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NS EN 13795-1 : 2002 + A1 2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Superseded date

06-01-2011

Published date

01-12-2013

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.

DevelopmentNote
2002 Edition Re-Issued in October 2009 & incorporates AMD 1 2009. (11/2009)
DocumentType
Standard
PublisherName
Norwegian Standards (Norges Standardiseringsforbund)
Status
Superseded

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