Name: DIN EN 13795-1 E : 2009
Brand: DIN

DIN EN 13795-1 E : 2009

Superseded

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Superseded date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

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

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 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.

DocumentType	Standard
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Superseded
SupersededBy	DIN EN 13795-1 E : 2019 DIN EN 13795-1:2019-06

Standards	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

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