BS EN 13795-1:2019 pdf free.Surgical clothing and drapes -Requirements and test methods.
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 duration, mechanical stress and liquid challenge throughout the surgical procedure. standard performance classification addressing minimum performance requirements for various characteristics of products used as medical devices in invasive surgical procedures high performance classification addressing elevated performance requirements for various characteristics of products used as medical devices in invasive surgical procedures Note 1 to entry: Examples of surgical procedures where elevated performance level should be considered are those where extensive exposure to liquid, mechanical stresses or longer surgical procedures can be expected. processor natural or legal person who processes products so that their performance complies with the requirements of this document  Note 1 to entry: A processor who places a product on the market is a manufacturer in the sense of this document. Note 2 to entry: A processor of reusable products is often referred to as a ‘reprocessor’ and processing reusable products is often referred to as ‘reprocessing’ (as e.g. in Medical Device Directive 93/42/EEC]. References in EN 13795-2 and this document to ‘processors’ include ‘reprocessors’ and to ‘processing’ include ‘reprocessing’. product surgical gown, surgical drape including equipment covering Note 1 to entry:  In cases of surgical packs, each gown or drape is regarded as a product.BS EN 13795-1 pdf download.