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ANSI/AAMI PB70:2022 (PB70) is a guidance document containing new and crucial information for the manufacturers and users of personal protective equipment (PPE) in the healthcare space. ANSI/AAMI PB70:2022, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, accounts for a decade of new knowledge and the evolution of technologies keep our frontline healthcare workers safe.

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PDF Pages	PDF Title
1	ANSI/AAMI PB70:2022; Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
3	Title page
4	AAMI Standard Copyright information
5	Contents
7	Committee representation
8	Acknowledgement
9	Foreword
10	Introduction
11	1 Scope 1.1 General 1.2 Inclusions 1.3 Exclusions
12	2 Normative references 3 Definitions
17	4 Requirements 4.1 Labeling requirements 4.1.1 Device labeling 4.1.2 Package labeling
18	4.1.3 Technical information 4.1.4 Education
19	4.2 Performance requirements 4.2.1 Barrier performance 4.2.1.1 General 4.2.1.2 Classification levels of barrier performance
20	4.2.1.3 Non-protective 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 4.2.3.2 Surgical gowns–E
21	4.2.3.3 Isolation gowns 4.2.3.4 Surgical drapes and drape accessories 4.2.3.5 Other gowns (e.g., procedure gown)
22	4.2.3.6 Decontamination gown 4.2.3.7 Hoods 4.2.3.8 Toga 4.2.3.9 Other protective apparel items (e.g., aprons, footwear covers, sleeves, protective headwear such as hats and caps) 5 Tests 5.1 Tests for the labeling requirements 5.2 Tests for the performance requirements
23	5.2.1 Barrier performance 5.2.1.1 Sampling 5.2.1.2 Barrier test methods for surgical gowns, isolation gowns, other gowns, other protective apparel, surgical drapes, and drape accessories
24	5.2.1.3 Non-protective products 5.2.1.4 Changes affecting barrier performance 5.2.2 Tracking mechanism for multiple-use products 5.2.3 Construction
25	Annex A (informative) 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
26	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
27	A.4.1.3 Technical information A.4.1.4 Education A.4.2 Rationale for the performance requirements A.4.2.1 Barrier performance
28	A.4.2.2 Tracking mechanism for multiple-use products A.4.2.3 Construction A.4.2.3.1 Surgical gowns A.4.2.3.2 Surgical gowns–E (a surgical gown with extended critical zones) A.4.2.3.3 Isolation gowns
29	A.4.2.3.4 Surgical drapes and drape accessories A.4.2.3.5 Other gowns (e.g., procedure gown, decontamination gown) A.4.2.3.6 Decontamination gowns A.4.2.3.7 Hoods A.4.2.3.8 Toga
30	A.4.2.3.9 Other protective apparel items (e.g., aprons, footwear covers, sleeves, protective headwear such as hats and caps) A.4.2.3.10 The sterile field and the critical zone
31	Annex B (informative) Examples of barrier performance classification of surgical gowns, surgical gowns-E, isolation gowns, other protective gowns, surgical drapes, hoods, togas, and other protective apparel
52	Annex C (informative) Example of a sampling plan
54	Annex D (informative) Rationale for changes to the 2012 edition of PB70
55	Bibliography

Published By	Publication Date	Number of Pages
AAMI	2022


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Standard Title	ANSI/AAMI PB70:2022, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
Published Code	AAMI
Publication Date	2022

AAMI PB70 2022

PDF Catalog

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