AAMI/IEC 60601-2-16:2008

Medical electrical equipment, Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment

standard by Association for the Advancement of Medical Instrumentation/International Electrotechnical Commission , 11/02/2010

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Identical Versions Available

IEC 60601-2-16 Ed. 3.0 en:2008

April 2008
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
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Specifies the minimum safety requirements for single-patient haemodialysis, haemodiafiltration and haemofiltration equipment. These devices are intended for use either by medical staff or under the supervision of medical expertise, including haemodialysis, haemodiafiltration and haemofiltration equipment operated by the patient. These requirements do not apply to: extracorporeal circuits; dialysers; dialysing fluid concentrates; water purification equipment; and equipment used to perform peritoneal dialysis (see IEC 60601-2-39).

Product Details

Published:: 11/02/2010
ISBN(s):: 1570204020
ANSI:: ANSI Approved
Number of Pages:: 67
File Size:: 1 file , 470 KB
Same As:: IEC 60601-2-16 Ed. 3.0 en:2008
Note:: This product is unavailable in Ukraine, Russia, Belarus

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AAMI/IEC 60601-2-16:2008

Medical electrical equipment, Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment

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IEC 60601-2-16 Ed. 3.0 en:2008

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AAMI/IEC 60601-2-16:2018

AAMI/IEC 60601-2-16:2012