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YY 9706.112-2021Medical 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 (English PDF)

医用电气设备第1-12部分：基本安全和基本性能的通用要求并列标准：预期在紧急医疗服务环境中使用的医用电气设备和医用电气系统的要求

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

March 9, 2021

Implementation date

May 1, 2023

Scope

YY 9706.112-2021 is the English-translated version of 医用电气设备第1-12部分：基本安全和基本性能的通用要求并列标准：预期在紧急医疗服务环境中使用的医用电气设备和医用电气系统的要求.

YY 9706.112 is the collateral standard for medical electrical equipment used in emergency medical services: in ambulances, at roadsides and in helicopters.

It adds to the general safety standard the requirements that follow from that environment rather than from any one device type, covering mechanical shock and vibration, temperature and humidity extremes, ingress of water and dust, operation on vehicle power and on battery, electromagnetic conditions in a vehicle, and legibility and operability by a clinician wearing gloves in poor light.

A monitor or a ventilator qualified for a ward is not thereby qualified for an ambulance. Being a YY standard without the /T suffix, compliance is compulsory in China.

It took effect in May 2023, and any device claiming EMS use is assessed against it.

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Document preview — YY 9706.112-2021

National Standard of the People's Republic of China

Issued by: National Medical Products Administration

Foreword3
1 Scope, Object and Related Standards5
2 Normative References6
3 Terms and Definitions8
4 General Requirements9
5 * Classification of ME EQUIPMENT and ME SYSTEMS15
6 ME EQUIPMENT Identification, Marking and Documents15
7 * Protection against Electrical HAZARDS from ME EQUIPMENT19
8 Protection against Excessive Temperatures and Other HAZARDS19
10 Construction of ME EQUIPMENT23
11 Additional Requirements for Electromagnetic Compatibility of ME EQUIPMENT23
And ME SYSTEMS28
Annex A (Informative) General Guidance and Rationale29
Annex B (Informative) Guide to Marking and Labelling Requirements for ME29
EQUIPMENT and ME SYSTEMS51
Annex C (Informative) Symbols on Marking54
Bibliography56

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

1 Scope, Object and Related Standards

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.

Remaining clauses in the full document

2 Normative References
3 Terms and Definitions
4 General Requirements
5 * Classification of ME EQUIPMENT and ME SYSTEMS
6 ME EQUIPMENT Identification, Marking and Documents
7 * Protection against Electrical HAZARDS from ME EQUIPMENT
8 Protection against Excessive Temperatures and Other HAZARDS
10 Construction of ME EQUIPMENT
11 Additional Requirements for Electromagnetic Compatibility of ME EQUIPMENT

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 60 pages — is available in the English PDF.

Similar standards

YY/T 9706.106|YY 9706.108|YY 9706.111|YY 9706.287

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