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99.60 Withdrawal effective Mar 16, 2011
CEN
CEN/TC 205 Non-active medical devices
European Norm
11.140 Hospital equipment
Withdrawn
This standard specifies information to be supplied to users and third party verifiers, in addition to the usual labelling of medical devices (see EN 980 and EN 1041), concerning manufacturing and processing requirements. This standard gives general guidance on the characteristics of single-use and reusable surgical gowns, surgical drapes and clean air suits used as medical devices for patients, clinical staff and equipment. It is intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures.
Surgical masks, surgical gloves, packaging materials, foot and head wear and incision drapes are not covered by EN 13795. Requirements for medical gloves are given in the EN 455 series of European Standards and packaging materials are covered by the EN 868 series. Requirements for surgical masks and head coverings will be specified in future CEN/TC 205 standards.
EN 13795 does not cover requirements for flammability of products used in laser surgery. Suitable test methods for flammability and resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810. Additional essential requirements that apply to surgical clothing and drapes are covered by other European Standards.
Legislation related to this standard
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
WITHDRAWN
EN 13795-1:2002+A1:2009
99.60
Withdrawal effective
Mar 16, 2011
WITHDRAWN
EN 13795:2011