ANSI/AAMI PB70:2012 pdf download.Liquid barrier performance and dlassification of protective apparel and drapes intended for use in health care facilities.
This standard establishes minimum barrier performance requirements, a classification system, and associated
labeling requirements for protective apparel, surgical drapes, and drape accessories intended for use in health care facilities.
1.2 Inclusions
This standard covers surgical drapes, drape accessories, and all types of protective apparel that are labeled with
liquid barrier claims or liquidborne microbial barrier claims (e.g-, single-use and multiple-use surgical gowns, decontamination garments, isolation gowns, aprons, sleeve protectors, laboratory attire, and other garments) and that are regulated by the U.S. Food and Drug Administration (FDA) as medical devices under 21 CFR 878.
NOTE 1- -Surgical apparel is casfed by the FDA under 21 CFR 878.4040, and surgical drapes and drape accessories are
classified under 21 CFR 878. 4370.
NOTE 2- For additional information regarding the scope of this standard, see Annex A, A.1.1 and A.1.2. Other informative annexes are also induded in this standard.
1.3 Exclusions
This standard does not cover the following:
a) protective apparel for the hands, such as surgical gloves, patient examination gloves, and other medical gloves;
b) protective apparel for the head, face, and eyes, such as goggles, face shields, surgical caps or hoods, surgical masks, and respirators;
c) protective apparel for the feet, such as operating room shoes, shoe covers, and surgical boots;
d) other types of protective clothing worm by health care personnel, such as (1) apparel that is not intended or labeled as a barrier to liquid or microorganisms (e.g, surgical scrubs, cover coats) and (2) apparel or equipment that is used when handling hazardous chemicals, chemotherapeutic agents, or hazardous wastes;
e) absorbent operating room (OR) towels;
f) all of the requirements necessary to ensure the safety and effectiveness of the products within the scope of this standard;
g) the interfaces between products, such as the gown/glove interface;
h) all of the labeling or other information that a health care facility might deem necessary or desirable in product selection;
i) protection from dry particulate and dry microbial penetration;
j) manufacturing, quality assurance, or purchasing specifications;ANSI/AAMI PB70 pdf download.