EN 540 : 1993
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS
01-02-2003
12-01-2013
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Superseded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 |
| 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 |
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