YY 0054-2010: Haemodialysis equipment

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Scope

This Standard specifies haemodialysis equipment’s terms and definitions,
classifications and basic parameters, requirements, test methods, inspection
rules, marks, instructions for use, packaging, transport, as well as storage
requirements.
This Standard is applicable to automatic dosing hemodialysis equipment
(hereinafter referred to as the “equipment”).
This Standard is not applicable to.
- Water treatment equipment of hemodialysis use;
- Peritoneal dialysis equipment;
- Hemoperfusion, plasmapheresis, and plasma adsorption device;
- Continuous blood purification equipment;

Basic Data

Standard ID	YY 0054-2010 (YY0054-2010)
Description (Translated English)	Haemodialysis equipment
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C45
Classification of International Standard	11.040.40
Word Count Estimation	19,181
Date of Issue	2010-12-27
Date of Implementation	2012-06-01
Older Standard (superseded by this standard)	YY 0054-2003
Quoted Standard	GB/T 191; GB 9706.1; GB 9706.2; GB/T 9969; GB/T 13074; GB/T 14710; YY/T 0466.1; YY 0598; Chinese Pharmacopoeia 2005
Regulation (derived from)	State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the hemodialysis equipment terms and definitions, classifications and basic parameters, requirements, test methods, test rules, signs, instructions and packaging, transportation and storage requirements. This standard applies to automatic dosing hemodialysis equipment (hereinafter referred to as the device). This standard does not apply to: Hemodialysis water treatment equipment, peritoneal dialysis equipment, hemoperfusion, plasmapheresis, plasma adsorption equipment, continuous blood purification equipment.