Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments

Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments

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1.   Scope

The purpose of this practice is to describe how the cleanliness of single-use implants as manufactured shall be reported. This practice proposes how to approach the identification of critical compounds and suggests different analytical methods.