scope:

General

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.

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 classified 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 important information regarding the scope of this standard, see Annex A, A.1.1 and A.1.2. Other informative annexes are also included in this standard.

Exclusions

This standard does not cover

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 worn 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;

k) criteria for evaluating experimental products; or

l) guidance for properly handling, processing, or preparing products for reuse in health care facilities.

NOTE-For guidelines on the processing of multiple-use surgical textile products, refer to ANSI/AAMI ST65, Processing of reusable surgical textiles for use in health care facilities.