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 collateral 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, which are intended for use in the emergency medical services environment.
This collateral standard is applicable to ME equipment and ME systems which are intended, as indicated in the instructions for use by their manufacturer, for use in the emergency medical services environment (hereinafter referred to as EMS environment).
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 collateral standard 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 for one environment. Such ME equipment or ME system can be intended for multiple use environments, and as such, if also intended for use in the EMS environment, are within the scope of this standard.
Example: ME equipment or ME system intended for both the EMS environment and the professional healthcare facility environment.
Note 2: EMS environment ME equipment and ME systems can be used in locations with unreliable electrical sources and outdoor environmental conditions.
Note 3: The rationale about clauses and subclauses with asterisk (*) in this collateral standard are indicated in Annex A.
1.2 * Object
The object of this collateral standard is to provide general requirements for ME equipment and ME systems carried to the scene of an emergency and used there, as well as in transport, in situations where the ambient conditions differ from indoor conditions. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.
1.3 Related standards
1.3.1 GB 9706.1
For ME equipment and ME systems, this collateral standard complements GB 9706.1, hereafter referred to as the general standard.
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 9706.112 alone (IEC 60601-1-12);
——“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 are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced documents (including any amendments) applies.
GB/T 2423.5-2019 Environmental testing — Part 2: Test methods — Test Ea and guidance: Shock (IEC 60068-2-27:2008, IDT)
GB/T 2423.7-2018 Environmental testing — Part 2: Test methods — Test Ec: Rough handling shocks, primarily for equipment-type specimens (IEC 60068-2-31:2008, IDT)
GB/T 2423.56-2018 Environmental testing — Part 2: Test methods — Test Fh: Vibration, broadband random and guidance (IEC 60068-2-64:2008, IDT)
GB/T 4208-2017 Degrees of protection provided by enclosure (IP code) (IEC 60529:2013, IDT)
GB 4824 Industrial, scientific and medical equipment — Radio-frequency disturbance characteristics — Limits and methods of measurement (GB 4824-2019, CISPR 11:2015, IDT)
GB 9706.1-2020 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2012, MOD)
HB 6167.6 Environmental conditions and test procedures for airborne equipment of civil airplane — Part 6: Vibration test
HB 6167.18 Environmental conditions and test procedures for airborne equipment of civil airplane — Part 18: Power input test
HB 6167.23 Environmental conditions and test procedures for airborne equipment of civil airplane — Part 23: Emission of radio frequency energy test
YY/T 0466.1-2016 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements (ISO 15223-1:2012, IDT)
YY 9706.102 Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests (YY 9706.102-2021, IEC 60601-1-2:2007, MOD)
YY 9706.108 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, IEC 60601-1-8:2012, MOD)
YY/T 9706.106 Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral standard: Usability (YY/T 9706.106-2021, IEC 60601 60601-1-6:2013, MOD)
YY 9706.111 Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (YY 9706.111-2021, IEC 60601-1-11:2015, MOD)
ISO 7000:2014 Graphical symbols for use on equipment — Registered symbols
ISO 7010:2011+A1:2012+A2:2012+A3:2012+A4:2013+A5:2014 Graphical symbols — Safety colours and safety signs — Registered safety signs
EUROCAE1) ED-14G Environmental conditions and test procedures for airborne equipment
RTCA2) DO-160G Environmental Conditions and Test Procedures for Airborne Equipment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB 9706.1, YY 9706.102, YY 9706.106, YY 9706.108 and YY 9706.111 and the following definitions apply.
Note 1: Where the terms “voltage” and “current” are used in this document, they mean the r.m.s. values of an alternating, direct or composite voltage or current unless stated otherwise.
Note 2: 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 systems.
3.1
* emergency medical services environment (EMS environment)
actual conditions and settings, in which operators interact with the ME equipment or ME system, in and around the scene of an emergency outside of a professional healthcare facility where a patient can be given medical care, basic or advanced life support as well as during professional transport to a professional healthcare facility or between professional healthcare facilities
Example 1: 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.
Example 2: Providing monitoring, treatment or diagnosis during transport between professional healthcare facilities.
Note 1: For the purposes of this standard, use of equipment intended for the EMS environment and temporarily used in the home healthcare environment by emergency medical personnel is considered use in the EMS environment.
Note 2: For the purposes of this standard, the operators of equipment intended for the EMS environment are presumed to be professional medical personnel or personnel with relevant specialized training.
Note 3: Professional healthcare facilities include hospitals, physician offices, freestanding surgical centres, dental offices, freestanding birthing centres, limited care facilities, first aid rooms or rescue rooms and multiple treatment facilities.
Note 4: For the purposes of this standard, transport includes road, rotary and fixed-wing ambulances.
Foreword i
1 Scope, object and related standards
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 (supply) from ME equipment
8 Protection against excessive temperatures and other hazards
9 * Accuracy of controls and instruments and protection against hazardous outputs
10 Construction of ME equipment
11 Additional requirements for electromagnetic compatibility of ME equipment and ME systems
Annex A (Informative) General guidance and rationale
Annex B (Informative) Guide to marking and labelling requirements for ME equipment and ME systems
Annex C (Informative) Symbols on marking
Bibliography
