BS EN 13795-2-2019 pdf free download.Surgical clothing and drapes – Requirements and test methods Part 2: Clean air suits
This document specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing and processing requirements.
This document gives information on the characteristics of single-use and reusable clean air suits used as medical devices for clinical staff, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures.
This document specifies test methods for evaluating the identified characteristics of clean air suits and sets performance requirements for these products.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
EN 29073-3:1992, Textiles – Test methods for nonwovens – Part 3: Determination of tensile strength and elongation
EN ISO 139:2005, 1 Textiles — Standard atmospheres for conditioning and testing (ISO 139:2005 + Amd. 1:2011)
EN ISO 9073-10:2004, Textiles – Test methods for nonwovens – Part 10: Lint and other particles generation in the dry state (ISO 9073-10:2003)
EN ISO 10993-1:2009, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
EN ISO 11737-1:2018, Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
EN ISO 13938-1:1999, Textiles – Bursting properties of fabrics – Part 1: Hydraulic method for determination of bursting strength and bursting distension (ISO 13938-1:1999)
EN ISO 22612:2005, Clothing for protection against infectious agents – Test method for resistance to dry microbial penetration (ISO 22612:2005)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
4 Performance requirements
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.
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.
NOTE EN ISO 15797, though dealing with workwear and personal protective equipment (PPE), can be useful in developing standardized methods for reusable surgical textiles since it contains information on the principles and equipment for simulated industrial laundering.BS EN 13795-2 pdf download.