alarm system when a potential or actual hazard has been identified.
Note 1. The alarm status may be invalid, for example. a false positive alarm status.
Note 2. Alarm status may be missed, for example. a false negative alarm status.
2.202
The time it takes for the alarm system to determine that an alarm condition exists from the occurrence of the trigger event. Among them, the triggering event can be the patient's physiology
The alarm status can also be the technical alarm status of the device.
2.203
Thresholds used by the alarm system to determine alarm status.
2.204
The state of the alarm system or part of the alarm system that does not generate an alarm signal indefinitely.
2.205
The alarm system or part of the alarm system has a state where no alarm signal is generated within a time limit.
2.206
A set of stored configuration parameters that affect or change the performance of the alarm system, including the selection of the algorithm and the initial values used by the algorithm.
2.207
There is no relevant alarm status at present, and the alarm signal stops due to the action of the operator.
2.208
Alarm system configuration, including but not limited to.
--- Alarm limit;
--- the characteristics of the failure status of any alarm signal; and
--- Determine the variable value or parameter value of the alarm system function.
Note. Some alarm settings determined by the algorithm may take time to determine or redefine.
2.209
The type of signal generated by the alarm system to indicate the presence (or occurrence) of any alarm condition.
2.210
Time from the occurrence of an alarm state to the generation of an alarm signal.
2.211
The medical electrical equipment or part of medical electrical system to detect alarm status and generate alarm signal appropriately.
2.212
The state of an alarm system or part of an alarm system that does not produce an audible alarm signal indefinitely.
2.213
The alarm system or part of the alarm system has a state where no audible alarm signal is generated within a time limit.
2.214
A set of pulses with a specific rhythm or pattern.
2.215
The alarm system reduces the priority of the alarm state or reduces the urgency of the alarm signal.
2.216
Alarm presets that can be activated by the alarm system without operator action.
Note. The alarm preset set by the manufacturer or user may be one of the default alarm presets.
2.217
The alarm system involves multiple devices in the medical electrical system.
Note. The components of the distributed alarm system can be spaced far apart.
2.218
The alarm system raises the priority of the alarm condition or enhances the urgency of the alarm signal.
2.219
The time interval from 90% to 10% of the maximum amplitude of the pulse. (See Figure.201)
2.220
When a valid trigger event occurs in a patient, device, or alarm system, no alarm condition occurs.
Note. The alarm status can be rejected or lost due to false information generated by the patient, patient device interface, other devices, or the device itself.
2.221
An alarm condition occurs when a non-valid trigger event occurs in a patient, device, or alarm system.
Note. The false positive alarm status can be caused by false information generated by the patient, the patient device interface, other devices, or the device itself.
2.222
Indication requires immediate operator response.
Note. Priority is determined through risk analysis.
2.223
Any signal that is not a warning or alert signal.
Example 1. ECG waveform.
Example 2. Sound of blood oxygen saturation.
Example 3. Indication of the outgoing beam.
2.224
An alarm system that does not require operator intervention and makes logical judgments based on monitored information.
Example 1. An alarm system that changes priority based on the rate of change of a monitored variable.
Example 2. When an alarm signal is generated in a related high-priority alarm state, the alarm system in the alarm state is suppressed.
2.225
Time interval from the end of the last pulse in the burst of the same alarm signal to the start of the first pulse in the next burst.
(See Figure.201)
2.226
An alarm signal that continues to be generated after the trigger event no longer exists and stops until the operator intentionally moves.
2.227
The instructions require the operator's attention.
Note. Priority is determined through risk analysis.
2.228
Indication requires immediate operator response.
Note. Priority is determined through risk analysis.
2.229
When the associated trigger event no longer exists, the alarm signal generated automatically stops.
2.230
The expected position of the operator relative to the alarm signal generating part of the alarm system.
Note. Distributed alarm systems may have multiple operator positions.
2.231
Alarm status generated by monitoring patient-related variables.
Example 1. High exhaled anesthetic concentration.
Example 2. Low exhaled tidal volume.
Example 3. Hypoxemia measured by a pulse meter.
