NEN EN ISO 10451 : 2010
Current
The latest, up-to-date edition.
DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 General
4.2 Intended use
4.3 Design characteristics
4.4 Properties of the constituent materials
4.5 Properties of the final product
4.6 Manufacturing process
4.7 Quality control of the implant manufacturing
process
4.8 Control of infection and microbial contamination
4.9 Risk assessment
4.10 Clinical evaluation
4.11 Packaging
4.12 Label
4.13 Instructions for use
Bibliography
Defines requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for a dental implant and any prefabricated part thereof which remains in the mouth after surgery.
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Current
|
| Standards | Relationship |
| UNI EN ISO 10451 : 2010 | Identical |
| UNE-EN ISO 10451:2010 | Identical |
| DIN EN ISO 10451:2010-11 | Identical |
| BS EN ISO 10451:2010 | Identical |
| ISO 10451:2010 | Identical |
| SN EN ISO 10451 : 2010 | Identical |
| I.S. EN ISO 10451:2010 | Identical |
| EN ISO 10451:2010 | Identical |
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