Partners save 15% on every standard

Valid

GB 9706.224-2021Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers (English PDF)

Also coversGB9706.224-2021

Open the GB 9706.224-2021 preview as PDF

Preview — first pages of GB 9706.224-2021

This is a limited preview

Buy now to download the full PDF

Issued by

SAMR; SAC

Level / Type

National · Mandatory

Issue date

December 1, 2021

Implementation date

May 1, 2023

Scope

GB 9706.224-2021 (Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers) is available as an English-translated PDF.

GB 9706.224-2021 — Replacement. This particular standard specifies the requirements for ENTERAL NUTRITION PUMPS, INFUSION PUMPS, INFUSION PUMPS FOR AMBULATORY USE, SYRINGE OR CONTAINER PUMPS, VOLUMETRIC INFUSION CONTROLLERS and VOLUMETRIC INFUSION PUMPS, as defined in 201.3.204, 201.3.206, 201.3.207, 201.3.220, 201.3.222 and 201.3.223. This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFUSION PUMPS and VOLUMETRIC INFUSION CONTROLLERS, hereafter referred to as ME EQUIPMENT. This standard applies to ADMINISTRATION SETS as far as their characteristics influence the BASIC SAFETY or ESSENTIAL PERFORMANCE of INFUSION PUMPS and VOLUMETRIC INFUSION CONTROLLERS. However this Standard does not specify requirements or tests for other aspects of ADMINISTRATION SETS. 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 Standard are not covered by specific requirements in this Standard except in 7.2.13 and 8.4.1 of the general standard. Note. See also 4.2 of the general standard. This Standard does not apply to the following. a) devices specifically intended for diagnostic or similar use (e.g., angiography or other pumps permanently controlled or supervised by the OPERATOR); ......

Document preview — GB 9706.224-2021

National Standard of the People's Republic of China

Issued by: SAMR; SAC

Foreword...3
Introduction...8
201.1 Scope, object and related standards...10
201.2 Normative references...12
201.3 Terms and definitions...13
201.4 General requirements...17
201.5 General requirements for testing of ME EQUIPMENT...19
201.6 Classification of ME EQUIPMENT and ME SYSTEMS...19
201.7 ME EQUIPMENT identification, marking and documents...19
201.8 Protection against electrical HAZARDS from ME EQUIPMENT...24

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 2-24 of GB 9706, Medical electrical equipment. The following

parts have been published under GB 9706.

-- 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 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 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;

Medical electrical equipment - Part 2-24.Particular

requirements for the basic safety and essential performance

of infusion pumps and controllers

201.1 Scope, object and related standards

Clause 1 of the general standard applies, except as follows.

201.1.1 Scope

Replacement.

This particular standard specifies the requirements for ENTERAL NUTRITION

PUMPS, INFUSION PUMPS, INFUSION PUMPS FOR AMBULATORY USE,

SYRINGE OR CONTAINER PUMPS, VOLUMETRIC INFUSION CONTROLLERS

and VOLUMETRIC INFUSION PUMPS, as defined in 201.3.204, 201.3.206,

201.3.207, 201.3.220, 201.3.222 and 201.3.223.

This particular standard applies to the BASIC SAFETY and ESSENTIAL

PERFORMANCE of INFUSION PUMPS and VOLUMETRIC INFUSION

CONTROLLERS, hereafter referred to as ME EQUIPMENT.

This standard applies to ADMINISTRATION SETS as far as their characteristics

influence the BASIC SAFETY or ESSENTIAL PERFORMANCE of INFUSION

PUMPS and VOLUMETRIC INFUSION CONTROLLERS. However this Standard

does not specify requirements or tests for other aspects of ADMINISTRATION SETS.

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 Standard are not covered by specific

requirements in this Standard except in 7.2.13 and 8.4.1 of the general standard.

Note. See also 4.2 of the general standard.

This Standard does not apply to the following.

a) devices specifically intended for diagnostic or similar use (e.g., angiography

or other pumps permanently controlled or supervised by the OPERATOR);

......

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — all pages — is available in the English PDF.

Referenced standards

Cited by

How to Buy GB 9706.224-2021

1Add to cart. Click the "Buy GB 9706.224-2021" button on this page. You can add more standards before checkout.
2Checkout. Enter your email and billing details. Payment is processed securely by Stripe (cards, Apple Pay, Google Pay supported).
3Instant delivery (0–9 sec). Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
4Invoice included. A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.