INHALT

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