GB 9706.213-2021 English PDF (GB9706.213-2021)

Delivery: 3 seconds. Download true-PDF + Invoice.
Get QUOTATION in 1-minute: Click GB 9706.213-2021
Historical versions: GB 9706.213-2021
Preview True-PDF (Reload/Scroll if blank)

GB 9706.213-2021: Medical electrical equipment -- Part 2-13: Particular requirements for the basics safety and essential performance of an anaesthetic workstation
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 ma...