GB 9706.213-2021 Active National standards force_standard

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

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

Publish Date: 2021-12-01 Implement Date: 2023-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: GB 9706.213-2021

Standard Type: National standards

Standard Status: Active

is_force_gb: yes

CCS Name: Surgical room equipment

ICS Name: Anesthesia, respiration, and resuscitation equipment

Publish Date: 2021-12-01

Implement Date: 2023-05-01

Pages: 84 pages

Scope

This part of GB 9706 specifies the general requirements for the basic safety and basic performance of ME equipment and ME systems.
This part applies to medical electrical equipment and medical electrical systems (hereinafter referred to as ME equipment and ME systems).
If a chapter or clause explicitly states that it only applies to ME equipment or ME systems, the title and the text of the chapter or clause will indicate this. If this is not the case, the relevant chapter or clause applies to both ME equipment and ME systems.
Except for 7.2.13 and 8.4.1, the hazards (sources) caused by the intended physiological effects of ME equipment or ME systems within the scope of this part are not specifically required in this part.
This document applies to the basic safety and basic performance of anesthesia workstations used for administering inhaled anesthesia, which require the continuous involvement of professional operators.
This document specifies dedicated requirements for a complete anesthesia workstation and the following anesthesia workstation components. These anesthesia workstation components can be used as standalone equipment or may form an anesthesia workstation with other related anesthesia workstation components:
——Anesthesia gas delivery systems;
——Anesthesia respiratory systems;
——Anesthesia gas purification systems;
——Anesthesia gas delivery devices;
——Anesthesia ventilators;
——Monitoring devices;
——Alarm systems;
——Protective devices.
Note 1: Table AA.1 outlines the monitoring devices, alarm systems, and protective devices.
Considering the general standards, both the complete anesthesia workstation and its independent components are considered ME equipment or ME systems.
Note 2: Table AA.2 provides the usage environment of this document.
This document also applies to accessories claimed by manufacturers to be connected to anesthesia workstations, if the c

Development Information

Word Count: 162 Thousand words Pages: 84 pages

Same series standard

GB 9706.202-2021 Medical electrical equipment—Part 2-2:Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories GB 9706.208-2021 Medical electrical 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 GB 9706.216-2021 Medical electrical equipment—Part 2-16:Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment GB 9706.218-2021 Medical electrical equipment—Part 2-18:Particular requirements for the basic safety and essential performance of endoscopic equipment GB 9706.219-2021 Medical electrical equipment—Part 2-19:Particular requirements for the basic safety and essential performance of infant incubators GB 9706.224-2021 Medical electrical equipment—Part 2-24:Particular requirements for the basic safety and essential performance of infusion pumps and controllers GB 9706.225-2021 Medical electrical equipment—Part 2-25:Particular requirements for the basic safety and essential performance of electrocardiographs GB 9706.226-2021 Medical electrical equipment—Part 2-26:Particular requirements for the basic safety and essential performance of electroencephalographs GB 9706.227-2021 Medical electrical equipment—Part 2-27:Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment GB 9706.229-2021 Medical electrical equipment—Part 2-29:Particular requirements for the basic safety and essential performance of radiotherapy simulators GB 9706.236-2021 Medical electrical equipment—Part 2-36:Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy GB 9706.239-2021 Medical electrical equipment—Part 2-39:Particular requirements for basic safety and essential performance of peritoneal dialysis equipment GB 9706.243-2021 Medical electrical equipment—Part 2-43:Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures GB 9706.265-2021 Medical electrical equipment—Part 2-65:Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment

Replace the following standards

GB 9706.29-2006 Medical electrical equipment—Part 2:Particular requirements for the safety and essential performance of anaesthetic systems

