Standards Development

Scope

This document specifies requirements and test methods for materials and seams of re-usable and single use protective clothing providing protection of the wearer against infective biological agents. Design criteria, mechanical requirements, and functional fit requirements are based on either the ISO 16602 series or on ISO/DIS 20384 as indicated in this document, while the barrier properties of this document will be additive to ensure the protection against infective biological agents.

NOTE This standard is a standalone standard but using requirements based on ISO 16602 series and ISO/DIS 20384.

For products intended for the dual use as both a PPE and as a medical gown, both this document and the ISO/DIS 20384shall apply.

Clothing worn by surgical teams or drapes laid on patients to prevent cross-contamination during surgical interventions are not covered by the scope of this document, but are covered solely by ISO/DIS 20384.

This document is not applicable to components such as gloves, boots, eye/face protection devices and respiratory protective devices as their performance criteria are given in other standards. However, when these components are either an integral part of the protective clothing ensemble or are tested separately as partial body protection, supplementary requirements are provided in this standard. This document does not cover requirements for antimicrobial treatments for protective clothing.