GB 9706.27-2005Medical electrical equipment -- Part 2-24: Particular requirements for the safety of infusion pumps and controllers (English PDF)

Foreword

There are series of standards of medical electrical equipment, which mainly

consist of two parts.

- Part 1.general safety requirements for medical electrical equipment;

- Part 2.particular requirements for medical electrical equipment.

This Particular Standard is particular requirements for the safety of infusion

pumps and controllers of Part 2.This Standard identically uses IEC 60601-2-

2005 Medical electrical equipment Part 1-2.General requirements for safety -

Collateral standards. Electromagnetic compatibility - Requirements and tests

(IEC 60601-1-2.2001, IDT) as references.

Annex L, Annex AA of this Particular Standard are informative; Annex BB is

normative.

This Particular Standard was proposed by Sub-committee on Medical

Electronic Equipment of National Technical Committee on Medical Electrical

Equipment of Standardization Administration of China.

This Particular Standard shall be under the jurisdiction of Sub-committee on

Medical Electronic Equipment of National Technical Committee on Medical

Electrical Equipment of Standardization Administration of China.

The drafting organization of this Particular Standard. Shanghai Institute of

Medical Instrumentation.

Main drafters of this Particular Standard. Xu Yuemin, Liu Qun.

Medical electrical equipment - Part 2-24.Particular

requirements for the safety of infusion pumps and

controllers

SECTION ONE - GENERAL

The clauses and sub-clauses of this section of the General Standard and of this

section of the Collateral Standard YY 0505-2005 apply, except as follows.

1 Scope and object

The clause of the General Standard and this clause of the Collateral Standard

YY 0505-2005 apply, except as follows.

1.1* Scope

Addition.

This Particular Standard specifies the requirement for infusion pumps, infusion

controllers, syringe pumps and pumps for ambulatory use, as defined in 2.101

to 2.110.These devices are intended for use by medical staff and home patients

as prescribed and medically indicated. These particular requirements do not

apply to devices.

- specifically intended for diagnostic or similar use (e.g. angiography or

other pumps permanently controlled or supervised by the operator);

- enteral infusion;

- extracorporeal circulation of blood;

- implantable or disposable devices;

- equipment specially intended for diagnostic use within urodynamics

(measurement of pressure-volume relationship of the urinary bladder

when filled through a catheter with water);

- equipment specially intended for diagnostic use within male impotence

testing (measurement of amount of liquid infused, necessary to maintain

a preset pressure level for maintaining penile erection. cavernosometry,

cavernosography).

Annex BB

(Normative)

Normative references

The provisions in following documents become the provisions of this Standard

through reference in this Standard. For dated references, the subsequent

amendments (exc...

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