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

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, BSI

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Description

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.

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PDF Pages	PDF Title
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

Additional information

Status	Under Review
Pages	26
Publication Date	2011-10-31
ISBN	978 0 580 76946 7
Standard Number	BS EN ISO 14602:2011
Title	Non-active surgical implants. Implants for osteosynthesis. Particular requirements
Identical National Standard Of	EN ISO 14602:2011
Replaces	BS EN ISO 14602:2010
Descriptors	Surgical equipment, Performance, Instructions for use, Implants (surgical), Performance testing, Design, Orthopaedics, Medical equipment, Orthopaedic equipment
Publisher	BSI
Committee	CH/150/5
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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BS EN ISO 14602:2011

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