BS EN 13795-1:2019 pdf download.Surgical clothing and drapes – Requirements and test methods Part 1: Surgical drapes and gowns.
4 Performance requirements To comply with this document, products shall meet all the requirements specified in this document including Tables 1 or 2 (as appropriate to the product), when tested according to AnnexA of this document throughout their useful life. The biocompatibility of the product shall be evaluated and approved for acceptable risk. If the manufacturer does not differentiate product areas, all areas shall meet the requirements for critical product areas. If the intended purpose of a medical device specifies the use as a sterile field the requirements for surgical drapes and equipment covers apply as per Table 2. For general information on testing and details on the test methods given in this clause including Tables 1 and 2 and their application for the purpose of this document, see Annex A. NOTE 1 Performance requirements are specified depending on product area and performance level. However, for some characteristics the performance requirement will apply for all performance levels and product areas of the medical device. NOTE 2 Information on characteristics, which cannot be properly evaluated (as ‘adhesion for fixation for the purpose of wound isolation’ or liquid control’) or which are not regarded normative (as ‘comfort’) is given in Annex C.
5 Manufacturing and processing requirements and documentation 5.1 The manufacturer and processor shall document that the requirements of this document are met and that the fitness for the intended purpose has been established for each use, both for single-use and reusable medical devices. 5.2 The manufacturer/processor shall establish, document, implement and maintain a formal quality management system, which includes risk management and maintain its effectiveness. This quality management system shall include requirements throughout product realization, including development, design, manufacture, testing, packaging, labelling, distribution and, for reusable products, processing and life-cycle control. Inputs for product realization shall include the outputs from risk management. A quality system such as EN ISO 13485 is recommended, in case of processing of reusable products applied in accordance with EN 14065. Packaging for terminally sterilized medical devices is recommended according to EN ISO 11607 series of standards. For testing processes, quantitative physical, chemical and/ or biological tests are preferred. 5.3 A clinical evaluation for surgical drapes and gowns shall be carried out and shall consider the performance of the full draping and gowning system to establish fitness for purpose. The evaluation shall include the critical review of the applicable clinical literature and the results of post market surveillance and vigilance.BS EN 13795-1 pdf download.