RS ARS 1695-1
Medical devices — Surgical gowns, drapes and clean air suits — Part 1: General requirements


This African Standard specifies information to be supplied to users and third-party verifiers, in addition to
the usual labelling of medical devices as stipulated in ISO 15223-1, concerning manufacturing and
processing requirements. This standard gives general guidance on the characteristics of single-use and
reusable surgical gowns, surgical drapes and clean air suits used as medical devices for patients, clinical
staff and equipment. It is intended to prevent the transmission of infective agents between patients and
clinical staff during surgical and other invasive procedures. This standard does not include the
requirements for incision drapes.

General Information

RS ARS 1695-1AFRICAN STANDARDSHealth care technology18First Edition
Nov 2021
Price: RWF 7,500

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