AAMI BF7 2012
$75.64
ANSI/AAMI BF7:2012 – Blood transfusion micro-filters
| Published By | Publication Date | Number of Pages |
| AAMI | 2012 | 29 |
This standard contains labeling requirements, performance requirements, test methods, and terminology for disposable blood transfusion microfilters for use with adult populations to remove microaggregates from blood or blood products during transfusion.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMIBF7:2012, Blood transfusion microfilters |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 8 | Committee representation |
| 9 | Foreword |
| 11 | 1 Scope 1.1 General 1.2 Inclusions 1.3 Exclusions 2 Normative references |
| 12 | 3 Definitions |
| 13 | 4 Requirements 4.1 Labeling 4.1.1 General 4.1.2 Primary package labeling 4.1.3 Instructions for use |
| 14 | 4.1.4 Disclosure information 4.2 Performance 4.2.1 Packaging 4.2.2 Filter device characteristics |
| 15 | 4.2.3 Device materials 4.2.4 Covers of the inflow and outflow connector portions 4.2.5 Structural integrity 4.2.5.1 Housing integrity 4.2.5.2 Media integrity 4.2.6 Filter performance 4.2.6.1 Filter cleanliness 4.2.6.2 Removal characteristics |
| 16 | 4.2.6.3 Volume capacity 4.2.6.4 Marking of direction of flow 4.3 Interface characteristics 4.3.1 Filters without attached administration sets 4.3.2 Filters with attached administration sets |
| 17 | 4.4 Material safety 4.4.1 Evaluation of potential toxicity 4.4.2 Sterility 4.4.3 Pyrogenicity 4.4.4 Compatibility with blood 4.4.5 Complement activation 4.4.6 Leachable substances 5 Tests 5.1 Labeling 5.1.1 Disclosure information |
| 18 | 5.2 Performance requirements 5.2.1 Packaging 5.2.2 Structural integrity 5.2.2.1 Housing integrity 5.2.2.2 Media integrity 5.2.3 Filter performance 5.2.3.1 Filter cleanliness |
| 19 | 5.2.3.2 Removal characteristics |
| 21 | 5.2.3.3 Volume capacity 5.3 Interface characteristics 5.3.1 Filters without attached administration sets |
| 22 | 5.3.2 Filters with attached administration sets 5.4 Material safety 5.4.1 Evaluation of potential toxicity 5.4.1.1 In vitro evaluation of components |
| 23 | 5.4.1.2 In vitro evaluation of the filter 5.4.1.3 In vivo evaluation of the filter |
| 24 | 5.4.2 Sterility 5.4.3 Pyrogenicity 5.4.4 Compatibility with blood |
| 25 | Annex A (informative) Rationale for the development and provisions of this standard A.1 Introduction A.2 Need for this standard A.3 Rationale for the specific provisions of this standard A.3.1 Labeling requirements A.3.1.1 General A.3.1.2 Primary package labeling A.3.1.3 Instructions for use |
| 26 | A.3.1.4 Disclosure information A.3.2 Performance requirements A.3.2.1 Packaging A.3.2.2 Structural integrity A.3.2.3 Filter performance |
| 27 | A.3.3 Interface characteristics A.3.3.1 Filters without attached administration sets A.3.3.2 Filters with attached administration sets |
| 28 | A.3.4 Material safety |
| 29 | Annex B Bibliography |
