GB 9706.212-2020 PDF in English
GB 9706.212-2020 (GB9706.212-2020) PDF English
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Medical electrical equipment -- Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
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Standards related to (historical): GB 9706.212-2020
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GB 9706.212-2020: PDF in English GB 9706.212-2020
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.10
C 46
Replacing GB 9706.28-2006
Medical electrical equipment - Part 2-12: Particular
requirements for basic safety and essential performance of
critical care ventilators
(ISO 80601-2-12:2011, MOD)
ISSUED ON: APRIL 09, 2020
IMPLEMENTED ON: MAY 01, 2023
Issued by: State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword ... 4
201.1 Scope, object and related standards ... 10
201.2 Normative references ... 13
201.3 Terms and definitions ... 15
201.4 General requirements ... 20
201.5 General requirements for testing of ME equipment ... 22
201.6 Classification of ME equipment and ME systems ... 23
201.7 ME equipment identification, marking and documents ... 23
201.8 Protection against electrical hazards from ME equipment ... 30
201.9 Protection against mechanical hazards of ME equipment and ME systems ... 30
201.10 Protection against unwanted and excessive radiation hazards ... 35
201.11 Protection against excessive temperatures and other hazards... 35
201.12 Accuracy of controls and instruments and protection against hazardous outputs
... 38
201.13 Hazardous situations and fault conditions of ME equipment ... 53
201.14 Programmable electrical medical systems (PEMS) ... 54
201.15 Construction of ME equipment... 54
201.16 ME systems ... 57
201.17 Electromagnetic compatibility of ME equipment and ME systems ... 57
201.101 Gas connections ... 58
201.102 Requirements for the VBS and accessories ... 60
201.103 * Spontaneous breathing during loss of power supply ... 63
201.104 * Training ... 63
201.105 * Indication of duration of operation ... 64
201.106 Signal input/output part ... 64
201.107 Display loops... 64
201.108 * Timed ventilatory pause ... 65
202 Medical electrical equipment – Part 1-2: General requirements for basic safety and
essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests ... 67
206 Medical electrical equipment – Part 1-6: General requirements for basic safety and
essential performance – Collateral Standard: Usability ... 68
208 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 ... 69
Annex C (Informative) Guide to marking and labelling requirements for ME equipment
and ME systems ... 71
Annex D (Informative) Symbols on marking ... 77
Annex AA (Informative) Particular guidance and rationale ... 78
Annex BB (Informative) Reference to the essential principles ... 102
Bibliography ... 104
Foreword
All technical contents of this Part are mandatory.
GB 9706 consists of the following parts, under the general title Medical electrical
equipment:
— Part 1: General requirements for basic safety and essential performance;
— Part 1-3: General requirements for basic safety and essential performance -
Collateral standard: Radiation protection in diagnostic X-ray equipment;
— Part 2-1: Particular requirements for the basic safety and essential performance of
electron accelerators in the range 1 MeV to 50 MeV;
— Part 2-2: Particular requirements for the basic safety and essential performance of
high frequency surgical equipment and high frequency surgical accessories;
— Part 2-3: Particular requirements for the basic safety and essential performance of
short-wave therapy equipment;
— Part 2-4: Particular requirements for the basic safety and essential performance of
cardiac defibrillators;
— Part 2-5: Particular requirements for the basic safety and essential performance of
ultrasonic physiotherapy equipment;
— Part 2-6: Particular requirements for the basic safety and essential performance of
microwave therapy equipment;
— Part 2-8: Particular requirements for the basic safety and essential performance of
therapeutic X-ray equipment operating in the range 10 kV to 1 MV;
— Part 2-11: Particular requirements for the basic safety and essential performance of
gamma beam therapy equipment;
— Part 2-12: Particular requirements for basic safety and essential performance of
critical care ventilators;
— Part 2-13: Particular requirements for the basics safety and essential performance
of an anaesthetic workstation;
— Part 2-16: Particular requirements for the basic safety and essential performance of
haemodialysis, haemodiafiltration and haemofiltration equipment;
— Part 2-17: Particular requirements for the basic safety and essential performance of
automatically-controlled brachytherapy afterloading equipment;
— Part 2-18: Particular requirements for the basic safety and essential performance of
endoscopic equipment;
— Part 2-19: Particular requirements for the basic safety and essential performance of
infant incubators;
— Part 2-22: Particular requirements for basic safety and essential performance of
surgical, cosmetic, therapeutic and diagnostic laser equipment;
— Part 2-24: Particular requirements for the basic safety and essential performance of
infusion pumps and controllers;
— Part 2-25: Particular requirements for the basic safety and essential performance of
electrocardiographs;
— Part 2-26: Particular requirements for the basic safety and essential performance of
electroencephalographs;
— Part 2-27: Particular requirements for the basic safety and essential performance of
electrocardiographic monitoring equipment;
— Part 2-28: Particular requirements for the basic safety and essential performance of
X-ray tube assemblies for medical diagnosis;
— Part 2-29: Particular requirements for the basic safety and essential performance of
radiotherapy simulators;
— Part 2-36: Particular requirements for the basic safety and essential performance of
equipment for extracorporeally induced lithotripsy;
— Part 2-37: Particular requirements for the basic safety and essential performance of
ultrasonic medical diagnostic and monitoring equipment;
— Part 2-39: Particular requirements for basic safety and essential performance of
peritoneal dialysis equipment;
— Part 2-43: Particular requirements for the basic safety and essential performance of
X-ray equipment for interventional procedures;
— Part 2-44: Particular requirements for the basic safety and essential performance of
X-ray equipment for computed tomography;
— Part 2-45: Particular requirements for the basic safety and essential performance of
mammographie X-ray equipment and mammographie stereotactic devices;
— Part 2-54: Particular requirements for the basic safety and essential performance of
X-ray equipment for radiography and radioscopy;
— Part 2-60: Particular requirements for the basic safety and essential performance of
dental equipment;
— Part 2-63: Particular requirements for the basic safety and essential performance of
dental extra-oral X-ray equipment;
— Part 2-65: Particular requirements for the basic safety and essential performance of
dental intra-oral X-ray equipment;
— Part 2-66: Particular requirements for the basic safety and essential performance of
hearing instruments and hearing instrument systems
This Part is Part 2-12 of GB 9706.
