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

Delivery: 9 seconds. Download (and Email) true-PDF + Invoice.
Get Quotation: Click GB 9706.27-2005 (Self-service in 1-minute)
Newer / historical versions: GB 9706.27-2005

Preview True-PDF

Scope

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...

Basic Data

Standard ID	GB 9706.27-2005 (GB9706.27-2005)
Description (Translated English)	Medical electrical equipment. Part 2-24: Particular requirements for the safety of infusion pumps and controllers
Sector / Industry	National Standard
Classification of Chinese Standard	C31
Classification of International Standard	11.040.20
Word Count Estimation	64,613
Date of Issue	2005-11-24
Date of Implementation	2006-08-01
Quoted Standard	GB 9706.1-1995; IEC 60601-1-1988; YY 0505-2005
Adopted Standard	IEC 60601-2-24-1998, IDT
Regulation (derived from)	Announcement of Newly Approved National Standards No. 13 of 2005 (No. 87 overall)
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China, China National Standardization Administration Committee
Summary	This Chinese standard specifies the specific infusion pumps, infusion controllers, syringe pumps and portable infusion pump requirements. These devices by medical personnel and families of patients on prescription and medical advice to use.