Non-active surgical implants. Implants for osteosynthesis. Particular requirements

BS EN ISO 14602:2010 Non-active surgical implants. Implants for osteosynthesis. Particular requirements

BS EN ISO 14602 is an International Standard which specifies particular requirements for non-active surgical implants for osteosynthesis.

In addition to BS EN ISO 14630, BS EN ISO 14602 gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

Contents of BS EN ISO 14602:

Foreword

Introduction

1 Scope

2 Normative references

3 Terms and definitions

4 Intended performance

4.1 General

4.2 Intended purpose

4.3 Functional characteristics

4.4 Intended conditions of use

5 Design attributes

6 Materials

7 Design evaluation

7.1 General

7.2 Pre-clinical evaluation

7.3 Clinical evaluation

7.4 Post-market surveillance

8 Manufacturing

9 Sterilization

10 Packaging

11 Information supplied by manufacturer

11.1 General

11.2 Labelling

11.3 Instructions for use

11.4 Restrictions on combinations

11.5 Marking on implant

11.6 Marking for special purposes

Annex A (informative) Correspondence of the clauses of this International Standard to the fundamental principles outlined in ISO/TR 14283

Annex B (informative) ISO standards referring to implants and associated instruments found acceptable through clinical use for given applications in osteosynthesis

Annex C (informative) ISO Standards referring to materials found acceptable through proven clinical use

Annex D (informative) Standards related to testing and design evaluation

Bibliography