Example 4. High arterial pressure.
Example 5. High heart rate.
2.232
A short continuous tone with special spectral content.
2.233
The fundamental frequency (first harmonic) of a pulse.
2.234
Periodic signal that the alarm system reminds the operator when the alarm signal is inactive.
2.235
The time interval from the maximum amplitude of the pulse to 10% to 90%. (See Figure.201)
2.236
Technical alarm status
Alarm status generated by monitoring equipment-related or alarm system-related variables.
Example 1. Electrical, mechanical or other malfunction.
Example 2. Sensor or component failure (unsafe voltage, high impedance, signal impedance, artificial tissue, noise signal, disconnection, calibration error, blocked pipe, etc.).
Example 3. Algorithms that cannot classify or process available data.
6 Identification, marking and documentation
6.3 Controller and instrument marking
Note. This collateral standard specifies the additional requirements for the marking of controllers and meters. Together with the technical requirements, the marking requirements have been increased. These requirements are described in BBB. 1
Listed.
6.7 Indicators and buttons
a) Indicator color
After the first sentence, add.
See.2011.3.2.2.2.
After the second sentence, add.
See.2011.3.2.2.2.
6.8.1 Random files
Note. This collateral standard specifies additional requirements for random documents. Together with technical requirements, the requirements for random documents are increased. These requirements are shown in Table BBB. Listed in 2.
6.8.2 Instruction Manual
supplement.
aa) alarm system
The instruction manual should.
--- Provide an overview of the alarm system, including a list and description of each possible alarm state, and a summary of how the alarm state is determined for the intended operator when applicable;
--- indicate any inherent delay in determining alarm status;
--- state the position of the operator; and
--- Including how and when to verify that the alarm system is working.
If applicable, the instruction manual should.
--- Warning Do not set an alarm limit that exceeds the limit, as this will cause the alarm system to fail.
Note. This collateral standard specifies the additional requirements of the instruction manual. Together with the technical requirements, it improves the requirements of the instruction manual. These requirements are shown in Table BBB. Listed in 3.
6.8.3 Technical specifications
supplement.
Note. This collateral standard specifies the additional requirements of the technical description. Together with the technical requirements, it improves the requirements of the technical description. See the table for these requirements
BBB. Listed in 4.
Second to tenth
Not adopted.
supplement.
2001 Alarm System
201.1 Alarm status
2011.1.1 Overview
If the alarm status is classified by the manufacturer into a physiological alarm status, a technical alarm status, or another alarm status, it shall be described in the instruction manual.
Compliance is checked by inspection of the instruction manual.
2011.1.2. Priority of alarm status
The alarm status should be assigned one or more of the following priorities. high priority, medium priority, low priority. Except in specific standards
A special alarm status is specified in the priority. The priority allocation is part of the risk management control and should be based on Table.201.
The priority of each alarm state should be stated in the instructions. Priorities can be defined in groups.
Note. ＹＹ/T 0316 pointed out the risk management control of medical devices.
Compliance is checked by inspection of instruction manuals and risk management documents.
Table.201 Priority of alarm status
Caused by alarm status failure
Potential result
Start potential harma
Immediate b immediate c delayed d
Death or irreversible damage High priority e High priority Medium priority
Reversible damage High priority Medium priority Low priority
Minor injury or discomfort Medium priority Low priority Low priority or no alarm signal
An information signal can also be used to indicate potential lag for minor injuries or discomfort.
a Initial potential hazard is when the hazard has not been proven, but has already occurred.
b Potential events develop over a period of time, usually during which manual corrective actions are insufficient to implement.
c Potential events develop over a period of time, usually during which manual corrective actions are sufficient.
d The development of a potential event requires a non-specific period, which is longer than the "immediate" period.
e Medical electrical equipment with a therapeutic function is usually designed to prevent death or irreversible injuries with automatic safety mechanisms.
