Customer Support: 131 242

  • There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert

UNE-EN 13795-1:2003

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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

Available format(s)

Hardcopy , PDF

Withdrawn date

22-03-2010

Language(s)

Spanish, Castilian

Published date

13-06-2003

Foreword
Introduction
1 Scope
2 Terms and definitions
3 Information to be supplied by the manufacturer or
  processor
4 Manufacturing and processing requirements
5 Testing requirements
Annex A (informative) Comfort
Annex B (informative) Adhesion for fixation and wound
        isolation
Annex C (informative) Prevention of indication in the
        operating theatre
Annex ZA (informative) Clauses of this European Standard
         addressing essential requirements or other
         provisions of EU Directives
Bibliography

Provides information that to be supplied to users and third party verifiers, in addition to the usual labelling of medical devices, concerning manufacturing and processing requirements. It also 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.

Committee
CTN 111
DevelopmentNote
2003 Edition Re-Issued in January 2010 & incorporates AMD 1 2010. (01/2010)
DocumentType
Standard
Pages
18
PublisherName
Asociacion Espanola de Normalizacion
Status
Withdrawn
SupersededBy

View more information
$107.67
Including GST where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Need help?
Call us on 131 242, then click here to start a Screen Sharing session
so we can help right away! Learn more