Tissues for assisted reproduction

Scope

1.1
This Standard addresses issues related to the safety of donated tissues used for third party assisted reproduction. It includes quality system requirements and aspects of safety for the potential and actual donors and recipients, any children born as a result of an assisted reproduction procedure, personnel, and others who may be exposed to or affected by the use of reproductive tissues. This Standard is intended to serve as a benchmark and provide minimum requirements for the verification of safe practices in the donor suitability assessment, retrieval, processing, preservation, packaging, labelling, storage, quarantine, evaluation, recordkeeping, adverse event reporting, distribution, importation or exportation, and recall of tissues for assisted reproduction.

1.2
This Standard applies to establishments and individuals involved in the following activities related to tissues for assisted reproduction:
(a) processing;
(b) evaluation of the safety of reproductive tissues prior to use;
(c) assisted reproduction procedures;
(d) recordkeeping;
(e) distribution;
(f) importation or exportation;
(g) error, accident, and adverse reaction reporting; and
(h) complaints and recalls.

1.3
This Standard is intended to serve as a benchmark and provide minimum requirements for the verification of safe practices in each of the activities listed in Items (a) through (h) in Clause 1.2.
Note: Examples of establishments or individuals include the following:
(a) tissue retrieval organizations;
(b) sperm banks;
(c) fertility clinics;
(d) centres for assisted reproduction;
(e) processing facilities;
(f) cell culture laboratories;
(g) health care professionals;
(h) designated importers and exporters; and
(i) distributors.

1.4
This Standard is not intended to replace detailed specifications and standard operating procedures but is intended to be used in their preparation.

1.5
The requirements in this Standard apply only to reproductive tissues intended for use by third parties (i.e., recipients who are not the donor's spouse, common law partner, or sexual partner).

1.6
The safety of all donated tissues used for assisted reproduction in Canada, wherever procured, is the responsibility of the reproductive tissue processors and designated importers.

1.7
In this Standard, "shall" is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; "should" is used to express a recommendation or that which is advised but not required; and "may" is used to express an option or that which is permissible within the limits of the standard.

Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material.

Notes to tables and figures are considered part of the table or figure and may be written as requirements.

Annexes are designated normative (mandatory) or informative (nonmandatory) to define their application