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BS EN ISO 7199:2016+A1:2020

Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)

standard by British Standard / European Standard / International Organization for Standardization , 04/06/2020

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Full Description

This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.

This document also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.

This document also applies to external equipment unique to the use of the oxygenator.

Cross References:
ISO 11135
ISO 17665-1
ISO 15675
ISO 10993-1
ISO 11607-1
ISO 10993-7
ISO 11137-1
ISO 10993-4
ISO 10993-11
ISO 11607-2
ISO 13485
ISO 594-2
ISO 14971
ISO/TS 23810
ISO 8637:2010

Incorporates the following:
Amendment, April 2020

Product Details

Published:: 04/06/2020
ISBN(s):: 9780580518249
Number of Pages:: 36
File Size:: 1 file , 1.8 MB
Product Code(s):: 30368446, 30368446, 30368446
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