Contents
- 1. Reprocessors shall ensure that the personnel involved in t…
- 2. Reprocessors shall designate one or more persons responsib…
- 3. The person responsible for reprocessing shall comply with…
- 4. The premises where the reprocessing is taking place and th…
- 5. The surfaces of the premises, ambient air (temperature, hu…
- 6. The equipment shall be subject periodically to generally a…
- 7. The reprocessor shall describe in the technical documentat…
- 8. If the reprocessor decides that it has no longer the abili…
5.The surfaces of the premises, ambient air (temperature, humidity, viable and non-viable airborne particles), water and other gases and fluids shall be controlled and periodically monitored to verify that their microbiological and physical quality is adequate for reprocessing.
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