BS EN 13795-1:2019 pdf free
BS EN 13795-1:2019 pdf free.Surgical clothing and drapes – Requirements and test methods Part 1: Surgical drapes and gowns.
This document specifies infonnation 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 surgical gowns and surgical drapes used as medical devices for patients, clinical staff and equipment, 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 surgical drapes and gowns and sets performance requirements for these products.
This document does not cover requirements for resistance to penetration by laser radiation of products. Suitable test methods for resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810.
This document does not cover requirements for incision drapes or films.
This document does not cover requirements for antimicrobial treatments for surgical gowns and drapes. Antimicrobial treatment can cause environmental risks such as resistance and pollution. However, antimicrobial treated surgical gowns and drapes fall under the scope of this document with respect to their use as surgical gowns and drapes.
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.
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:JJwww.electropedia.org/
• ISO Online browsing platform: available at http:J/www.iso.orglobp
3.1 colony forming unit CFU unit by which the culturable number of microorganisms is expressed
Note Ito entry: The culturable number is the number of microorganisms, single cells or aggregates, able to form colonies on a solid nutrient medium.
3.2 cleanliness freedom from unwanted foreign matter
Note 1 to entry: Such matter can be microorganisms, organic residues or particulate matter.
3.2.1 cleanliness — microbial freedom from population of viable micro-organisms on a product and/or a package
Note I to entry: In practical use, microbial cleanliness is often referred to as ‘bioburden’.
3.3 critical product area product area with a greater probability to be involved in the transfer of infective agents to or from the wound, e.g. front and sleeves of surgical gowns.BS EN 13795-1 pdf download.
