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Database: 189759 (19 Oct 2025)
GB 9706.2-2003 English PDF
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GB 9706.2-2003
: Medical electrical equipment -- Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
Status: Obsolete
GB 9706.2: Evolution and historical versions
Standard ID
Contents [version]
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Standard Title (Description)
Status
PDF
GB 9706.2-2003
English
914
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Medical electrical equipment -- Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
Obsolete
GB 9706.2-2003
GB 9706.2-1991
English
599
Add to Cart
4 days [Need to translate]
Medical electrical equipment--Particular requirements for safety of haemodialysis equipment
Obsolete
GB 9706.2-1991
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GB 9706.222
GB 9706.255
Basic data
Standard ID
GB 9706.2-2003 (GB9706.2-2003)
Description (Translated English)
Medical electrical equipment-Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
Sector / Industry
National Standard
Classification of Chinese Standard
C45
Classification of International Standard
11.040.20
Word Count Estimation
23,279
Date of Issue
2003-10-09
Date of Implementation
2004-06-01
Older Standard (superseded by this standard)
GB 9706.2-1991
Adopted Standard
IEC 60601-2-16-1998, IDT
Regulation (derived from)
China Announcement of Newly Approved National Standards No. 13 of 2003 (No. 61 overall)
Issuing agency(ies)
General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China
Summary
This Chinese standard specifies the dedicated single use hemodialysis, hemodiafiltration and hemofiltration device (see 2. 101 define) the minimum security requirements. These devices are used for medical personnel or for use under the supervision of experts, including the operation by the patient hemodialysis, hemodiafiltration and hemofiltration settings. These requirements do not apply to in vitro dedicated piping, dialyzer, dialysate concentrate, water purification equipment, peritoneal dialysis equipment (IEC 60601-2-39: 1999).