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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Status: Obsolete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 IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
GB 9706.2-2003English914 Add to Cart 4 days [Need to translate] Medical electrical equipment -- Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment Obsolete GB 9706.2-2003
GB 9706.2-1991English599 Add to Cart 4 days [Need to translate] Medical electrical equipment--Particular requirements for safety of haemodialysis equipment Obsolete GB 9706.2-1991

PDF similar to GB 9706.2-2003


Standard similar to GB 9706.2-2003

GB/T 39381.1   YY/T 1680   YY/T 1571   GB 9706.204   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Older Standard (superseded by this standard) GB 9706.2-1991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).

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Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB 9706.2-2003 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.