Name: EN 540 : 1993
Brand: CEN

EN 540 : 1993

Superseded

View Superseded by

CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS

Superseded date

01-02-2003

Published date

12-01-2013

Publisher

Comite Europeen de Normalisation

Cooperating organizations
National foreword
Foreword
0. Introduction
1. Scope
2. Normative references
3. Terminology and definitions
4. General requirements
5. Methodology
6. Presentation of results
Annex A (informative) Bibliography
National annex NA (informative) Committees responsible

Defines procedures to help manufacturers, regulatory authorities, sponsors and clinical investigators on the conduct and performance of the clinical investigation of medical devices. Also includes terminology and definitions.

Committee	CEN/TC 258
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Superseded
SupersededBy	EN ISO 14155-1:2009

Standards	Relationship
NBN EN 540 : 1993	Identical
NF EN 540 : 1993	Identical
NEN EN 540 : 1994	Identical
NS EN 540 : 1ED 1993	Identical
I.S. EN 540:1994	Identical
SN EN 540 : 1998	Identical
AS EN 540-2002	Identical
UNI EN 540 : 1995	Identical
UNE-EN 540:1994	Identical
BS EN 540:1993	Identical
DIN EN 540:1993-07	Identical

BS EN 724:1995	Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices
BS EN 12006-2 : 1998	NON-ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS
EN 12011 : 1998	INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
EN 13503-7 : 2001	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS
BS 7208-16(1998) : 1998	OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - GUIDANCE FOR CLINICAL INVESTIGATIONS
I.S. EN ISO 14727:1999	DENTAL IMPLANTS - PREFABRICATED PARTS CONNECTING SUPRASTRUCTURES TO DENTAL IMPLANTS - CONTENTS OF TECHNICAL FILE
01/564791 DC : DRAFT NOV 2001	BS EN 14299 - NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS
BS EN 50103:1996	Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry
BS EN 12523:1999	External limb prostheses and external orthoses. Requirements and test methods
I.S. EN 12006-2:1998	NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS
UNI EN 12006-2 : 2009	NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS
I.S. EN 12011:1998	INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
ISO 14727:1998	Dental implants Prefabricated parts connecting suprastructures to dental implants Contents of technical file
BS EN 12011:1998	Instrumentation to be used in association with non-active surgical implants. General requirements
BS EN ISO 14727:1999	Dental implants. Prefabricated parts connecting suprastructures to dental implants. Contents of technical file
EN ISO 14727:1998/AC:1998	DENTAL IMPLANTS - PREFABRICATED PARTS CONNECTING SUPRASTRUCTURES TO DENTAL IMPLANTS - CONTENTS OF TECHNICAL FILE
EN 12006-2:1998+A1:2009	Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits
DIN EN 12006-2:2009-08	NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS
BS EN 13503-7:2002	Ophthalmic implants. Intraocular lenses Clinical investigations
EN 12523 : 1999	EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS