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JIS T 3231:2011

JIS T 3231:2011

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Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags

Published By Publication Date Number of Pages
JIS 2011-07-29 19
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This Standard specifies sterile, single-use, extracorporeal hard-shell cardiotomy/ venous reservoir systems and soft venous reservoir bags intended for use as a blood reservoir during cardiopulmonary bypass (CPB) surgery (hereafter referred to as "blood reservoirs").

This Standard applies only to the blood reservoir aspects for multifunctional systems which may have integral components such as blood-gas exchangers (oxygenators), blood filters, defoamers, blood pumps.

NOTE: The International Standard corresponding to this Standard and the symbol of degree of correspondence are as follows.

ISO 15674 : 2001 Cardiovascular implants and artificial organsHard- shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags (MOD)

In addition, symbols which denote the degree of correspondence in the contents between the relevant International Standard and JIS are IDT (identical), MOD (modified), and NEQ (not equivalent) according to ISO/IEC Guide 21-1.

JIS T 3231 : 2005 may be applied until July, 28 in 2014.

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JIS T 3231:2011
$19.50