Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Cleanliness evaluation - Test methods and
  cleanliness acceptance criteria after final cleaning
6 Continued process verification
7 Documentation
Annex A (informative) - Potential sources of harm
        in a cleaning process
Annex B (informative) - Relation between cleaning
        process design, validation and risk management
Annex C (informative) - Relation between cleaning
        validation, biological evaluation and
        sterilization validation
Bibliography

Abstract

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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 150