09/30180393 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
31-07-2010
English
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 Reference to previous generation(s) or similar
devices
4.7 Risk assessment
4.8 Control of infection and microbial contamination
4.9 Biological evaluation
4.10 Clinical evaluation
4.11 Manufacturing process
4.12 Quality control of the implant manufacturing process
4.13 Packaging
4.13.1 Primary container
4.13.2 Protection from damage in storage and transport
4.14 Label
4.15 Instructions for use
Bibliography
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