YY 9706.108-2021 Medical electrical equipment—Part 1-8:General requirements for basic safety and essential performance-Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (English Version)
Medical electrical equipment—Part 1-8:General requirements for basic safety and essential performance-Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
1 * Scope, object and related standards
1.1 Scope
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in ME EQUIPMENT and ME SYSTEMS.
It also provides guidance for the application of ALARM SYSTEMS.
Note: This part of the chapter and article with an asterisk (*) in Appendix A has the relevant principle description.
1.2 Object
The object of this collateral standard is to specify BASIC SAFETY and ESSENTIAL PERFORMANCE requirements and tests for ALARM SYSTEMS in ME EQUIPMENT and ME SYSTEMS and to provide guidance for their application. This is accomplished by defining alarm categories (priorities) by degree of urgency, consistent ALARM SIGNALS and consistent control states and their marking for all ALARM SYSTEMS.
This collateral standard does not specify:
——whether any particular ME EQUIPMENT or ME SYSTEM is required to be provided with ALARM SYSTEMS;
——the particular circumstances which initiate an ALARM CONDITION;
——the allocation of priorities to a particular ALARM CONDITION; or
——the means of generating ALARM SIGNALS.
1.3 Related standards
1.3.1 GB 9706.1
For ME EQUIPMENT and ME SYSTEMS, this collateral standard complements GB 9706.1.
When referring to GB 9706.1 or to this collateral standard, either individually or in combination, the following conventions are used:
——"the general standard" designates GB 9706.1 alone (latest edition including any amendments);
——"this collateral standard" designates YY 0709 alone;
——"this standard" designates the combination of the general standard and this collateral
standard.
1.3.2 Particular standards
A requirement in a particular standard takes priority over the corresponding requirement in this collateral standard.
2 Normative references
The following referenced documents, in whole or in part, are normatively referenced in this document and are indispensable for the its application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 3767-2016 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Engineering methods for an essentially free field over a reflecting plane (ISO 3744:2010, IDT)
GB/T 3785.1-2010 Electroacoustics - Sound level meters - Part 1:Specifications (IEC 61672-1:2002, IDT)
GB 9706.1-2020 Medical electrical equipment - Part 1:General requirements for basic safety and essential performance (IEC 60601-1:2012, MOD)
YY/T 1474 Medical devices - Application of usability engineering to medical devices (YY/T 1474-2016, IEC 62366:2007, IDT)
ISO 7000 Graphical symbols for use on equipment
IEC 60417 Graphical symbols for use on equipment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB 9706.1-2020 and YY/T 1474, and the following definitions apply.
Note 1: The term “electrical equipment” is used to mean ME EQUIPMENT or other electrical equipment. This standard also uses the term “equipment” to mean ME EQUIPMENT or other electrical or non-electrical equipment in the context of an ME SYSTEM.
3.1
* alarm condition
state of the ALARM SYSTEM when it has determined that a potential or actual HAZARD HAZARDOUS SITUATION exists for which OPERATOR awareness or response is required
Note 1: An ALARM CONDITION can be invalid, i.e. a FALSE POSITIVE ALARM CONDITION.
Note 2: An ALARM CONDITION can be missed, i.e. a FALSE NEGATIVE ALARM CONDITION.
3.2
* alarm condition delay
time from the occurrence of a triggering event either in the PATIENT, for PHYSIOLOGICAL ALARM CONDITIONS, or in the equipment, for TECHNICAL ALARM CONDITIONS, to when the ALARM SYSTEM determines that an ALARM CONDITION exists
3.3
* alarm limit
threshold used by an ALARM SYSTEM to determine an ALARM CONDITION
3.4
alarm off
state of indefinite duration in which an ALARM SYSTEM or part of an ALARM SYSTEM does not generate ALARM SIGNALS
3.5
* alarm paused
state of limited duration in which the ALARM SYSTEM or part of the ALARM SYSTEM does not generate ALARM SIGNALS
3.6
alarm preset
set of stored configuration parameters, including selection of algorithms and initial values for use by algorithms, which affect or modify the performance of the ALARM SYSTEM
3.7
alarm reset
OPERATOR action that causes the cessation of an ALARM SIGNAL for which no associated ALARM CONDITION currently exists
3.8
alarm settings
ALARM SYSTEM configuration, including but not limited to:
–ALARM LIMITS;
–the characteristics of any ALARM SIGNAL inactivation states; and
–the values of variables or parameters that determine the function of the ALARM SYSTEM
Note: Some algorithmically-determined ALARM SETTINGS can require time to be determined or re-determined.