This Part is drafted in accordance with the rules given in GB/T 1.1-2009.
This Part replaces GB 9706.28-2006, Medical electrical equipment - Part 2: Particular
requirements for the safety of lung ventilators - Critical care ventilators. Compared
with GB 9706.28-2006, the main technical changes are as follows:
— MODIFY the scope to include the critical care ventilator and its accessories, where
the characteristics of those accessories can affect the basic safety and essential
performance of the ventilator, and thus not only the critical care ventilator itself
(see 201.1.1; 1.1 of the 2006 edition);
— MODIFY the obstruction of the expiratory limb (continuing airway pressure) alarm
condition requirement (see 201.12.4.107 and 201.12.4.108; 51.108 of the 2006
edition);
— ADD the identification of essential performance for a critical care ventilator and
its accessories (see 201.4.3.101);
— ADD tests for ventilation performance (see 201.12.1.101 and 201.12.1.102);
— ADD tests for mechanical strength (see 201.15.3.5.101);
— ADD new symbols (see 201.7);
— ADD requirements for a critical care ventilator as a component of an ME system
(see 201.16);
— ADD tests for enclosure integrity (water ingress) (see 201.11.6.5.101);
— ADD tests for closed suction survivability of the ventilator (see 201.9.101);
— ADD tests for cleaning and disinfection procedures (see 201.11.6.6);
— ADD consideration of contamination of the breathing gas delivered to the patient
from the gas pathways (see 201.11.6.4).
Medical electrical equipment - Part 2-12: Particular
requirements for basic safety and essential performance of
critical care ventilators
201.1 Scope, object and related standards
GB 9706.1-2020, Clause 1 applies, except as follows:
201.1.1 Scope
Subclause 1.1 of GB 9706.1-2020 is replaced by:
— This Part applies to the basic safety and essential performance of a ventilator
combination with its accessories, hereinafter referred to as ME equipment:
intended to be attended by a professional operator for those patients who are
dependent on mechanical ventilation; and
Note 1: Such ventilators are considered a life-supporting ME equipment or ME system.
— intended for use in critical care environments in a professional healthcare facility
or intended for use in transport within a professional healthcare facility.
Note 2: A critical care ventilator intended for use in transport within a professional
healthcare facility is not considered an emergency and transport ventilator.
This Part is also applicable to those accessories intended by their manufacturer to be
connected to a breathing system, or to a ventilator, where the characteristics of those
accessories can affect the basic safety or essential performance of the ventilator.
This Part is not applicable to ME equipment or an ME system operating in ventilation
modes intended for patients who are not dependent on mechanical ventilation.
Note 3: A critical care ventilator, when operating in such a mode, is not considered life-
supporting ME equipment or ME system.
If a clause or subclause is specifically intended to be applicable to ME equipment only,
or to ME systems only, the title and content of that clause or subclause will say so. If
that is not the case, the clause or subclause applies both to ME equipment and to ME
systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME
systems within the scope of this Part are not covered by specific requirements in this
Part except in GB 9706.1-2020, 7.2.13 and 8.4.1.
across the ventilator breathing system and that such changes to the ventilator
breathing system can adversely affect the ventilator performance.
d) a warning statement to the effect that nebulisation or humidification can increase
the resistance of breathing system filters and that the operator needs to monitor the
breathing system filter frequently for increased resistance and blockage.
If applicable, the instructions for use shall include the following:
e) a warning statement to the effect that the ventilator shall not be used in a hyperbaric
chamber.
f) a warning statement to the effect that the ventilator shall not be used with nitric
oxide.
g) a warning statement to the effect that the ventilator shall not be used with helium
or mixtures with helium.
h) a warning statement to the effect that the ventilator accuracy can be affected by the
gas added by use of a nebuliser.
Check compliance by inspection.
201.7.9.2.8.101 * Additional requirements for start-up procedure
Note: A start-up procedure for this Part is a pre-use functional test that is used to
determine that the ventilator is ready for use.
The instructions for use shall disclose a method by which all of the alarm signals can
be functionally tested to determine if they are operating correctly. Portions of this test
method may be automatically performed by the ventilator or may require operator
action.
Example: Combination of the power-on self-test routines and operator action.
Check compliance by inspection.
201.7.9.2.9.101 * Additional requirements for operating instructions
The instructions for use shall disclose:
a) a listing of the following pressures:
— maximum limited pressure (PLIM max);
— if provided, the rated range to which the maximum working pressure (PW max)
can be set, if adjustable;
— the means by which the maximum working pressure is ensured;
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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