AAMI AT6 2013
$75.64
ANSI/AAMI AT6:2013 – Autologous transfusion devices
| Published By | Publication Date | Number of Pages |
| AAMI | 2013 | 27 |
This standard establishes labeling and performance requirements, test methods, and terminology that will help define a reasonable level of safety and efficacy for autologous transfusion devices. Specifically, it includes requirements for sterile, disposable systems and associated electromechanical hardware designed to collect and filter or process, or both, extravasated blood for reinfusion of erythrocytes or filtered whole blood into the patient’s circulation. Aspects of these systems related to collection, anticoagulation (systemic and device), storage, processing and filtration, and reinfusion are within the scope of this standard.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI AT6:2013, Autologous transfusion devices |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 7 | Committee representation |
| 8 | Foreword |
| 9 | 1 Scope 1.1 General 1.2 Inclusions 1.2.1 Emergency/trauma devices 1.2.2 Intraoperative retrieval devices 1.2.3 Postoperative devices 2 Normative references |
| 10 | 3 Definitions |
| 11 | 4 Requirements 4.1 Labeling requirements 4.1.1 Electromechanical device markings |
| 12 | 4.1.2 Disposable blood contact components 4.1.3 Operator’s manual/instructions for use |
| 13 | 4.1.4 Service manual 4.1.5 Collection container labeling 4.2 Performance requirements 4.2.1 System integrity 4.2.2 Cleanliness 4.2.3 Device anticoagulation |
| 14 | 4.2.4 Filtration 4.2.5 Interface characteristics 4.2.5.1 Material sterility 4.2.5.2 Component conformity 4.2.6 Material safety requirements 4.2.6.1 Toxicity 4.2.6.2 Pyrogenicity 4.2.7 Electrical safety 4.2.8 Electromagnetic compatibility 5 Tests |
| 15 | 5.1 Compliance with labeling requirements 5.1.1 Aspiration and reinfusion flow capacity (4.1.3 k1) 5.1.2 Storage capacities of the reservoir and processing and transfusion vessels (4.1.3 k2) 5.1.3 Processing (4.1.3 k3) 5.1.4 Free hemoglobin (4.1.3 k4) 5.1.5 Dwell time (4.1.3 k5) 5.1.6 WBC and platelet removal efficiencies (4.1.3 k6) |
| 16 | 5.1.7 Change in red blood cell concentrations (4.1.3 k7) 5.2 Compliance with performance requirements 5.2.1 System integrity |
| 17 | 5.2.2 Cleanliness 5.2.3 Device anticoagulation 5.2.4 Filtration |
| 18 | 5.2.5 Interface characteristics 5.2.5.1 Material sterility 5.2.5.2 Component conformity 5.2.6 Material safety requirements 5.2.6.1 Toxicity 5.2.6.2 Pyrogenicity 5.2.7 Electrical safety and 5.2.8 Electromagnetic compatibility |
| 19 | Annex A A.1 Scope A.1.1 Introduction |
| 20 | A.1.2 Need for the standard A.4 Rationale for the specific requirements of the standard A.4.1 Labeling requirements A.4.1.1 Electromechanical device markings A.4.1.2 Disposable blood contact components A.4.1.3 Operator’s manual/instructions for use |
| 21 | A.4.1.3 k) Minimal technical information A.4.1.3 k1) Aspiration and reinfusion flow capacities A.4.1.3 k2) Storage capacities of the reservoir and processing and transfusion vessels A.4.1.3 k3) Processing A.4.1.3 k4) Free hemoglobin A.4.1.3 k5) Dwell time A.4.1.3 k6) WBC and platelet removal efficiency |
| 22 | A.4.1.3 k7) Change in red blood cell concentrations A.4.1.3 n) Air embolization A.4.1.4 Service manual A.4.1.5 Collection container labeling A.4.2 Performance requirements A.4.2.1 System integrity A.4.2.2 Cleanliness |
| 23 | A.4.2.3 Device anticoagulation A.4.2.4 Filtration A.4.2.5 Interface characteristics A.4.2.5.1 Material sterility A.4.2.5.2 Component conformity A.4.2.6 Material safety requirements A.4.2.6.1 Toxicity A.4.2.6.2 Pyrogenicity A.4.2.7 Electrical safety |
| 24 | A.4.2.8 Electromagnetic compatibility |
| 25 | Bibliography |
