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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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Superseded date

22-04-2019

Language(s)

English

Published date

01-01-2002

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Superseded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

ISO 13488:1996 Quality systems — Medical devices — Particular requirements for the application of ISO 9002
89/686/EEC : 1989 AMD 5 2012 COUNCIL DIRECTIVE OF 21 DECEMBER 1989 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO PERSONAL PROTECTIVE EQUIPMENT
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 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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