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

Importancia y uso:

5.1 The quality and consequently the clinical performance of implants may be affected by residues. Residues may induce no tissue response, minor tissue irritations, or they may lead to local inflammation of tissues surrounding the implant which may lead to failure in short-term or long-term use. Residues may also cause harm at locations away from the implant. Residues may originate from manufacturing materials used in the course of processing or from the manufacturing environment, or may be the result of handling and packaging (1-3).10

5.2 This practice shall be used to report the results of testing for residue. All residues cannot necessarily be detected. It suggests standard techniques that may be applied for analysis, and provides suggestions for how limit values may be set.

5.3 Residues may be of inorganic, organic, or biological nature. They may exhibit as surface-bound substance, or as adsorbates (for example, electrostatically held), efflorescence, or mechanically held substances. Residues may be soluble in aqueous media, soluble in organic solvents, or may be insoluble particulates.

5.4 Data generated in validation processes (that is, cleaning validation or sterility validation) may be used as results or as basis for setting acceptance criteria in the report.

Subcomité:

F04.15

Referida por:

F3127-22, D8179-18R24, F3335-20, E3418-23E01

Volúmen:

13.02

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

analysis; cleanliness; contamination; limit value; residues;