SS-EN-13795-2 Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits

SS-EN-13795-2 - 2019 EDITION - CURRENT
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This European Standard 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 European Standard 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 European Standard specifies test methods for evaluating the identified characteristics of clean air suits and sets performance requirements for these products.

To find similar documents by classification:

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

11.140 (Hospital equipment Including hospital beds, surgical tables, medical garments, medical gloves, containers for sharp disposal, etc.)


Medical devices. Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

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Designation Name

SS-EN 13795-2:2019

Revision Level

2019 EDITION

Status

Current

Publication Date

April 11, 2019

Language(s)

English

Page Count

40

International Equivalent

EN 13795-2:2019(IDT)