BS EN 13795-2:2019 pdf free

BS EN 13795-2:2019 pdf free.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 thy 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 thy 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.elcctropcdia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp.BS EN 13795-2 pdf download.