BS EN 13795-2:2019 pdf free.Surgical clothing and drapes -Requirements and test methods.
infective agent microorganism that has been shown to cause wound infections or that might cause infection in a member of the surgical team or the patient. manufacturer natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party Note 1 to entry: For more details refer to the Medical Device Directive 93/42/EEC. particle release release of fibre fragments and other particles during mechanical stress simulating handling and use.performance level discrete standard defined to classify products according to the performance requirements of this document Note 1 to entry: With the introduction of two performance levels this document acknowledges the fact that products are challenged to differing extents during surgical procedures, dependent upon the microbial cleanliness of the operating room required for the procedure.To comply with this document, products shall meet all the requirements specified in this document including Table 1, when tested according to Annex A of this document throughout their useful life. The biocompatibility of the product has to be evaluated and approved for acceptable risk in accordance with EN ISO 10993-1.  For general information on testing and details on the test methods given in this clause including Table 1 and their application for the purpose of this document, see Annex A. NOTE Information on characteristics, which cannot be properly evaluated or which are not regarded normative (as e.g. ‘comfort’) is given in Annexes B, D and E.The test methods given in Table 1 are materials tests. In order to manufacture a functioning clean air suit, design shall also be considered. When the material of the clean air suit is tight, bacteria are dispersed through the openings for head, arms and feet. Arm and feet openings shall therefore be closed. A barrier hood should be worn, tucked into the gap at the neckline (see Annex E, E.1). If the clean air suit consists of blouse and trousers, the blouse should be tucked into the trousers or designed with a tightly fitting waist.BS EN 13795-2 pdf download.