BS/EN 13795-1-2019 pdf download.Surgical clothing and drapes – Requirements and test methods
Part 1: Surgical drapes and gowns.
A.1 General
A.1.1 Testing for evaluation of the performance of products shall be done according to the test methods specified in A.2. All test results and test conditions shall be recorded and retained.
A.1.2 Testing shall be performed on the finished product. If the product is to be used after sterilization, testing shall be performed on products after sterilization with the exception of microbial cleanliness. Testing shall include potential weak spots.
NOTE I Performance requirements can vary in relation to the areas the product and the risk of Involvement In the transfer of infective agents to or from the wound.
NOTE 2 To ensure product performance, combinations of materials or products in systems can be used.
NOTE 3 In particular, all types of joints in critical areas such as, e.g. seams in sleeves of surgical gowns, are regarded as potential weak spots.
A.1.3 During manufacture and processing, testing shall be conducted according to the requirements of the manufacturer’s and processor’s quality system.
A.1.4 Alternative test methods for monitoring may be used provided that they are validated and address the same characteristic and that the results have been shown to correlate with the test methods given in this document.
A.1.5 Where the test methods of this document do not specif’ the atmosphere for pre-conditioning, conditioning and testing, the specifications of EN ISO 139 shall be applied. Prior to testing, the samples shall be conditioned in the relaxed state.
A.2 Test methods and conformance
A.2.1 Test method for evaluation of cleanliness microbial/bioburden
For evaluation of cleanliness — microbial, the product shall be tested according to EN ISO 11737-1. NOTE EN ISO 11737-1 does not provide a fixed test method but specifies requirenlents for test methods and test mechanisms. The requirements of EN ISO 11737-1 are such that different test methods developed In accordance with It provide comparable results.
Five specimens shall be tested. The results shall be expressed as CFU/100 cm2. Report the individual results and determine Md and Uq (see A.3). Uq shall be equal to or less than the performance requirements in Tables I and 2.
As specified In EN ISO 9073-10, ten specimens, five for each side of the material, shall be tested. The
result of the test, i.e. the coefficient of linting, shall be calculated for particles in the size range 3 urn to
25 lam and reported as log10 of the count value. Report the individual results and determine Md and Uq
(see A.3). lJq shall be equal to or less than the performance requirements in Tables 1 and 2.
NOTE 2 Particles of this size range are considered to be capable of carrying microorganisms.
A.2.3 Test method for evaluation of liquid penetration
For evaluation of liquid penetration, the product shall be tested according to EN ISO 811.
The following specific amendments to the procedure in EN ISO 811 apply for the purpose of this document:
a) the test area shall be 100 cm2
b) the rate of increase of water pressure shall be (10 ± 0,5) cm/mEn;
c) the temperature of the water shall be (20 ± 2) °C;
d) the side of the product in contact with the test liquid shall be the outer side.
Five specimens shall be tested. Report the individual results and determine Md and Lq (see A.3). Lq shall be equal to or greater than the performance requirements in Tables 1 and 2.
As the test may be stopped once, the test limit hydrostatic pressure Is exceeded or the measurement capability of the instrument is exceeded, the value to be used in the median and lower quartile calculations for hydrostatic pressure testing shall be the lower of the breakthrough number or the upper measurement capability If this has been exceeded.
A.2.4 Test method for evaluation of bursting strength in dry and wet state
For evaluation of bursting strength, the product shall be tested according to EN ISO 13938- 1. The size of the test area shall be 10 cm2 (35.7 mm diameter). The preparation of samples for wet state testing shall be performed according to EN 29073-3.
The test conditions should be specified In the test report.
If there are differences in the test results of both sides of material, both sides should be tested and the results should be recorded.
Five specimens shall be tested. The pressure needed to break or compromise the barrier of the sample shall be reported. Report the individual results and determine Md and L1 (see A3). Lq shall be equal to or greater than the performance requirements in Tables I and 2.BS/EN 13795-1-2019 pdf download.

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