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Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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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

Available format(s): Hardcopy, PDF

Superseded date: 22-04-2019

Language(s): English

Published date: 01-01-2002

Publisher: British Standards Institution

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 information to be supplied to users and third party verifiers, in addition to the usual labelling of medical devices, concerning manufacturing and processing requirements.

General Product Information - (Show below) - (Hide below)

Committee	CH/205/1
Development Note	Supersedes 99/566848 DC (12/2002) 2002 Edition Re-Issued in August 2009 & incorporates AMD 1 2009. (08/2009)
Document Type	Standard
ISBN
Pages
Published
Publisher	British Standards Institution
Status	Superseded
Superseded By	BS EN 13795-1:2019 BS EN 13795:2011+A1:2013
Supersedes	99/566848 DC : JAN 2000

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

Equivalent Standard(s)	Relationship
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
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
DIN EN 13795-1 E : 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
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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