BS EN ISO 7199:2016+A1:2020
$167.15
Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 36 |
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.
This document does not apply to
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implanted oxygenators,
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liquid oxygenators,
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extracorporeal circuits (blood tubing),
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separate heat exchangers,
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separate ancillary devices, and
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separate arterial line filter.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | National foreword |
| 4 | European foreword |
| 6 | Endorsement notice Endorsement notice |
| 7 | Annex ZA (informative) Relationship between this European standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered |
| 13 | Foreword |
| 14 | 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 |
| 19 | 4.3.5 Integral arterial filter air handling capability 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 |
| 20 | 5.2.2 Biocompatibility 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 5.4.2.3 Equation 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 | Annex A (informative) Examples of connectors |
