European Commission 19 August 2020, Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices (Text with EEA relevance)

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European Union · · · Cited by 27 · 20-08-2020

CHAPTER I. SUBJECT MATTER AND DEFINITIONS
Article 1. Subject matter
Article 2. Definitions
CHAPTER II. ORGANISATION OF REPROCESSING AND RISK MANAGEMENT
Article 3. Contracting external reprocessors
Article 4. Staff, premises and equipment
Article 5. Preliminary assessment of the suitability of a single-use device for reprocessing
Article 6. Original intended purpose and monitoring of changes made by the manufacturer of the original single-use device
Article 7. Determination of reprocessing cycle
Article 8. Maximum number of reprocessing cycles
Article 9. Technical documentation
CHAPTER III. PROCEDURES AND STEPS OF THE REPROCESSING CYCLE
Article 10. Establishment of procedures
Article 11. Steps of the reprocessing cycle
Article 12. Pre-treatment at the point of use and transportation
Article 13. Preparation before cleaning
Article 14. Cleaning
Article 15. Thermal disinfection
Article 16. Chemical disinfection
Article 17. Drying
Article 18. Inspection, maintenance, repair and functionality testing
Article 19. Packaging
Article 20. Labelling and provision of instructions for use
CHAPTER IV. QUALITY MANAGEMENT SYSTEM, ANNUAL AUDIT AND REPORTING OF INCIDENTS
Article 21. Quality management system
Article 22. Annual audit
Article 23. Reporting of incidents
CHAPTER V. TRACEABILITY OF SINGLE-USE DEVICE AND FINAL PROVISIONS
Article 24. Tracking of reprocessing cycles
Article 25. Records
Article 26. Entry into force and application

20.8.2020

Official Journal of the European Union

L 273/3

COMMISSION IMPLEMENTING REGULATION (EU) 2020/1207

of 19 August 2020

laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having

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