BS EN 13795-1 pdf free download
BS EN 13795-1 pdf free download. Surgical clothing and drapes – Requirements and test methods.
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 Annex A of this document throughout their useful life.
The biocompatibility of the product shall be evaluated and approved for acceptable risk
lithe manufacturer does not differentiate product areas, all areas shall meet the requirements for critical product areas.
lithe 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.
6 Information to be supplied with the product
6.1 Information to be supplied to the user
6.1.1 In addition to the information to be supplied according to the Medical Device Directive
93/42/EEC, if the manufacturer or processor differentiates between critical and less critical areas of the product, he/she shall supply information to identify them.
6.1.2 The following additional information shall be supplied on request:
a) the identity or information on the test methods used;
b) the results of testing and test conditions for the characteristics given in Clause 4.
6.1.3 The manufacturer shall inform the user of residual risks due to any shortcomings of the protection measures adopted.
6.1.4 The manufacturer shall provide sufficient information about intended use of the product or product system when conducting a surgical procedure. This shall include information on the performance level of the product.
6.1.5 The manufacturer shall provide information on the flammability of the product and fire risks in relation with it on request.
6.2 Information to be supplied to the processor
6.2.1 For reusable products the manufacturer shall obtain information to be supplied to the processor on the number of reuses based on standardized processes, together with information on measures for maintaining the technical and functional safety of the medical device and packaging.
6.2.2 For products to be terminally sterilized, the manufacturer shall supply instructions for the sterilization processes to be applied.BS EN 13795-1 pdf download.
