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Standards Development
This document specifies requirements for the characteristics and performance of single use and reusable surgical clothing (gowns in particular), drapes and equipment covers, where such products:
— Create a sterile field and minimize the transmission of infective agents during surgical and other invasive procedures.
— Are labelled with barrier performance claims
This document specifies the following concerning the manufacturing and processing of the products specified above:
— test methods for evaluating the characteristics as identified in this document,
— information to be supplied to users and third parties; notified bodies for instance,
For products intended for dual use as both a surgical product and as PPE, both this document and ISO 22615 shall apply.
Antimicrobial treated surgical clothing and drapes shall meet the requirements of this document. However, this document does not cover requirements for antimicrobial treatment of those products.
This document does not cover ancillaries such as gloves, boots, caps, absorbent towels, incision drapes. Necessary performance requirements for such ancillaries are specified in other standards.
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