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Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants PAS 15 Test methods are given in

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Test methods are given in EN 12674-3 which are supported by performance levels in BS EN 12674-4

sleeve material of cover

with a quantification limit of 10 mg/kg total residue

it describes a simplified method for simulated in situ measurements of hearing aids and a description for determination of the directivity index (DI) of directional microphones in hearing aids in the horizontal plane

Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants PAS 15 Test methods are given in1. Scope 1. 1 The goal of this guide is to recommend a universal label format (across manufacturers and various implants) of content and relative location of information necessary for final implant selection within an implants overall package labeling.

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