3.9
alarm signal
type of signal generated by the ALARM SYSTEM to indicate the presence (or occurrence) of an ALARM CONDITION
3.10
* alarm signal generation delay
time from the onset of an ALARM CONDITION to the generation of its ALARM SIGNAL (S)
3.11
alarm system
parts of ME EQUIPMENT or a ME SYSTEM that detect ALARM CONDITIONS and, as appropriate, generate ALARM SIGNALS
3.12
audio off
state of indefinite duration in which the ALARM SYSTEM or part of the ALARM SYSTEM does not generate an auditory ALARM SIGNAL
3.13
audio paused
state of limited duration in which the ALARM SYSTEM or part of the ALARM SYSTEM does not generate an auditory ALARM SIGNAL
3.14
burst
group of PULSES with a distinctive rhythm or pattern
3.15
de-escalation
process by which an ALARM SYSTEM decreases the priority of an ALARM CONDITION or decreases the sense of urgency of an ALARM SIGNAL
3.16
default alarm preset
ALARM PRESET that can be activated by the ALARM SYSTEM without OPERATOR action
Note: MANUFACTURER or RESPONSIBLE ORGANIZATION-configured ALARM PRESETS are possible types of DEFAULT ALARM PRESETS.
3.17
* distributed alarm system
ALARM SYSTEM that involves more than one item of equipment of a ME SYSTEM
Note: The parts of a DISTRIBUTED ALARM SYSTEM can be widely separated in distance.
3.18
escalation
process by which an ALARM SYSTEM increases the priority of an ALARM CONDITION or increases the sense of urgency of an ALARM SIGNAL
3.19
fall time
tf
interval over which the PULSE amplitude decreases from 90 % to 10 % of its maximum (see Figure 1)
3.20
false negative alarm condition
absence of an ALARM CONDITION when a valid triggering event has occurred in the PATIENT, the equipment or the ALARM SYSTEM
Note: An ALARM CONDITION can be rejected or missed because of spurious information produced by the PATIENT, the PATIENT -equipment interface, other equipment or the equipment itself.
3.21
false positive alarm condition
presence of an ALARM CONDITION when no valid triggering event has occurred in the PATIENT, the equipment or the ALARM SYSTEM
Note: A FALSE POSITIVE ALARM CONDITION can be caused by spurious information PATIENT-equipment interface, other equipment or the ALARM SYSTEM itself.
YY 9706.108-2021 Medical electrical equipment—Part 1-8:General requirements for basic safety and essential performance-Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (English Version)
Standard No.
YY 9706.108-2021
Status
valid
Language
English
File Format
PDF
Word Count
30000 words
Price(USD)
900.0
Implemented on
2023-5-1
Delivery
via email in 1~5 business day
Detail of YY 9706.108-2021
Standard No.
YY 9706.108-2021
English Name
Medical electrical equipment—Part 1-8:General requirements for basic safety and essential performance-Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
1 * Scope, object and related standards
1.1 Scope
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in ME EQUIPMENT and ME SYSTEMS.
It also provides guidance for the application of ALARM SYSTEMS.
Note: This part of the chapter and article with an asterisk (*) in Appendix A has the relevant principle description.
1.2 Object
The object of this collateral standard is to specify BASIC SAFETY and ESSENTIAL PERFORMANCE requirements and tests for ALARM SYSTEMS in ME EQUIPMENT and ME SYSTEMS and to provide guidance for their application. This is accomplished by defining alarm categories (priorities) by degree of urgency, consistent ALARM SIGNALS and consistent control states and their marking for all ALARM SYSTEMS.
This collateral standard does not specify:
——whether any particular ME EQUIPMENT or ME SYSTEM is required to be provided with ALARM SYSTEMS;
——the particular circumstances which initiate an ALARM CONDITION;
——the allocation of priorities to a particular ALARM CONDITION; or
——the means of generating ALARM SIGNALS.
1.3 Related standards
1.3.1 GB 9706.1
For ME EQUIPMENT and ME SYSTEMS, this collateral standard complements GB 9706.1.
When referring to GB 9706.1 or to this collateral standard, either individually or in combination, the following conventions are used:
——"the general standard" designates GB 9706.1 alone (latest edition including any amendments);
——"this collateral standard" designates YY 0709 alone;
——"this standard" designates the combination of the general standard and this collateral
standard.
1.3.2 Particular standards
A requirement in a particular standard takes priority over the corresponding requirement in this collateral standard.
2 Normative references
The following referenced documents, in whole or in part, are normatively referenced in this document and are indispensable for the its application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 3767-2016 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Engineering methods for an essentially free field over a reflecting plane (ISO 3744:2010, IDT)
GB/T 3785.1-2010 Electroacoustics - Sound level meters - Part 1:Specifications (IEC 61672-1:2002, IDT)
GB 9706.1-2020 Medical electrical equipment - Part 1:General requirements for basic safety and essential performance (IEC 60601-1:2012, MOD)
YY/T 1474 Medical devices - Application of usability engineering to medical devices (YY/T 1474-2016, IEC 62366:2007, IDT)
ISO 7000 Graphical symbols for use on equipment
IEC 60417 Graphical symbols for use on equipment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB 9706.1-2020 and YY/T 1474, and the following definitions apply.
