Singapore legislation

Regulation 2

of Healthcare Services (Human Tissue Banking Service) Regulations 2023

Regulation 2

Definitions

In these Regulations —“authorised person”, in relation to a deceased donor, means the person who may give all or any part of the body of the deceased donor under section 4 of the Medical (Therapy, Education and Research) Act 1972;“collect”, in relation to any human tissue, means to remove the human tissue from the body of a donor;“donor” means an individual, whether living or deceased, from whose body any human tissue is removed for the purposes of transplant or other clinical use;“General Regulations” means the Healthcare Services (General) Regulations 2021 (G.N. No. S 1035/2021);“incidental finding”, in relation to any examination or test on any human tissue collected from a donor, means any observation, result or other finding about the donor that is disclosed or discovered by or during the examination or test and has potential health or reproductive importance to the donor, but is not related to the purpose or objective of the examination or test;“licensee” means a person who holds a licence to provide a human tissue banking service;“living donor”, in relation to any human tissue, means a donor who is alive when the human tissue is removed from the donor;“personnel”, in relation to a licensee, means any individual employed or engaged by the licensee to assist the licensee in providing a human tissue banking service;“recipient”, in relation to any human tissue transplanted or used for the purpose of treating or preventing a human disease, means an individual to whose body the human tissue is transplanted or in whose body the human tissue is used;“transplant”, in relation to any human tissue, means —

(a)

to remove the human tissue from any part of the body of the donor; and

(b)

to transfer the human tissue to —

(i)

the donor’s body, whether it is the same part of the donor’s body from which the human tissue was removed or another part of the donor’s body; or

(ii)

the body of any other individual,whether or not the human tissue is processed, altered or manipulated after its removal from the donor’s body;“transplanting clinician”, in relation to any human tissue, means the medical practitioner who carries out the transplant of the human tissue;“transplanting licensee”, in relation to any human tissue, means a person who holds a licence to provide an acute hospital service or ambulatory surgical centre service and performs or intends to perform a transplant of the human tissue;“validated container”, in relation to the storage of any human tissue, means a container that is validated to store the human tissue in the conditions that will ensure that the human tissue will remain appropriate for its intended use.

Definition

“authorised person”, in relation to a deceased donor, means the person who may give all or any part of the body of the deceased donor under section 4 of the Medical (Therapy, Education and Research) Act 1972;

Definition

“collect”, in relation to any human tissue, means to remove the human tissue from the body of a donor;

Definition

“donor” means an individual, whether living or deceased, from whose body any human tissue is removed for the purposes of transplant or other clinical use;

Definition

“General Regulations” means the Healthcare Services (General) Regulations 2021 (G.N. No. S 1035/2021);

Definition

“incidental finding”, in relation to any examination or test on any human tissue collected from a donor, means any observation, result or other finding about the donor that is disclosed or discovered by or during the examination or test and has potential health or reproductive importance to the donor, but is not related to the purpose or objective of the examination or test;

Definition

“licensee” means a person who holds a licence to provide a human tissue banking service;

Definition

“living donor”, in relation to any human tissue, means a donor who is alive when the human tissue is removed from the donor;

Definition

“personnel”, in relation to a licensee, means any individual employed or engaged by the licensee to assist the licensee in providing a human tissue banking service;

Definition

“recipient”, in relation to any human tissue transplanted or used for the purpose of treating or preventing a human disease, means an individual to whose body the human tissue is transplanted or in whose body the human tissue is used;

Definition

“transplant”, in relation to any human tissue, means —

(a)

to remove the human tissue from any part of the body of the donor; and

(b)

to transfer the human tissue to —

(i)

the donor’s body, whether it is the same part of the donor’s body from which the human tissue was removed or another part of the donor’s body; or

(ii)

the body of any other individual,whether or not the human tissue is processed, altered or manipulated after its removal from the donor’s body;

Definition

“transplanting clinician”, in relation to any human tissue, means the medical practitioner who carries out the transplant of the human tissue;

Definition

“transplanting licensee”, in relation to any human tissue, means a person who holds a licence to provide an acute hospital service or ambulatory surgical centre service and performs or intends to perform a transplant of the human tissue;

Definition

“validated container”, in relation to the storage of any human tissue, means a container that is validated to store the human tissue in the conditions that will ensure that the human tissue will remain appropriate for its intended use.