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

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