AAMI PB70 2012 RL
$112.60
ANSI/AAMI PB70:2012 Red-Line – Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
| Published By | Publication Date | Number of Pages |
| AAMI | 2012 | 76 |
This standard establishes a system of classification for protective apparel and drapes used in health care facilities based on their liquid barrier performance and specifies related labeling requirements and standardized test methods for determining compliance. By specifying a consistent basis for testing and labeling protective apparel and drapes and providing a common understanding of barrier properties (e.g., efficacy against liquid or liquidborneliquid-borne microorganism penetration) based on this new classification system, the standard is intended to ultimately assist end-users in determining the typestype(s) of protective product most appropriate for a particular task or situation.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI PB70:2012 – RED-LINE ANSI/AAMI PB70:2012, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
| 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 |
| 8 | Committee representation |
| 9 | Acknowledgments |
| 10 | Foreword |
| 11 | 1 Scope 1.1 General 1.2 Inclusions 1.3 Exclusions |
| 12 | 2 Normative references 3 Definitions |
| 14 | 4 Requirements 4.1 Labeling requirements 4.1.1 Device labeling |
| 15 | 4.1.2 Package labeling 4.1.3 Technical information 4.1.4 Education 4.2 Performance requirements 4.2.1 Barrier performance 4.2.1.1 General 4.2.1.2 Classification levels of barrier performance |
| 16 | 4.2.1.3 Nonprotective products 4.2.1.4 Changes affecting barrier performance |
| 17 | 4.2.2 Tracking mechanism for multiple-use products 4.2.3 Construction 4.2.3.1 Surgical gowns, isolation gowns and other protective apparel 4.2.3.2 Surgical drapes and drape accessories 5 Tests 5.1 Tests for the labeling requirements 5.2 Tests for the performance requirements 5.2.1 Barrier performance 5.2.1.1 Sampling |
| 18 | 5.2.1.2 Barrier test methods for surgical gowns, isolation gowns, other protective apparel, surgical drapes, and drape accessories 5.2.1.3 Nonprotective products 5.2.1.4 Changes affecting barrier performance 5.2.2 Tracking mechanism for multiple-use products |
| 19 | 5.2.3 Construction |
| 20 | Annex A (informative) Rationale for the development and provisions of this standard |
| 25 | Annex B (informative) Examples of barrier performance classification of surgical gowns, isolation gowns, other protective apparel, and surgical drapes |
| 30 | Annex C (informative) Examples of sampling plans |
| 33 | Annex D (informative) Bibliography D.1 Cited references |
| 34 | D.2 Other references |
| 37 | Annex E (informative) Rationale for changes to the 2003 edition of PB70 |
| 39 | ANSI/AAMI PB70:2012 ANSI/AAMI PB70:2012, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
| 40 | Objectives and uses of AAMI standards and recommended practices |
| 41 | Title page |
| 42 | AAMI Standard Copyright information |
| 43 | Contents |
| 45 | Glossary of equivalent standards |
| 47 | Committee representation |
| 48 | Acknowledgments |
| 49 | Foreword |
| 51 | 1 Scope 1.1 General 1.2 Inclusions 1.3 Exclusions |
| 52 | 2 Normative references 3 Definitions |
| 54 | 4 Requirements 4.1 Labeling requirements 4.1.1 Device labeling |
| 55 | 4.1.2 Package labeling 4.1.3 Technical information 4.1.4 Education 4.2 Performance requirements 4.2.1 Barrier performance 4.2.1.1 General |
| 56 | 4.2.1.2 Classification levels of barrier performance |
| 57 | 4.2.1.3 Nonprotective products 4.2.1.4 Changes affecting barrier performance 4.2.2 Tracking mechanism for multiple-use products 4.2.3 Construction 4.2.3.1 Surgical gowns, isolation gowns and other protective apparel 4.2.3.2 Surgical drapes and drape accessories 5 Tests 5.1 Tests for the labeling requirements 5.2 Tests for the performance requirements |
| 58 | 5.2.1 Barrier performance 5.2.1.1 Sampling 5.2.1.2 Barrier test methods for surgical gowns, isolation gowns, other protective apparel, surgical drapes, and drape accessories |
| 59 | 5.2.1.3 Nonprotective products 5.2.1.4 Changes affecting barrier performance 5.2.2 Tracking mechanism for multiple-use products 5.2.3 Construction |
| 60 | Annex A, Rationale for the development and provisions of this standard A.1 Need for the standard, history of development, and scope A.1.1 Need for the standard and history of development A.1.2 Scope of the standard |
| 61 | A.2 Normative references A.3 Definitions A.4 Requirements A.4.1 Rationale for the labeling requirements A.4.1.1 Device labeling A.4.1.2 Package labeling A.4.1.3 Technical information A.4.1.4 Education |
| 62 | A.4.2 Rationale for the performance requirements A.4.2.1 Barrier performance A.4.2.2 Tracking mechanism for multiple-use products A.4.2.3 Construction A.4.2.3.1 Surgical gowns, isolation gowns and other protective apparel |
| 63 | A.4.2.3.2 Surgical drapes and drape accessories A.4.2.3.3 The sterile field and the critical zone |
| 65 | Annex B, Examples of barrier performance classification of surgical gowns, isolation gowns, other protective apparel, and surgical drapes |
| 70 | Annex C, Examples of sampling plans |
| 72 | Annex D, Bibliography D.1 Cited references |
| 73 | D.2 Other references |
| 76 | Annex E, Rationale for changes to the 2009 edition of PB70 |
