With Hospital-Acquired Infections (HAI) affecting many patients at high cost to the healthcare system, it is vital to ensure that surgical drapes and gowns offer the best possible barrier protection.
How do we ensure this?
EN 13795 is the European standards relating to general requirements, testing methods and specific performance levels for single-use and multiple-use surgical drapes, gowns and clean air suits. The standard is designed to ensure that a basic level of performance has been achieved in order for a surgical gown or drape to be classed as fit to use for a surgery.
EN 13795 consists of three parts:
Part 1: General requirements for manufacturers, processors and products
• The scope includes testing requirements as follows:
Part 2: Test methods
• This section stipulates the test methods that manufacturers or processors will have to complete in order to ensure that the device will comply with the requirements in parts 1 and 3 of the standard.
Part 3: Performance requirements and performance levels
• The levels of performance are selected as ‘standard ’or ‘high performance ’and are differentiated by critical and less critical areas on drapes or gowns.
• Standard Performance addresses the minimum performance requirements of medical devices, while High Performance addresses elevated performance requirements. These differ according to levels of mechanical stress, fluid levels and durations of surgical procedures.
How is EN13795 relevant in choosing a theatre textile?
This European standard lists uniform testing methods enabling you to compare material performances from the testing report and make an informative pre-selection of the available fabrics.
To arrange a consultation with PrionTex call the Cape Town office on 021 797 1878, Johannesburg on 011 237 5900 or visit www.priontex.com for more information.
- REUSABLE surgical drapes and gowns
- SINGLE-USE surgical drapes and gowns
- CUSTOMISED operating packs
- Theatre attire
- Decontamination suits
- Theatre linen outsource service
