What is EN 13795: 2019?

In the year 2019, a major revolution was introduced in the field of Surgical equipment when EN 13795: 2019, a European standard for assessing the quality of surgical gowns, drapes as well as clean air suits, emerged in its refine form. It is important to underline here that this standardization consists of two parts. While the first part takes into account the fundamental requirement of test methods for surgical drapes as well as gowns, the other part principally puts light on clean air suits. These requirements are deemed to be extremely effective in controlling the cases of contamination that are likely to occur in case the prescribed guidelines are not followed vigilantly.

What has changed?

Although most of the guidelines remain the same, the documentation of the data has become more stringent now with the modifications introduced in EN Qualitative System. The results are now recorded in a well- defined average method rather than measuring just an abstract adherence to the prescribed regulation.   New section called “Treatment of Results” annexed to the existing module of EN has now made it possible for the surgeons to check the compliance of the surgical equipment with the required standards. All the results can be easily outlaid now without the possibility of any procrastination or neglect in the process. Moreover, it is interesting to see how different upper and lower quartile test have made it all the easier for medical companies like Surgeine healthcare to abide by the guidelines more concretely. Surgeine healthcare has been using these treatments of results for multiple evaluation procedures except wet microbial penetration.


How does Surgeine healthcare employ these guidelines in its working framework?


Surgeine healthcare has been active in the domain providing impeccable medical services to thousands of surgeons. Following the requirements necessitated by EN 13795: 2019 Surgeine employs the following steps-

Surgeine healthcare uses the tests such as dry microbial absorption and cleanliness of microbes in order to conduct the test of the upper half of the data. The way to evaluate the performance is to check if the upper quartile manages to meet the requirement established by EN 13795: 2019. Earlier, a medical Company like Surgeine healthcare would have to individually assess the CFU of surgical gowns which involved extensive testing and incubation and hence was a time-consuming process. With the introduction of EN 13795: 2019, the whole process has become transparent and more effortless.

Special Note-

It is important to underline here that most of the test methods as per EN 13795: 2019 have largely remain unchanged even after the revision of BS EN ISO 22610. The use of the standards established by 2006 are also quite useful in maintaining the overall credibility of the tests. With EN 13795:2019 takes into consideration the weaker spots too, it helps the surgeons in checking the gowns and drapes in a wholesome manner. It also eliminates the need to cross check the same equipment time and again. Moreover, since the instructions entailed in AAMI PB70 are also conjoined with those of EN 13795, an impeccable quality assurance can be ascertained. For all the health care workers as well as the patients, it is extremely important to have equipment free form any flaw in terms or wear or tear and EN 13795 proves to be very useful in this regard.

Why is Surgeine healthcare the most obvious choice of the medical fraternity?

Surgeine healthcare complies with all the prescribed tests diligently before it is recommended or implemented. We also try to ensure the complete safety and comfort of all the users. This regulated adherence to the guidelines makes all the documentation procedures easy and transparent. Since the instructions are provided to manufacturers, processors as well as distributors alike, Surgeine healthcare is able to give multidimensional security to all its buyers.

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