YY 0709-2009 English PDF

Delivery: 2 working-hours manually (Sales@ChineseStandard.net)
Need delivered in 3-second? USA-Site: YY 0709-2009
Get Quotation: Click YY 0709-2009 (Self-service in 1-minute)
Historical versions (Master-website): YY 0709-2009
Preview True-PDF (Reload/Scroll-down if blank)

YY 0709-2009: 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
YY 0709-2009
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 inte...