BS EN 13795-2-2019 Surgical clothing and drapes – Requirements and test methods Part 2: Clean air suits.
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.
For testing processes, quantitative physical, chemical and/or biological tests are preferred.
5.3 A clinical evaluation for clean air suits shall be carried out and shall consider the performance of the clothing 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 The following 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.
6.1.2 The manufacturer shall inform the user of residual risks due to any shortcomings of the protection measures adopted.
6.1.3 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.
6.2 Information to be supplied to the processor
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.BS EN 13795-2 pdf download.