cal 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
1 Scope and object
1.201 Scope
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 Object
The object of this collateral standard is to specify basic safety and essential performance requirements and tests for alarm systems in medical electrical equipment and medical electrical 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.
Note: See IEC 60513:1994 [4] for a description of basic safety and essential performance.
This collateral standard does not specify:
——whether any particular medical electrical equipment or medical electrical 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.
1.203 Relationship to other standards
1.203.1 GB 9706.1
For medical electrical equipment, 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;
——“this collateral standard" designates YY 0709 alone;
——“this standard" designates the combination of the general standard and this collateral standard.
1.203.2 Particular standards
A requirement in a particular standard takes priority over the corresponding requirement in this collateral standard.
1.203.3 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, subsequent amendments (excluding corrections), or revisions, of any of these publications do not apply to this document, however parties to agreements based on this document are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
GB/T 3767-1996 Acoustics - Determination of sound power levels of noise sources using sound pressure - Engineering method in an essentially free field over a reflecting plane (eqv ISO 3744: 1994)
GB/T 5465.2 Graphical symbols for use on electrical equipment (GB/T 5465.2-1996, idt IEC 60417: 1994)
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 - Collateral standard: Safety requirements for medical electrical systems (IEC 60601-1-1: 2000, IDT)
GB/T 16273.1-2008 Graphical symbols for use on equipment - Part 1: Common symbols (IEC 7000: 2004, NEQ)
IEC 60601-1-6 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Usability
IEC 60651:1979 Sound level meters Amendment 1 (1993) Amendment 2 (2000)
2 Terms and definitions
For the purposes of this standard, the following terms and definitions apply.
Note: This collateral standard uses the term "equipment” to mean medical electrical equipment or non-medical electrical equipment in the context of a medical electrical system.
2.201*
alarm condition
state of the alarm system when it has determined that a potential or actual hazard exists
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.
2.202*
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
2.203*
alarm limit
threshold used by an alarm system to determine an alarm condition
2.204
alarm off
state of indefinite duration in which an alarm system or part of an alarm system does not generate alarm signals
2.205*
alarm paused
state of limited duration in which the alarm system or part of the alarm system does not generate alarm signals
2.206
Foreword i
Section one - General
1 Scope and object
2 Terms and definitions
6 Identification, marking and documents
Section two to ten
201 Alarm system
Annexes
Annex D (Normative) Symbols on marking
Annex AAA (informative) Rationale and guidance
Annex BBB (informative) Cross-reference of identification, marking, and documents
Annex CCC (informative) Guidance for auditory alarm signals
Annex DDD (informative) Verbal alarm signals
Annex EEE (Normative) Reserved melodies for alarm signals*
Bibliography