201.2 Explanation of Intelligent Alarm System
If an intelligent alarm system is provided, if applicable, the instruction manual shall outline how the alarm system.
a) Determine alarm status based on time, weighting, multivariate, or other advanced processing (including but not limited to algorithms, neural networks, fuzzy logic, etc.);
b) For the generation of two or more alarm signals with the same priority alarm status (including but not limited to the internal sequence and the impact on the generation of alarm signals);
c) change the order of pre-assigned priorities or relative priorities (eg upgrade or downgrade) for specific alarm states;
d) delay in changing the alarm signal generation or alarm status; and
e) Change the characteristics of the generated alarm signal (for example. volume, slope, speed, urgency).
Compliance is checked by checking the instruction manual.
201.3 generation of alarm signals
2011.3.1 Overview
Each alarm condition specified in this collateral standard shall cause the generation of a visual alarm signal. If intended use of the alarm system
An additional warning signal shall be generated as deemed necessary after the environmental risk assessment. These additional alarm signals can be audible, audible,
Vibrating or otherwise generated.
For example, an alarm system with a high or medium priority alarm state that does not always attract the operator's attention during normal use should generate additional audible alarm signals.
Compliance is checked by inspection of the alarm system.
2011.3.2 Visual alarm signal
2011.3.1.2.1 Overview
The alarm system should generate visual alarm signals to indicate the existence, priority and specific status of each alarm condition.
2011.3.2.2.2 Characteristics of visual alarm signals
If the operator needs to use visual instructions to identify equipment or equipment parts that require operator response or attention, at least one visual alarm signal should be provided.
a) the priority indicating the highest priority alarm status; and
b) can be accurately detected at a distance of 4 m from the alarm system.
If the image of the alarm indicator or analog indicator is used for the above purpose, it shall meet the requirements of color and flicker in Table 202. As
Alternatively, such an indication may be generated by other types of visual displays or devices.
For alarm systems that do not contain high- or medium-priority alarm states, if their visual
If the middle-priority alarm indicators do not confuse each other, this requirement is waived.
Note 1. Visual indication is required for alarm systems intended to be located around other alarm systems.
Note 2. The wearing of the alarm system does not require visual indication, for example. call receiver.
Note 3. The indicator light can be simulated, for example, by graphic display.
Table 202 Characteristics of the alarm indicator
Alarm Type Indicator Color Flashing Frequency Duty Cycle
High priority red 1.4Hz ～ 2.8Hz 20% ～ 60%
Medium priority yellow 0.4Hz to 0.8Hz 20% to 60%
Low priority cyan or yellow normally open 100%
In order to determine the special alarm status and its priority, at least one visual alarm signal should be provided. This signal is in the distance device or part
The equipment or 1m away from the operator should be accurately (clearly) noticed. This visual indication can be placed next to the indicator light or displayed
Text on the monitor. Existing alarm states can be indicated (marked) by the symbols in GB/T 54625.2 (see symbol 1 in Table D.201).
Priority can be indicated by adding one, two, or three additional symbols (for example.! Represents low priority, !!! represents medium priority, !!! represents high priority).
Note 4. Factors affecting the legibility of visual signals include the characteristics and characteristics of visual signals themselves, the brightness of light around the use environment, and the angle of view and distance.
Note 5. Blinking text is not recommended because blinking text is usually not easy to read. Blinking text is in normal and opposite images or other colors.
Inter-transformation is acceptable.
Note 6. The multi-purpose computer-generated image display should be based on the design principles of modern human-machine interface, refer to IEC 60601-1-6.
Note 7. The alarm status is defined to convey necessary information for patient safety and safe use of equipment.
If multiple alarm signals occur at the same time, unless the intelligent alarm system provides the
Signal (see.201.2) to prevent the alarm signal from being generated in the lower internal alarm state, otherwise each independent alarm state is automatically or through the operator
Actions should be visually indicated.
If a visual information signal is provided, it should be correctly detected and distinguished from the visual alarm signal at a distance of 1 m from the alarm system or the operator's position.
Check the visual alarm signal using the following conditions.
