YY 0053-2008 in English
SUPERSEDEDCardiovascular implants and artificial organs—Haemodialysers haemodiafilters haemofilters and haemoconcentrators
- Issued on:2008-04-25
- Implemented on:2009-12-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$136.00
本标准规定了在人体上使用的血液透析器,血液透析滤过器,血液滤过器和血液浓缩器的技术要求。
Scope
This standard specifies the technical requirements for hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators used on the human body. The "devices" involved in this article specifically refer to the above products. This standard does not apply to:
——extracorporeal circulation blood lines;
——plasma separators;
——blood perfusion devices;
——vascular access devices;
——blood pumps;
——pressure monitors for extracorporeal circulation blood lines - Air monitors;
——Systems for preparing, supplying and monitoring dialysate;
——Systems for performing hemodialysis, hemofiltration or hemodiafiltration treatments;
——Reprocessing steps and equipment.

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