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BS EN 13795-1 : 2002

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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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

Language(s)

English

Published date

01-01-2002

Superseded date

22-04-2019

€152.15
Excluding VAT
Summarise this standard

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 infection in the
                        operating theatre
Annex ZA (informative) - Relationship between this European
                         Standard and the Essential
                         Requirements of EU Directive
                         93/42/EEC on Medical Devices
Bibliography

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

Committee
CH/205/1
DevelopmentNote
Supersedes 99/566848 DC (12/2002) 2002 Edition Re-Issued in August 2009 & incorporates AMD 1 2009. (08/2009)
DocumentType
Standard
Pages
18
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

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A newer version of this standard is available.

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€152.15
Excluding VAT