YY 9706.112-2021 English PDF (YY9706.112-2021)

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YY 9706.112-2021: Medical electrical equipment -- Part 1-12: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical servi
YY 9706.112-2021
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040
C 30
Medical Electrical Equipment – Part 1-12: General
Requirements for Basic Safety and Essential Performance –
Collateral Standard: Requirements for Medical Electrical
Equipment and Medical Electrical Systems Intended
for Use in the Emergency Medical Services Environment
(IEC 60601-1-12:2014, MOD)
ISSUED ON: MARCH 09, 2021
IMPLEMENTED ON: MAY 01, 2022
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 ... 8
4 General Requirements ... 9
5 * Classification of ME EQUIPMENT and ME SYSTEMS ... 15
6 ME EQUIPMENT Identification, Marking and Documents ... 15
7 * Protection against Electrical HAZARDS from ME EQUIPMENT ... 19
8 Protection against Excessive Temperatures and Other HAZARDS ... 19
9 * Accuracy of Controls and Instruments and Protection against Hazardous Outputs
... 22
10 Construction of ME EQUIPMENT ... 23
11 Additional Requirements for Electromagnetic Compatibility of ME EQUIPMENT
and ME SYSTEMS ... 28
Annex A (Informative) General Guidance and Rationale ... 29
Annex B (Informative) Guide to Marking and Labelling Requirements for ME
EQUIPMENT and ME SYSTEMS ... 51
Annex C (Informative) Symbols on Marking ... 54
Bibliography ... 56
Foreword
All the technical contents in this Part are mandatory.
The serial standards of Medical Electrical Equipment are divided into the following parts:
--- Part 1: General and Collateral Requirements;
--- Part 2: Particular Requirements.
This Part is Part 1-12.
This Part was drafted as per the rules stipulated in GB/T 1.1-2009.
This Part uses redrafting method to modify and adopt IEC 60601-1-12:2014 Medical Electrical
Equipment – Part1-12: General Requirements for Basic Safety and Essential Performance –
Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical
Systems Intended for Use in the Emergency Medical Services Environment.
The major differences between this Part and IEC 60601-1-12:2014 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 9706.1-2020 that modifies and adopts the international standard to replace
IEC 60601-1:2005+AMD1:2012;
 Use YY 9706.102 that modifies and adopts the international standard to replace IEC
60601-1-2:2014;
 Use YY 9706.108 that modifies and adopts the international standard to replace IEC
60601-1-8:2006+AMD1:2012;
 Use YY/T 9706.106 that modifies and adopts the international standard to replace
IEC 60601-1-6:2010+AMD1:2013;
 Use YY 9706.111 that modifies and adopts the international standard to replace IEC
60601-1-11;
 Use GB 4824 that equivalently adopts the international standard to replace CISPR
11:2009;
 Add the quotation of HB 6167.6, HB 6167.18, HB 6167.23.
--- Given that aircraft manufactured at home and abroad are used in China, while retaining
the requirements of foreign standards, the requirements of domestic standards have been
added; and relevant content has been added in 4.1, 10.1.4b) and 11, which is expressed
Medical Electrical Equipment – Part 1-12: General
Requirements for Basic Safety and Essential Performance –
Collateral Standard: Requirements for Medical Electrical
Equipment and Medical Electrical Systems Intended
for Use in the Emergency Medical Services Environment
1 Scope, Object and Related Standards
1.1 * Scope
This Part specifies the requirements for the BASIC SAFETY and ESSENTIAL
PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL
ELECTRICAL SYSTEMS (hereafter referred to as ME EQUIPMENT and ME SYSTEMS),
which are intended for use in the EMERGENCY MEDICAL SERVICES ENVIRONMENT.
This Part applies to the ME EQUIPMENT AND ME SYSTEMS, as indicated in the instructions
for use by their MANUFACTURER, for use in the EMERGENCY MEDICAL SERVICES
ENVIRONMENT (hereinafter referred to as EMS ENVIRONEMENT).
