GB 9706.213-2021 (GB9706.213-2021) & related versions
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Medical electrical equipment -- Part 2-13: Particular requirements for the basics safety and essential performance of an anaesthetic workstation
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GB 9706.213-2021
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GB 9706.213-2021
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GB 9706.213-2021: PDF in English
GB 9706.213-2021
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.10
CCS C 46
Replacing GB 9706.29-2006
Medical electrical equipment - Part 2-13: Particular
requirements for the basic safety and essential performance
of an anaesthetic workstation
(ISO 80601-2-13:2011, MOD)
ISSUED ON: DECEMBER 01, 2021
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
Introduction ... 10
201.1 Scope, object and related standards ... 12
201.2 Normative references ... 15
201.3 Terms and definitions ... 17
201.4 General requirements ... 23
201.5 General requirements for testing ME equipment ... 25
201.6 Classification of ME equipment and ME systems ... 25
201.7 ME equipment identification, marking and documents ... 25
201.8 Protection against electrical hazards from ME equipment ... 31
201.9 Protection against mechanical hazards of ME equipment and ME systems 31
201.10 Protection against unwanted and excessive radiation hazards ... 33
201.11 Protection against excessive temperatures and other hazards... 34
201.12 Accuracy of controls and instruments and protection against hazardous
outputs 36
201.13 Hazardous situations and fault conditions of ME equipment ... 43
201.14 Programmable electrical medical systems (PEMS) ... 43
201.15 Construction of ME equipment... 44
201.16 ME systems ... 44
201.17 Electromagnetic compatibility of ME equipment and ME systems ... 46
201.101 Additional requirements for anaesthetic gas delivery systems ... 46
201.102 Additional requirements for an anaesthetic breathing system ... 53
201.103 Additional requirements for an anaesthetic gas scavenging system ... 64
201.104 Additional requirements for an anaesthetic vapour delivery system ... 70
201.105 Additional requirements for an anaesthetic ventilator ... 76
201.106 Display loops ... 84
201.107 Clinical evaluation ... 85
202 Electromagnetic compatibility - Requirements and tests ... 85
203 General requirements for radiation protection in diagnostic X-ray equipment85
206 Usability ... 85
208 General requirements, tests and guidance for alarm systems in ME equipment
and ME systems ... 86
209 Requirements for environmentally conscious design ... 87
210 Process requirements for the development of physiologic closed-loop
controllers ... 87
211 Requirements for ME equipment and ME systems used in the home
healthcare environment ... 88
Annex ... 89
Annex C (informative) Guide to marking and labelling requirements for ME
equipment and ME systems or their parts ... 90
Annex D (informative) Symbols on marking ... 100
Annex AA (informative) Particular guidance and rationale ... 102
Annex BB (normative) Test for flammability of anaesthetic agent ... 122
Annex CC (informative) Environmental aspects ... 123
Bibliography ... 126
Foreword
This document was drafted in accordance with the rules given in GB/T 1.1-2020
"Directives for standardization - Part 1: Rules for the structure and drafting of
standardizing documents".
This document is Part 2-13 of GB 9706 "Medical electrical equipment". The
following parts of GB 9706 have been issued:
- 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 2-5: 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 basic 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 after-loading 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 2-24: 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 mammographic X-ray equipment and mammographic 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.