Referenced Standards

YY 0505-2012 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests YY/T 0664-2008 Medical device software—Software life cycle processes YY 0709-2009 Medical electrical equipment—Part 1-8:General requirements for safety—Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems ISO 2882 ISO 3864-1:2002 ISO 7000:2004 ISO 7010:2011 ISO 9614-1 ISO 80000-1:2009 IEC 60601-1-6 IEC 60730-1:2010 IEC 60851-3:2009 IEC 60851-5:2008 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 YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests YY/T 9706.106-2021 Medical electrical equipment—Part 1-6:General requirements for basic safety and essential performance—Collateral Standard:Usability YY 9706.108-2021 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/T 9706.110-2021 Medical electrical equipment—Part 1-10:General requirements for basic safety and essential performance—Collateral Standard: Requirements for the development of physiologic closed-loop controllers GB/T 1962.2-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment—Part 2:Lock fittings GB 3836.4-2000 Electrical apparatus for explosive gas atmospheres—Part 4:Intrinsic safety“i” GB 3836.4-2010 Explosive atmospheres—Part 4:Equipment protection by intrinsic safety "i" GB/T 3836.4-2021 Explosive atmospheres—art 4:Equipment protection by intrinsic safety “i” GB 3836.11-1991 Electrical apparatus for explosive atmospheres-Method of test for ascertainment of maximum experimental safe gap GB/T 3836.11-2008 Explosive atmospheres—Part 11:Equipment protection by flameproof enclosures “d”—Method of test for ascertainment of maximum experimental safe gap GB/T 3836.11-2017 Explosive atmospheres—Part 11:Material characteristics for gas and vapour classification—Test methods and data GB/T 3836.11-2022 Explosive atmospheres—Part 11:Material characteristics for gas and vapour classification—Test methods and data GB/T 4999-2003 Anaesthetic and respiratory equipment—Vocabulary GB/T 7899-2006 Regulators for welding, cutting and the similar processes GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB/T 15383-2011 Connection types and dimensions for gas cylinder valve outlets GB 50751-2012 Technical code for medical gases engineering YY 0339-2002 Suction catheter for use in the respiratory tract YY 0339-2009 Suction catheter for use in the respiratory tract YY/T 0339-2019 Suction catheters for use in the respiratory tract YY/T 0339-2024 Suction catheters for use in the respiratory tract YY/T 0461-2003 Breathing tubes intended for use with aneasthetic apparatus and ventilators YY 0601-2007 Anaesthetic gas monitors YY 0601-2009 The basic safety and main performance specific requirements for medical electrical equipment respiratory gas monitoring devices YY 0636.1-2008 Medical suction equipment—Part 1:Electrically powered suction equipment—Safety requirements YY/T 0636.1-2021 Medical suction equipment—Part 1:Electrically powered suction equipment YY 0636.3-2008 Medical suction equipment—Part 3:Suction equipment powered from a vacuum or pressure source YY/T 0636.3-2021 Medical suction equipment—Part 3:Suction equipment powered from a vacuum or possitive pressure gas source YY/T 0664-2008 Medical device software—Software life cycle processes YY/T 0664-2020 Medical device software—Software life cycle processes YY/T 0755-2009 Anaesthetic vaporizers—Agent-specific filling systems YY/T 0799-2010 Low-pressure hose assemblies for use with medical gases YY/T 0801.1-2010 Terminal units for medical gas pipeline systems—Part 1:Terminal units for use with compressed medical gases and vacuum YY/T 0801.2-2010 Terminal units for medical gas pipeline systems—Part 2:Terminal units for anaesthetic gas scavenging systems YY/T 0978-2016 Anaesthetic reservoir bags YY 1040.1-2003 Anaesthetic and respiratory equipment—Conical connectors—Part 1:Cones and sockets YY/T 1040.1-2015 Anaesthetic and respiratory equipment—Conical connectors—Part 1:Cones and sockets YY/T 1040.2-2008 Anaesthetic and respiratory equipment—Conical connectors—Part 2:Screw-threaded weight-bearing connectors ISO 407:2004 ISO 7396-2:2007

Adopt standards

ISO 80601-2-13:2011+AMD1:2015+AMD2:2018

Related Standards

GB 11246-1989 Abolished

GB 11246-1989 Specifications for continuous flow inhalational anaesthetic machines for use with humans

Publish Date: 1989-03-31

YY 0339-2002 Replaced

YY 0339-2002 Suction catheter for use in the respiratory tract

Publish Date: 2002-09-24

YY/T 0337.1-2002 Active

YY/T 0337.1-2002 Tracheal tubes Part 1:—Commonly-used tubes and connectors

Publish Date: 2002-09-24

YY/T 0337.2-2002 Active

YY/T 0337.2-2002 Tracheal tubes—Part 2:Cole type tube

Publish Date: 2002-09-24

YY/T 0338.1-2002 Replaced

YY/T 0338.1-2002 Tracheostomy tubes—Part 1:Tubes and connectors for adults

Publish Date: 2002-09-24

YY/T 0338.2-2002 Replaced

YY/T 0338.2-2002 Tracheostomy tubes—Part 2:Paediatric tracheostomy tubes

Publish Date: 2002-09-24