BS EN ISO 7199:2017 – TC:2020 Edition
$186.33
Tracked Changes. Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 57 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 33 | Annex ZA(informative)Relationship between this European standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered |
| 39 | Foreword |
| 40 | Introduction |
| 42 | 1 Scope 2 Normative references |
| 43 | 3 Terms and definitions |
| 44 | 4 Requirements 4.1 Biological characteristics 4.1.1 Sterility and non-pyrogenicity 4.1.2 Biocompatibility |
| 45 | 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 |
| 46 | 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 |
| 47 | 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 |
| 48 | 5.4 Performance characteristics 5.4.1 Oxygen and carbon dioxide transfer rates |
| 49 | 5.4.2 Heat exchanger performance factor 5.4.3 Blood cell damage 5.4.4 Shelf life |
| 50 | 5.4.5 Filtration efficiency 5.4.6 Integral arterial filter flow rate 5.4.7 Air-handling capability of integral arterial filter |
| 51 | 6 Information supplied by the manufacturer 6.1 Information on the oxygenator |
| 52 | 6.2 Information on the packaging 6.2.1 Unit container 6.2.2 Shipping container 6.3 Information in the accompanying documents |
| 53 | 6.4 Information in the accompanying documents in a prominent form 7 Packaging |
| 54 | Bibliography |
