Contents Foreword 1 Scope 2 Normative references 3 Terms and definitions 4 Requirements 5 Testing methods 6 Inspection rules 7 Use instructions 8 Marks of implants 9 Packaging and label 10 Transport and storage 11 Usage requirements Annex A (Informative) Acceptable implants for osteosynthesis proved by clinical usage and relevant device standards Annex B (Informative) ISO standards for acceptable materials proved by clinical usage Annex C (Informative) ISO standards and industrial standards regarding design evaluation and test Annex D (Informative) ASTM standards regarding design evaluation and test
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