< div class=" SectionLevel2" > < p class=" subsec1 cdone2" > < span class=" Head3 cdone" > 1.1< / span> & #x00a0 This specification and test methods cover the mechanical characterization of plates and screws for orthopedic internal fixation. Covered devices are fabricated from one or more hydrolytically degradable polymer (from this point on referred to as & #x201c absorbable& #x201d ) resins or resin composites.

< / div> < div class=" SectionLevel2" > < p class=" subsec1 cdone2" > < span class=" Head3 cdone" > 1.2< / span> & #x00a0 This specification establishes a common terminology to describe the size and other physical characteristics of absorbable implants and performance definitions related to the performance of absorbable devices.

< / div> < div class=" SectionLevel2" > < p class=" subsec1 cdone2" > < span class=" Head3 cdone" > 1.3< / span> & #x00a0 This specification establishes standard test methods to consistently measure performance-related mechanical characteristics of absorbable devices when tested under defined conditions of pretreatment, temperature, humidity, and testing machine speed.

< / div> < div class=" SectionLevel2" > < p class=" subsec1 cdone2" > < span class=" Head3 cdone" > 1.4< / span> & #x00a0 This specification may not be appropriate for all absorbable devices, especially those that possess limited hydrolytic susceptibility and degrade < span style=" font-style:italic font-weight:normal " class=" overriddenformat" > in vivo< / span> primarily through enzymatic action. The user is cautioned to consider the appropriateness of the standard in view of the particular absorbable device and its potential application.

< / div> < div class=" SectionLevel2" > < p class=" subsec1 cdone2" > < span class=" Head3 cdone" > 1.5< / span> & #x00a0 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

< / div> < div class=" SectionLevel2" > < p class=" caveat cdone2" > < span class=" Head3 cdone" > 1.6< / span> & #x00a0 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health and environmental practices and determine the applicability of regulatory limitations prior to use.

< / div> < div class=" SectionLevel2" > < p class=" WTOcaveat cdone2" > < span class=" Head3 cdone" > 1.7< / span> & #x00a0 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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