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YY 9706.108-2021 English PDF (YY9706.108-2021)

YY 9706.108-2021 English PDF (YY9706.108-2021)

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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

YY 9706.108-2021
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.01
C 30
Replacing YY 0709-2009
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
(IEC 60601-1-8:2006+A1:2012, MOD)
ISSUED ON: MARCH 09, 2021
IMPLEMENTED ON: MAY 01, 2023
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope, Object and Related Standards ... 5
2 Normative References ... 6
3 Terms and Definitions ... 7
4 General Requirements ... 12
5 ME EQUIPMENT Identification, Marking and Documents ... 12
6 ALARM SYSTEMS ... 13
Annex A (Informative) General Guidance and Rationale ... 37
Annex B (Informative) Guide to Marking and Labelling Requirements for ME EQUIPMENT and ME SYSTEMS ... 87
Annex C (Normative) Symbols on Marking ... 90
Annex D (Informative) Guidance for Auditory ALARM SIGNALS ... 96
Annex E (Informative) Verbal ALARM SIGNALS ... 98
Annex F (Normative) Reserved Melodies for ALARM SIGNALS ... 101
Bibliography ... 102
Foreword
All technical contents (requirements) of this Part are mandatory.
The serial standards of Medical Electrical Equipment can be divided into two parts: --- Part 1: General and Collateral Requirements;
--- Part 2: Particular Requirements.
This Part is Part 1-8.
This Part was drafted as per the rules specified in GB/T 1.1-2009.
This Part replaced 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. Compared with YY 0709-2009, the major technical changes of this Part are as follows besides the editorial modifications:
--- Update the structure of this Part according to the standard structure of IEC 60601- 1:2005+A1:2012;
--- Add the term "acknowledged" (see 3.37 of this Edition);
--- Add the general requirements (see Clause 4 of this Edition);
--- Added ME equipment identification, marking and documents (see Clause 5 of this Edition);
--- Add the operator adjustable sound pressure level (see 6.3.3.3 of this Edition); --- Add the DISTRIBUTED ALARM SYSTEM intended for confirmed delivery of ALARM CONDITIONS (see 6.11.2.2.1 of this Edition);
--- Add the DISTRIBUTED ALARM SYSTEM not intended for confirmed delivery of ALARM CONDITIONS (see 6.11.2.2.2 of this Edition);
--- Add the technical requirements for the provision of ME equipment with a global AUDIO OFF in a DISTRIBUTED ALARM SYSTEM (see 6.11.2.2.3 of this Edition);
--- Modify the inspection and functional testing methods of the alarm system (see 6.3.3.1 and 6.3.3.2 of this Edition; 201.3.3.1 and 201.3.3.2 of 2009 Edition).
This Part adopts the redrafting method to modify and use IEC 60601-1-8:2006+A1:2012 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). Compared with IEC 60601-1-8:2006+A1:2012, the major technical differences and editorial modifications of this Part are as follows:
--- Regarding the normative references, this Part has made adjustments with technical differences to adapt to the technical conditions of China. The adjustments are reflected in Clause 2 “Normative References”. The specific adjustments are as follows:  Use GB/T 3767-2016 that equivalently adopts international standard to replace ISO 3744:2010;
 Use GB/T 3785.1-2010 that equivalently adopts international standard to replace IEC 61672-1:2002;
 Use GB 9706.1-2020 that modifies and adopts international standard to replace IEC 60601-1:2005+AMD1:2012;
 Use YY/T 1474 that modifies and adopts international standard to replace IEC 62366:2007.
This Part made the following editorial modifications:
--- Add A.3 in Annex A, which gives the corresponding relationship between international standard and current national or industry standard;
--- Delete the index.
Please note some contents of this Document may involve patents. The issuing agency of this Document shall not assume the responsibility to identify these patents. This Part was proposed by National Medical Products Administration.
This Part shall be under the jurisdiction of National Technical Committee on Medical Electrical Equipment of Standardization Administration of China (SAC/TC 10).
Drafting organizations of this Part: Shanghai Testing and Inspection Institute for Medical Devices; and BMC Medical Co., Ltd.
Chief drafting staffs of this Part: He Jun, Chen Xingwen, Chen Bei, Zeng Kejun, Li Zejin, and Ye Shasha.
The historical edition replaced by this Part is as follows:
--- YY 0709-2009.
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 Part 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 Part specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in ME EQUIPMENT and ME SYSTEMS.
This Part also provides guidance for the application of ALARM SYSTEMS.
NOTE: Clauses and subclauses marked with an asterisk (*) in this Part have relevant principle explanations in Annex A.
1.2 Object
The object of this Part 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 Part 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 auditory ALARM SIGNAL sound pressure level is below a threshold that is configured:
– by a means restricted to the RESPONSIBLE ORGANIZATION (see 6.7); or
– by the MANUFACTURER.
This condition may be visually indicated (marked) with symbol IEC 60417-5576 (2002-11) (see Symbol 5 of Table C.1). If this symbol is used as that visual indication, an INFORMATION SIGNAL or other additional visual indication may be provided to distinguish this state from AUDIO OFF.
An ALARM SYSTEM may be equipped with a dynamically algorithm-adjusted minimum auditory ALARM SIGNAL sound pressure level. If equipped, the ALARM SYSTEM shall include a means, accessible only to the RESPONSIBLE ORGANIZATION (see 6.7) to enable and disable the algorithm-adjusted minimum auditory ALARM SIGNAL sound pressure level. If equipped, the instructions for use shall describe the algorithm and the minimum and maximum levels.
EXAMPLE 1: An algorithm that sets the minimum auditory ALARM SIGNAL sound pressure level in response to current ambient sound pressure levels, time of day, evidence of OPERATOR attendance or other variables.
EXAMPLE 2: An algorithm that escalates unresolved active auditory ALARM SIGNALS by increasing their sound pressure level over time.
Compliance is checked by inspection.
6.3.4 * Characteristics of verbal ALARM SIGNALS
When applicable, the MANUFACTURER shall address in the RISK MANAGEMENT
PROCESS the RISKS associated with verbal ALARM SIGNALS.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
6.4 * Disclosure of delays
6.4.1 * ALARM SYSTEM delays
If the sum of the maximum ALARM CONDITION DELAY plus the maximum ALARM
SIGNAL GENERATION DELAY is greater than 10 s, then the statistics of each distribution or statistics of the distribution of the sum shall be disclosed in the instructions for use. If the sum of the mean ALARM CONDITION DELAY plus the mean ALARM SIGNAL GENERATION DELAY is greater than 5 s, then each delay or their sum shall be disclosed in the instructions for use.

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