Name: UNI EN 13795-1 : 2009
Brand: UNI

UNI EN 13795-1 : 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Superseded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Superseded date

08-06-2022

Published date

01-01-2009

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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

Describes information to be supplied to users and third party verifiers, in addition to the usual labeling of medical devices, concerning manufacturing and processing requirements. Also 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	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN 13795-1 : 2019 UNI EN 13795 : 2011 UNI EN 13795 : 2013
Supersedes	UNI EN 13795-1 : 2004

Standards	Relationship
NF EN 13795-1 : 2003 + A1 2009	Identical
NEN EN 13795-1 : 2002 + A1 2009	Identical
NS EN 13795-1 : 2002 + A1 2009	Identical
BS EN 13795-1 : 2002	Identical
DIN EN 13795-1:2009-10	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
DIN EN 13795-1 E : 2009	Identical

EN 455-1:2000	MEDICAL GLOVES FOR SINGLE USE - PART 1: REQUIREMENTS AND TESTING FOR FREEDOM FROM HOLES
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 868-5:2009	Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
EN 868-4:2017	Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
EN ISO 9237 : 1995	TEXTILES - DETERMINATION OF PERMEABILITY OF FABRICS TO AIR
EN 455-4:2009	Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
EN 868-1 : 1997	PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
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 868-6:2017	Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
EN 455-3:2015	Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
EN 868-2:2017	Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
EN 868-3:2017	Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
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 455-2:2015	Medical gloves for single use - Part 2: Requirements and testing for physical properties
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
EN 868-7:2017	Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods