ISO 22610:2018 Surgical Drapes, Gowns and Clean Air Suits, used as Medical Devices, for Patients, Clinical Staff and Equipment

Surgical Drapes, Gowns And Clean Air Suits, Used As Medical Devices, For Patients, Clinical Staff And Equipment

This document specifies a test method, with associated test apparatus, which is used to determine the resistance of a material to the penetration of bacteria, carried by a liquid, when subjected to mechanical rubbing.

Introduction

There are numerous examples of situations where bacteria carried by a liquid may migrate through a barrier material in the wet state.

European medical device regulations specifically place the responsibility for avoiding device-related infections on the manufacturer. In order to demonstrate compliance with this requirement and to describe a product to the user, there is a need to use harmonized and recognized international test methods.

The test method described in this international standard uses microbiological techniques and is therefore intended to be performed exclusively by laboratories experienced in and equipped for such work.

The primary difference between this document and ISO 22610:2006 is that this document specifies a strain of a different bacterial species and tighter tolerances on material handling and procedure, resulting in more reproducible and accurate measurements.

In order to obtain accurate repeatable and reproducible results, not only does the equipment need to meet the requirements specified in this document, but also the material handling and test procedure need to be followed precisely and consistently. Minor deviations from the equipment requirements, procedure and/or specimen handling can result in considerable loss of repeatability, reproducibility and accuracy of the measurement.

WARNING The use of this document may involve hazardous materials, operations and equipment. This document does not purport to address all of the safety problems associated with its use. It is the responsibility of the user of this document to establish appropriate safety and health practices prior to the application of this document and to comply with the legal requirements for this purpose.

IMPORTANT This test method has been technically and editorially significantly revised. The equipment shall meet the requirements specified in this document and the measurements shall be carried out under the specified conditions with special attention being paid to specimen (pre) treatment, strictly following the procedure prescribed in this document. Minor deviations from the equipment requirements, procedure and/or specimen handling can result in considerable loss of repeatability, reproducibility and accuracy of the measurement.