Note 1: The term “electrical equipment” is used to mean ME EQUIPMENT or other electrical equipment. This standard also uses the term “equipment” to mean ME EQUIPMENT or other electrical or non-electrical equipment in the context of an ME SYSTEM.
3.1
* alarm condition
state of the ALARM SYSTEM when it has determined that a potential or actual HAZARD HAZARDOUS SITUATION exists for which OPERATOR awareness or response is required
Note 1: An ALARM CONDITION can be invalid, i.e. a FALSE POSITIVE ALARM CONDITION.
Note 2: An ALARM CONDITION can be missed, i.e. a FALSE NEGATIVE ALARM CONDITION.
3.2
* alarm condition delay
time from the occurrence of a triggering event either in the PATIENT, for PHYSIOLOGICAL ALARM CONDITIONS, or in the equipment, for TECHNICAL ALARM CONDITIONS, to when the ALARM SYSTEM determines that an ALARM CONDITION exists
3.3
* alarm limit
threshold used by an ALARM SYSTEM to determine an ALARM CONDITION
3.4
alarm off
state of indefinite duration in which an ALARM SYSTEM or part of an ALARM SYSTEM does not generate ALARM SIGNALS
3.5
* alarm paused
state of limited duration in which the ALARM SYSTEM or part of the ALARM SYSTEM does not generate ALARM SIGNALS
3.6
alarm preset
set of stored configuration parameters, including selection of algorithms and initial values for use by algorithms, which affect or modify the performance of the ALARM SYSTEM
3.7
alarm reset
OPERATOR action that causes the cessation of an ALARM SIGNAL for which no associated ALARM CONDITION currently exists
3.8
alarm settings
ALARM SYSTEM configuration, including but not limited to:
–ALARM LIMITS;
–the characteristics of any ALARM SIGNAL inactivation states; and
–the values of variables or parameters that determine the function of the ALARM SYSTEM
Note: Some algorithmically-determined ALARM SETTINGS can require time to be determined or re-determined.
3.9
alarm signal
type of signal generated by the ALARM SYSTEM to indicate the presence (or occurrence) of an ALARM CONDITION
3.10
* alarm signal generation delay
time from the onset of an ALARM CONDITION to the generation of its ALARM SIGNAL (S)
3.11
alarm system
parts of ME EQUIPMENT or a ME SYSTEM that detect ALARM CONDITIONS and, as appropriate, generate ALARM SIGNALS
3.12
audio off
state of indefinite duration in which the ALARM SYSTEM or part of the ALARM SYSTEM does not generate an auditory ALARM SIGNAL
3.13
audio paused
state of limited duration in which the ALARM SYSTEM or part of the ALARM SYSTEM does not generate an auditory ALARM SIGNAL
3.14
burst
group of PULSES with a distinctive rhythm or pattern
3.15
de-escalation
process by which an ALARM SYSTEM decreases the priority of an ALARM CONDITION or decreases the sense of urgency of an ALARM SIGNAL
3.16
default alarm preset
ALARM PRESET that can be activated by the ALARM SYSTEM without OPERATOR action
Note: MANUFACTURER or RESPONSIBLE ORGANIZATION-configured ALARM PRESETS are possible types of DEFAULT ALARM PRESETS.
3.17
* distributed alarm system
ALARM SYSTEM that involves more than one item of equipment of a ME SYSTEM
Note: The parts of a DISTRIBUTED ALARM SYSTEM can be widely separated in distance.
3.18
escalation
process by which an ALARM SYSTEM increases the priority of an ALARM CONDITION or increases the sense of urgency of an ALARM SIGNAL
3.19
fall time
tf
interval over which the PULSE amplitude decreases from 90 % to 10 % of its maximum (see Figure 1)
3.20
false negative alarm condition
absence of an ALARM CONDITION when a valid triggering event has occurred in the PATIENT, the equipment or the ALARM SYSTEM
Note: An ALARM CONDITION can be rejected or missed because of spurious information produced by the PATIENT, the PATIENT -equipment interface, other equipment or the equipment itself.
3.21
false positive alarm condition
presence of an ALARM CONDITION when no valid triggering event has occurred in the PATIENT, the equipment or the ALARM SYSTEM
Note: A FALSE POSITIVE ALARM CONDITION can be caused by spurious information PATIENT-equipment interface, other equipment or the ALARM SYSTEM itself.
