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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 c...