Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down r... (32020R1207)
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)
- 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)
- 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
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