Tissue establishments shall include in their standard operating procedures all processes that affect quality and safety and shall ensure that they are carried out under controlled conditions. Tissue establishments shall ensure that the equipment used, the working environment and process design, validation and control conditions are in compliance with the requirements referred to in Article 28(h).

Any modifications to the processes used in the preparation of tissues and cells shall also meet the criteria laid down in paragraph 1.

Tissue establishments shall include in their standard operating procedures special provisions for the handling of tissues and cells to be discarded, in order to prevent the contamination of other tissues or cells, the processing environment or personnel.