This document replaces GB 9706.29-2006 "Medical electrical equipment -- Part 2:
Particular requirements for the safety and essential performance of anaesthetic
systems". Compared with GB 9706.29-2006, in addition to the structural and
editorial changes, the main technical changes in this document are as follows:
- Add essential performance (see 201.4.3);
- Add gas flow rate and leakage specifications (see 201.5.101.2);
- Add mass of mobile equipment (see 201.7.2.21);
- Add devices containing phthalates (see 201.7.2.105);
- Add anaesthetic workstations intended to be mounted to a wall or ceiling
pendant (see 201.7.9.3.102);
- Add mechanical hazards associated with moving parts (see 201.9.2);
- Delete the protection against the danger of ignition of flammable anesthetic
mixtures in Clause 6;
- Delete Clause 43 Fireproof;
- Add hazardous situations and fault conditions of ME equipment (see 201.13);
- Add programmable electrical medical systems (PEMS) (see 201.14);
- Add additional requirements for signal input/output part (see 201.16.101);
- Add interface to interchangeable anaesthetic vapour delivery systems (see
201.101.10);
- Add additional requirements for an anaesthetic breathing system (see 201.102);
- Add additional requirements for an anaesthetic gas scavenging system (see
201.103);
- Add additional requirements for an anaesthetic vapour delivery system (see
201.104);
- Add additional requirements for an anaesthetic ventilator (see 201.105);
- Add display loops (see 201.106);
- Add clinical evaluation (see 201.107);
Medical electrical equipment - Part 2-13: Particular
requirements for the basic safety and essential performance
of an anaesthetic workstation
201.1 Scope, object and related standards
Clause 1 of the General Standard applies, except as follows:
201.1.1 * Scope
Replacement:
This document is applicable to the basic safety and essential performance of an
anaesthetic workstation for administering inhalational anesthesia whilst continuously
attended by a professional operator.
This document specifies particular requirements for a complete anaesthetic
workstation and the following anaesthetic workstation components which, although
considered as individual devices in their own right, may be utilized, in conjunction
with other relevant anaesthetic workstation components, to form an anaesthetic
workstation to a given specification:
- anaesthetic gas delivery system;
- anaesthetic breathing system;
- anaesthetic gas scavenging system;
- anaesthetic vapour delivery system;
- anaesthetic ventilator;
- monitoring equipment;
- alarm system;
- protection device.
NOTE 1: Monitoring equipment, alarm systems and protection devices are summarized in Table
AA.1.
An anaesthetic workstation supplied complete and its individual components are
considered as ME equipment or ME systems with regard to the General Standard.
201.11 Protection against excessive temperatures and other
hazards
General Standard, Clause 11 applies, except as follows:
201.11.6.3 Spillage on ME equipment and ME systems
Replacement:
The Anaesthetic workstation and its individual components shall be so constructed
that spillage does not wet parts which, when wetted, pose an unacceptable risk.
Check compliance by the following test:
Test the anaesthetic workstation and its individual components under the least
favorable specified working conditions, but in accordance with the instructions for
use. pour a quantity of 200 mL of normal tap water steadily on an arbitrary point on
the top surface of the anaesthetic workstation and its individual components, for
approximately 15 s, from a height not exceeding 5 cm. after the test, the anaesthetic
workstation and its individual components shall comply with all the requirements of
this document for normal condition.
201.11.6.8 Compatibility with substances used with the ME equipment
Addition:
The anaesthetic workstation and its individual components shall be designed and
manufactured to minimize health risks due to substances leached or leaking from the
anaesthetic workstation or its individual components during normal use. particular
attention shall be paid to the toxicity of materials and their compatibility with
substances and gases with which they come into contact during normal use.
NOTE: Attention is drawn to substances which are carcinogenic, mutagenic or toxic to
reproduction.
201.11.8 Interruption of the power supply/supply mains to ME equipment
Addition:
201.11.8.101 * General requirements
The instructions for use shall describe the functioning of the anaesthetic workstation
or its individual components after interruption of the power supply, and where
applicable following a switchover to an internal electrical power source. particular
emphasis shall be placed on the flow rate and composition of the fresh gas and the
behaviour of any operator-accessible gas power supply outlet under these
......
| Standard ID | GB 9706.213-2021 (GB9706.213-2021) | | Description (Translated English) | Medical electrical equipment -- Part 2-13: Particular requirements for the basics safety and essential performance of an anaesthetic workstation | | Sector / Industry | National Standard | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.040.10 | | Word Count Estimation | 84,835 | | Date of Issue | 2021-12-01 | | Date of Implementation | 2023-05-01 | | Older Standard (superseded by this standard) | GB 9706.29-2006 | | Adopted Standard | ISO 80601-2-13-2011, MOD | | Drafting Organization | Shenzhen Mindray Biomedical Electronics Co., Ltd. | | Administrative Organization | National Technical Committee on Standardization of Anesthesia and Respiratory Equipment | | Regulation (derived from) | National Standard Announcement No. 15 of 2021 | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Administration for Market Regulation, National Standardization Administration |
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