Singapore legislation

Regulation 18

of Healthcare Services (Human Tissue Banking Service) Regulations 2023

Regulation 18

Collection of human tissue

Subregulation 1

A licensee must, in relation to the collection of human tissue —

(a)

develop and implement appropriate protocols for the safe and proper collection of human tissue to ensure the retention of the biological functions compatible with the intended use of the human tissue;

(b)

ensure that each individual who collects human tissue for or on behalf of the licensee is trained and competent in the protocols mentioned in sub‑paragraph (a);

(c)

provide all equipment and materials necessary for the safe and proper collection of the human tissue to ensure the retention of biological functions compatible with the intended use of the human tissue; and

(d)

ensure that the donor is not subject to any procedure or test that is unnecessary for the purpose of collecting the human tissue.

Subregulation 2

Where the human tissue is collected from a deceased donor, the licensee must keep and maintain records of —

(a)

the time of cooling or refrigeration of the body of the deceased donor; and

(b)

the time of cardiac death.