PART ONE GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS EN 13795-1

Part One defines the general requirements for the design, processing, assessment and selection of products. The objective is to ensure the same level of safety from single-use and re-usable surgical clothing and drapes throughout their entire useful life.

PART TWO TEST METHODS EN 13795-2

Part Two of the standard describes the test methods to be used to evaluate the product characteristics indicated in Part One.

PART THREE PERFORMANCE REQUIREMENT AND PERFORMANCE LEVEL EN 13795-3

A Performance Requirements matrix divides covered products into standard performance and high performance classes. The matrix is then subdivided into critical and less critical product areas.

High performance products shall be used for surgical interventions with a high infection risk due to the length or intensity of the surgical intervention.

Critical product areas are defined as product areas that are more likely to be involved in the transfer of infectious agents to or from a wound, such as the front or sleeves of a surgical gown.

In the case of surgical gowns and drapes, labelling of products put on the market shall clearly indicate whether the product Is a standard or high performance level device.

The labelling shall further include the indication of critical and less critical product areas, as designed by the manufacturer.

The European Standard does not provide any recommendation for the end user as to which product shall be used for a specific surgical Intervention.

For this, the healthcare provider needs to perform a risk assessment for the surgical intervention in question and can request guidance for this from his provider of surgical gowns and drapes.

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