Standard EN 13795 consists of three separate parts :
- Characteristics of performance (part 1)
- Test methods (part 2)
- Performance thresholds (part 3).
EN 13795-1 (corresponding to the first part) gives general indications on the characteristics to be evaluated for each kind of product – surgical gowns, drapes, clean air suits – single-use or reusable product. It also gives details of the quality system relating to manufacturing and processing. This includes traceability processes and the validation of all steps of manufacturing and processing.
EN 13795-2 (corresponding to the second part) describes the test methods to be used to evaluate the characteristics described in EN 13795-1.
Each product shall be tested prior to being placed on the market, and in its sterile form (apart from the clean air suits).
See the test methods
EN 13795-3 (corresponding to the third part) defines the minimum standards for a product to meet the requirement of Directive 93/42/EEC and EN 13795.
These minimum values have been established by taking into account the conditions of surgical operations. In this way, they distinguish on the one hand, the products with a standard performance or high performance level, and on the other hand, the critical and less critical areas of a product.
Critical areas of a product are described as “product areas with the highest probability to be involved in the transfer of infective agents to the wound or the invasive area, or from the wound”, for instance: the front and sleeves of a surgical gown, the nearest area from the operative site.
The performance of a product will be addressed as “standard performance” or “high performance” depending on the duration, mechanical stress, biological or other liquids expected throughout the surgical procedure
Keep in mind ! To be classified "high performance" or "standard performance", a product shall meet all the minimum levels of required performance for all the required categories.
Order the entire text of the standard (EN 13795-1, EN 13795-2, EN 13795-3)
