Standard Swedish standard · SS-EN 13795-1+A1:2009

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products

Status: Withdrawn

· Replaced by: SS-EN 13795:2011
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Standard Swedish standard · SS-EN 13795-1+A1:2009

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products
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Scope
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.

Subjects

Hospital equipment (11.140)


Buy this standard

Standard Swedish standard · SS-EN 13795-1+A1:2009

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products
Subscribe on standards - Read more Dölj
Price: 793 SEK
standard ikon pdf

PDF

Price: 793 SEK
standard ikon

Paper

Show more Show less

Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-70401

Edition: 1

Approved: 7/23/2009

No of pages: 24

Replaces: SS-EN 13795-1

Replaced by: SS-EN 13795:2011