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BS EN ISO 7199:2017

BS EN ISO 7199:2017

$142.49

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

Published By Publication Date Number of Pages
BSI 2017 30
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PDF Catalog

PDF Pages PDF Title
6 Annex ZA(informative)Relationship between this European standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
12 Foreword
13 Introduction
15 1 Scope
2 Normative references
16 3 Terms and definitions
17 4 Requirements
4.1 Biological characteristics
4.1.1 Sterility and non-pyrogenicity
4.1.2 Biocompatibility
18 4.2 Physical characteristics
4.2.1 Blood pathway integrity
4.2.2 Heat exchanger fluid pathway integrity
4.2.3 Blood volumes
4.2.4 Connectors
4.3 Performance characteristics
4.3.1 Oxygen and carbon dioxide transfer rates
4.3.2 Heat exchanger performance factor
4.3.3 Integral arterial filtration efficiency
4.3.4 Integral arterial filter flow rate capacity
4.3.5 Integral arterial filter air handling capability
19 4.3.6 Blood cell damage
4.3.7 Time-dependent performance changes
4.3.8 Shelf life
5 Tests and measurements to determine compliance with this document
5.1 General
5.2 Biological characteristics
5.2.1 Sterility and non-pyrogenicity
5.2.2 Biocompatibility
20 5.3 Physical characteristics
5.3.1 Blood pathway integrity
5.3.2 Heat exchanger water pathway integrity
5.3.3 Blood volumes
5.3.4 Connectors
21 5.4 Performance characteristics
5.4.1 Oxygen and carbon dioxide transfer rates
22 5.4.2 Heat exchanger performance factor
5.4.3 Blood cell damage
5.4.4 Shelf life
23 5.4.5 Filtration efficiency
5.4.6 Integral arterial filter flow rate
5.4.7 Air-handling capability of integral arterial filter
24 6 Information supplied by the manufacturer
6.1 Information on the oxygenator
25 6.2 Information on the packaging
6.2.1 Unit container
6.2.2 Shipping container
6.3 Information in the accompanying documents
26 6.4 Information in the accompanying documents in a prominent form
7 Packaging
27 Bibliography

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BS EN ISO 7199:2017
$142.49