AAMI BF64 2012
$75.64
ANSI/AAMI BF64:2012 – Leukocyte reduction filters
| Published By | Publication Date | Number of Pages |
| AAMI | 2012 | 21 |
This standard contains labeling requirements, performance requirements, test methods, and terminology for disposable filters used for the reduction of leukocytes from blood or blood components.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI BF64:2012, Leukocyte reduction filters |
| 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 1.3 Exclusions 2 Normative references |
| 10 | 3 Definitions 4 Requirements 4.1 Labeling requirements 4.1.1 General 4.1.2 Primary package labeling |
| 11 | 4.1.3 Instructions for use 4.1.4 Supporting information 4.1.4.1 Leukocyte reduction characteristics |
| 12 | 4.1.4.2 Cellular recovery 4.2 Performance requirements 4.2.1 Packaging 4.2.2 Filter device characteristics 4.2.3 Device materials |
| 13 | 4.2.4 Covers of the inflow and outflow connector portions 4.2.5 Structural integrity 4.2.6 Filter performance 4.2.6.1 Filter cleanliness 4.2.6.2 Reduction characteristics 4.2.6.3 Duration of filtration 4.2.6.3.1 Bedside filters 4.2.6.3.2 Prestorage filters |
| 14 | 4.3 Interface characteristics 4.3.1 Filters with attached administration sets 4.3.2 Dockable filters 4.4 Material safety 4.4.1 Evaluation of potential toxicity 4.4.2 Sterility 4.4.3 Pyrogenicity 5 Tests 5.1 Labeling 5.1.1 General 5.1.2 Primary package labeling 5.1.3 Instructions for use 5.1.4 Supporting information |
| 15 | 5.2 Performance 5.2.1 Packaging 5.2.2 Structural integrity 5.2.3 Filter performance 5.2.3.1 Filter cleanliness |
| 16 | 5.2.3.2 Reduction characteristics 5.2.3.3 Duration of filtration 5.3 Interface characteristics 5.3.1 Filters with attached administration sets |
| 17 | 5.4 Material safety 5.4.1 Evaluation of potential toxicity 5.4.2 Sterility 5.4.3 Pyrogenicity |
| 18 | Annex A Rationale for the development and provisions of this standard A.1 Introduction A.2 Need for this standard A.3 Definitions A.4 Rationale for the specific provisions of this standard A.4.1 Labeling requirements |
| 19 | A.4.2 Performance requirements |
| 20 | A.4.3 Interface characteristics A.4.4 Material safety |
| 21 | Annex B Bibliography |
