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SFS-EN 13795-2:2019:en

Surgical clothing and drapes. Requirements and test methods. Part 2: Clean air suits

Publication can be downloaded immediately Publication will be delivered the day after the order is submitted Delivery time 3 - 5 working days
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Scope
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.

The standards writing body responsible for this document in Finland is General Industry Federation.
Product group(s)
11.140 Hospital equipment »
Relationships
Normative references
EN 29073-3:1992 Textiles - Test methods for nonwovens - Part 3: Determination of tensile strength and elongation
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 health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
Technical committee
CEN/TC 205 Non-active medical devices »
Directive
93/42/EEC Medical devices
2007/47/EC 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

http://ec.europa.eu »
Date of implementation
12.04.2019
Published
16.04.2019
Edition
1
Pages
29
Language(s)
English

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