AAMI 15674 2016
$65.83
ANSI/AAMI/ISO 15674:2016 – Cardiovascular implants and artificial organs – Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
| Published By | Publication Date | Number of Pages |
| AAMI | 2016 | 21 |
Specifies requirements for 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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 15674:2016; Cardiovascular implants and artificial organs—Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags |
| 2 | Objectives and uses of AAMI standards andrecommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents page |
| 6 | Glossary of equivalent standards |
| 7 | Committee representation |
| 8 | Background of AAMI adoption of ISO 15674:2016 |
| 9 | Foreword |
| 11 | 1 Scope 2 Normative references 3 Terms and definitions |
| 13 | 4 Requirements 4.1 Biological characteristics 4.1.1 Sterility and non-pyrogenicity 4.1.2 Biocompatibility |
| 14 | 4.2 Physical characteristics 4.2.1 General 4.2.2 Blood volumes 4.2.3 Connectors 4.3 Performance characteristics 4.3.1 Blood cell damage 4.3.1.1 Plasma-free haemoglobin 4.3.1.2 Platelet reduction and white blood cell reduction 4.3.2 Air-handling capacity 4.3.3 Priming volume of the reservoirs in accordance with the manufacturer’s quality control management system 4.3.4 Defoaming characteristics |
| 15 | 4.3.5 Volume calibration 4.3.6 Filtration efficiency 4.3.7 Break-through volume 4.3.8 Dynamic priming volume 4.3.9 Minimum and maximum volumes 4.3.10 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 |
| 16 | 5.2.2 Biocompatibility 5.3 Physical characteristics 5.3.1 Blood pathway integrity for soft venous reservoir bags 5.3.2 Blood pathway integrity for sealed hard-shell reservoirs 5.3.3 Connectors 5.3.4 Blood cell damage 5.3.4.1 Test media 5.3.4.2 Procedure Table 1 — Conditions for in vitro testing of blood cell damage |
| 17 | Table 2 — Sampling schedule 5.3.5 Filtration efficiency 5.3.5.1 Test liquid 5.3.5.2 Procedure 5.3.6 Shelf life 6 Information supplied by the manufacturer 6.1 Information on the reservoir (labelling) |
| 18 | 6.2 Information on the packaging 6.2.1 Information on the unit container 6.2.2 Information on the shipping container 6.3 Information in the accompanying documents |
| 19 | 6.4 Information in the accompanying documents in a prominent form 7 Packaging |
| 20 | Annex A (normative) Factors to be considered in evaluating performance characteristics |
| 21 | Bibliography |
