DIN EN 13795-1 E : 2009

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

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Superseded date: 01-06-2011

Language(s):

Published date: 12-01-2013

Publisher: German Institute for Standardisation (Deutsches Institut für Normung)

Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

Provides 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.

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Document Type	Standard
ISBN
Pages
Published
Publisher	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Superseded
Superseded By	DIN EN 13795-1 E : 2019 DIN EN 13795-1:2019-06

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
NF EN 13795-1 : 2003 + A1 2009	Identical
NEN EN 13795-1 : 2002 + A1 2009	Identical
UNI EN 13795-1 : 2009	Identical
NS EN 13795-1 : 2002 + A1 2009	Identical
BS EN 13795-1 : 2002	Identical
NBN EN 13795-1 : 2003 + A1 2009	Identical
SN EN 13795-1 : 2003 + A1 2009	Identical
UNE-EN 13795-1:2003	Identical
I.S. EN 13795-1:2002	Identical
EN 13795-1:2002+A1:2009	Identical

Standards Referencing This Book - (Show below) - (Hide below)

ISO 13488:1996	Quality systems — Medical devices — Particular requirements for the application of ISO 9002
EN 1174-3 : 1996	STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDE TO THE METHODS FOR VALIDATION OF MICROBIOLOGICAL TECHNIQUES
EN ISO 13488 : 2000	QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
EN 46001 : 1996	QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
EN ISO 9237 : 1995	TEXTILES - DETERMINATION OF PERMEABILITY OF FABRICS TO AIR
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
EN 724 : 1994	GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES
EN 1174-1 : 1996	STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS
EN 1041:2008+A1:2013	Information supplied by the manufacturer of medical devices
EN 1174-2 : 1996	STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDANCE
EN 14065:2016	Textiles - Laundry processed textiles - Biocontamination control system
EN ISO 11810:2015	Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Primary ignition, penetration, flame spread and secondary ignition (ISO 11810:2015)
ISO 11092:2014	Textiles — Physiological effects — Measurement of thermal and water-vapour resistance under steady-state conditions (sweating guarded-hotplate test)
EN 46002 : 1996	QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
EN 31092:1993/A1:2012	TEXTILES - DETERMINATION OF PHYSIOLOGICAL PROPERTIES - MEASUREMENT OF THERMAL AND WATER-VAPOUR RESISTANCE UNDER STEADY-STATE CONDITIONS (SWEATING GUARDED - HOTPLATE TEST) (ISO 11092:1993/AMD 1:2012)
EN 980:2008	Symbols for use in the labelling of medical devices

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