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I.S. EN 13795-3:2006

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 3: PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS

Available format(s)

Hardcopy , PDF

Superseded date

24-03-2011

Language(s)

English

Published date

01-01-2006

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.


Dates of withdrawal of national standards are available from NSAI.

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC on Medical Devices
Bibliography

Describes performance requirements for surgical drapes, gowns and clean air suits.

DevelopmentNote
2006 Edition Re-Issued in September 2009 & incorporates AMD 1 2009. (09/2009)
DocumentType
Standard
Pages
13
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

EN 13795-1:2002+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
EN ISO 22610:2006 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006)
ISO 22612:2005 Clothing for protection against infectious agents Test method for resistance to dry microbial penetration
ISO 22610:2006 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment Test method to determine the resistance to wet bacterial penetration
EN 13795-2:2004+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
EN ISO 22612:2005 Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005)

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