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IMPLANTS FOR SURGERY - CLEANLINESS OF ORTHOPEDIC IMPLANTS - GENERAL REQUIREMENTS
Publisher: International Organization for Standardization
Published: 01-01-2018
Available Formats: PDF - English, Hardcopy - English, PDF - French, Hardcopy - French More Info on product formats
ForewordIntroduction1 Scope2 Normative references3 Terms and definitions4 General requirements5 Cleanliness evaluation - Test methods and cleanliness acceptance criteria after final cleaning6 Continued process verification7 DocumentationAnnex A (informative) - Potential sources of harm in a cleaning processAnnex B (informative) - Relation between cleaning process design, validation and risk managementAnnex C (informative) - Relation between cleaning validation, biological evaluation and sterilization validationBibliography
This document specifies requirements for the cleanliness of orthopaedic implants, hereafter referred to as implants, and test methods for the cleaning process validation and controls, which are based on a risk management process.
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