--- According to the log MAR [17] scale, the visual acuity of the operator is 0, or the visual acuity is 6-6 (20/20) (correction if necessary)
vision);
--- The observation point is at the position of the operator or in the vertical direction or horizontal plane with the center of the display plane of the monitor or visual indicator
Any position in a cone with an angle of 30 °; and
--- The surrounding illumination is between 100lx and 1500lx [21].
2011.3.3 Audible alarm signal
2011.3.1.3.1 Characteristics of auditory alarm signals
An alarm system with an audible alarm signal should have at least one set of alarm signals that meet the following conditions.
a) encode the priorities and meet the requirements of Tables 203 and 204; or
b) Generated using different technical methods (for example, speech alarm signals for speech synthesis) and verified (for example, clinical or analog
Clinical usability test).
Table 203. Characteristics of bursts of audible alarm signals
Characteristic High priority alarm signal Medium priority alarm signal Low priority alarm signal d
Pulse number a, e 10 3 1 or 2 in the pulse group
Between the first and second pulses
Between the second and third pulses
Between the third and fourth pulses
Between the 4th and 5th pulses
Between the 5th and 6th pulses
Between the sixth and seventh pulses
Between the seventh and eighth pulses
Between the 8th and 9th pulses
Between the 9th and 10th pulses
狓 y y
狓 狔 Not applicable
狓 Not applicable Not applicable
0.35s to 1.30s Not applicable Not applicable
狓 Not applicable Not applicable
狓 Not applicable Not applicable
狓 Not applicable Not applicable
The difference in amplitude between any two pulses is 10 dB max. 10 dB max. 10 dB max.
The threshold value is between 50 ms and 125 ms.
The threshold value is between 125 ms and 250 ms.
The range of radon and radon in a burst should be ± 5%.
a See the characteristics of the pulses in Table 204.
b Unless specified in special standards for special medical electrical equipment.
c Encourage manufacturers to use the longest burst interval consistent with the risk analysis. In order to facilitate the application of special alarm systems, the development of special standards is encouraged
One considers the longest and most suitable burst interval for an audible alarm signal. In terms of time, the long burst interval can correctly identify under certain conditions.
The alarm status signal source has a negative effect.
d. The generation of an audible signal in a low priority alarm state is optional.
e Unless the operator's prevention, the medium and low priority audible alarm signals should complete at least one burst, the high priority audible alarm signal
No. should complete at least half a burst.
Table 204 Characteristics of auditory alert signal pulses
Eigenvalues
The number of harmonic components between 300Hz and 4,000Hz is at least 4
high priority
Medium and low priority
75ms to.200ms
125ms ～ 250ms
Note. The relative sound pressure level of the harmonic components should be within ± 15 dB of the amplitude at the pulse frequency.
a Do not overlap pulses.
Note. Figure.2001 only shows the time characteristics and does not represent any independent audible alarm signal.
Figure.201 Time characteristics of the audible alarm signal
If the alarm system additionally provides additional audible alarm signal settings, the following requirements shall apply.
c) the audible alarm signal should be coded with priority;
d) For a specific set of high-priority audible alarm signals, it should be better than the middle- or low-priority alarm signals and information signals.
Reach a high degree of urgency;
e) For a specific set of intermediate priority audible alarm signals, the urgency expressed by lower priority alarm signals and information signals
To be high
f) that the audible alarm signal should be verified, for example, by a clinical or simulated clinical usability test;
g) methods should be provided for storing a set of audible alarm signals in the default alarm presets; and
h) A method can be provided for storing a set of audible alarm signals into any alarm preset.
Note 1. See Appendix CCC.
Note 2. Note the IEC 60601-1-6.
Any tones should exclude the possibility of confusion with the audible alarm signals in Tables.2003,.2004 and Appendix EEE, unless they
The same meaning. If the use of any tone in the Appendix EEE is to meet the requirements in Tables 203 and 204, the meaning should be in the Appendix
It is stipulated in EEE.
Technical alarm conditions that prevent conventional alarm signals, such as. power or alarm system failure, hearing generated by the alarm system
The alarm signal may not meet the above requirements.
If a choice of audible alarm signal settings is provided, measures should be provided to the user to pr......
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Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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