BS EN ISO 14602:2011
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Non-active surgical implants. Implants for osteosynthesis. Particular requirements
Published By | Publication Date | Number of Pages |
BSI | 2011 | 26 |
ISO 14602:2010 specifies particular requirements for non-active surgical Implants for osteosynthesis, referred to as implants. In addition to ISO 14630, ISO 14602:2010 gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
PDF Catalog
PDF Pages | PDF Title |
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11 | Scope Normative references Terms and definitions Intended performance General |
12 | Intended purpose Functional characteristics |
13 | Intended conditions of use Design attributes |
14 | Materials Design evaluation General Pre-clinical evaluation Clinical evaluation Post-market surveillance |
15 | Manufacturing Sterilization Packaging Information supplied by manufacturer General Labelling Instructions for use Restrictions on combinations Marking on implant Marking for special purposes |