NOTE 1: For the purposes of this Standard, the intent of the MANUFACTURER is indicated in the
instructions for use. The RESPONSIBLE ORGANIZATION and the OPERATOR need to be aware that
any other use outside the MANUFACTURER’S INTENDED USE can result in a HAZARDOUS
SITUATION for the PATIENT.
The EMS ENVIRONMENT includes
– responding to and providing life support at the scene of an emergency to a PATIENT
reported as experiencing injury or illness in a pre-hospital setting, and transporting the
PATIENT, while continuing such life support care, to an appropriate professional
healthcare facility for further care.
– providing monitoring, treatment or diagnosis during transport between professional
healthcare facilities.
This Part does not apply to ME EQUIPMENT and ME SYSTEMS intended solely for use in
the HOME HEALTHCARE ENVIRONMENT covered by YY 9706.111 or solely for use in
professional healthcare facilities covered by GB 9706.1 without the additions of YY 9706.111
or this collateral standard. ME EQUIPMENT and ME SYSTEMS are often not solely intended
supporting methods to be employed. The technical description shall describe methods that can
be employed for longer periods.
NOTE 3: Electrical power supply failure includes failure of the SUPPLY MAINS or any near depletion
of INTERNAL ELECTRICAL POWER SOURCES.
If an INTERNAL ELECTRICAL POWER SOURCE is not provided, ME EQUIPMENT or
ME SYSTEMS with ESSENTIAL PERFORMANCE intended to actively keep alive or
resuscitate a PATIENT shall be equipped with an ALARM SYSTEM that includes at least a
MEDIUM PRIORITY ALARM CONDITION that indicates a power supply failure.
EXAMPLE 2: The SUPPLY MAINS voltage falls below the minimum value required for normal
operation.
If an INTERNAL ELECTRICAL POWER SOURCE is provided, the ME EQUIPMENT or
ME SYSTEM with ESSENTIAL PERFORMANCE intended to actively keep alive or
resuscitate a PATIENT shall be equipped with an automatic switchover from the SUPPLY
MAINS to the INTERNAL ELECTRICAL POWER SOURCE.
NOTE 4: A visual indication of this charging mode is required in 15.4.4 of the general standard.
If an INTERNAL ELECTRICAL POWER SOURCE is used, the ME EQUIPMENT or ME
SYSTEM with ESSENTIAL PERFORMANCE intended to actively keep alive or resuscitate a
PATIENT shall be equipped with an ALARM SYSTEM that includes at least a MEDIUM
PRIORITY TECHNICAL ALARM CONDITION that indicates that the INTERNAL
ELECTRICAL POWER SOURCE is nearing insufficient remaining power for ME
EQUIPMENT operation. This TECHNICAL ALARM CONDITION shall provide for a
sufficient time or for a sufficient number of PROCEDURES for an OPERATOR to act. A
TECHNICAL ALARM CONDITION of at least LOW PRIORITY shall remain active until the
INTERNAL ELECTRICAL POWER SOURCE is returned to a level that is above the ALARM
LIMIT or until it is depleted. It shall not be possible to inactivate the visual ALARM SIGNAL
of this TECHNICAL ALARM CONDITION.
Compliance is checked by inspection, functional testing and inspection of the RISK
MANAGEMENT FILE.
8.3 * Additional requirements for INTERNAL ELECTRICAL POWER SOURCE for
ME EQUIPMENT
ME EQUIPMENT that is not FIXED or PERMANENTLY INSTALLED shall be capable of
being powered in its INTENDED USE for at least 20 min from an INTERNAL ELECTRICAL
POWER SOURCE.
If the INTERNAL ELECTRICAL POWER SOURCE is essential to maintain BASIC SAFETY
or maintain ESSENTIAL PERFORMANCE or control the RISKS associated with the loss of
ESSENTIAL PERFORMANCE, the ME EQUIPMENT shall be equipped with a means for the
OPERATOR to determine the state of the INTERNAL ELECTRICAL POWER SOURCE.