Chapter II ORGANISATION OF REPROCESSING AND RISK MANAGEMENT
United Kingdom
- 3Contracting external reprocessors
- 4Staff, premises and equipment
- 5Preliminary assessment of the suitability of a single-use device for reprocessing
- 6Original intended purpose and monitoring of changes made by the manufacturer of the original single-use device
- 7Determination of reprocessing cycle
- 8Maximum number of reprocessing cycles
- 9Technical documentation