Regulation 12

the equipment and materials used or intended to be used in the provision of the human tissue banking service are safe for such use; and

the equipment and materials are used in a manner that ensures the safe provision of the human tissue banking service.

each instrument and each equipment is installed, commissioned and used or operated properly, in accordance with the instructions of the manufacturer of the instrument or equipment;

every refrigerator or storage tank undergoes periodic maintenance to ensure the quality and usability of human tissue and reagents kept in the refrigerator or storage tank;

all refrigerators and storage tanks are used in a manner that —

prevents the mix-up, or contamination or cross‑contamination, of units of human tissue; and

ensures the safety and quality, and, where applicable, the viability and potency, of human tissue;

all instruments and other equipment, supplies and reagents used in the provision of the human tissue banking service are effective to ensure the safety and quality, and, where applicable, the viability and potency, of human tissue;

procedures are implemented for monitoring, inspecting and sterilising or cleaning each equipment used in the provision of the human tissue banking service;

appropriate tests and procedures are carried out periodically to ensure that any equipment or reagent used in the provision of the human tissue banking service complies with at least the tolerance limits determined by the manufacturer of the equipment or reagent;

the suppliers of any materials, the use of which is likely to have a material impact on the safety or quality, and, where applicable, the viability or potency, of human tissue, are selected and regularly evaluated to ensure that the materials obtained from the suppliers are safe and effective;

the following information about any supplies or reagent used in the collection, testing, processing and storage of human tissue by the licensee is identified and recorded:

the name of the supplies or reagent;

the name of the manufacturer;

the lot number;

the expiry date;

all sterilised instruments, supplies and reagents are clearly labelled to indicate the date on which the sterilisation took place;

procedures are implemented to monitor and maintain the conditions in which human tissue is stored, including the immediate notification of and response to temperature deviations outside acceptable ranges;

adequate, stable and appropriate electricity supply is provided for all laboratory equipment, including an adequate number of grounded electrical outlets and an emergency power supply for each piece of equipment that is essential for maintaining the safety and quality, and, where applicable, the viability and potency, of human tissue; and

procedures are implemented to ensure the safety of personnel using all facilities and equipment for the human tissue banking service.