Rechercher

1.1 This Standard specifies general requirements related to the safety of human cells, tissues, and organs used for transplantation, and includes quality system requirements. It includes aspects of safety for potential and actual donors and recipients, personnel, and others who might be exposed to or affected by the transplantation of cells, tissues, or organs. 1.2 This Standard applies to…

1.1 This Standard addresses issues related to the safety of human tissues used for transplantation. It includes quality system requirements and aspects of safety for potential and actual donors and recipients, personnel, and others who could be exposed to, or affected by, the transplant of tissues. 1.2 This Standard applies to establishments and individuals involved in the following activities…

1.1 This Standard addresses issues related to the safety of human perfusable organs used for transplantation. It includes quality system requirements and aspects of safety for potential and actual donors and recipients, personnel, and others who might be exposed to, or affected by, the transplantation of perfusable organs. 1.2 This Standard applies to establishments (or facilities) and…

1.1 This Standard addresses issues related to the safety of human ocular tissues used for transplantation purposes. It includes aspects of safety for potential and actual donors and recipients, personnel, and others who might be exposed to or affected by the transplant of ocular tissues. 1.2 This Standard applies to eye banks and other establishments and to individuals involved in the…

1.1 This Standard addresses issues related to the safety of human allogeneic and autologous cells of lymphohematopoietic origin used for transplantation and includes quality system requirements. This Standard includes aspects of safety for potential and actual donors and recipients, personnel, and others who might be exposed to or affected by the transplant of lymphohematopoietic cells. The…

1.1 This Standard is intended to form the basis of a QMS within a health care or home setting for the purpose of providing safe, reliable kidney dialysis treatments. Note: A comprehensive QMS can be achieved when this Standard is used in combination with the following related Standards: a) CAN/CSA-C22.2 No. 60601-1; b) CAN/CSA-C22.2 No. 60601-2-16; c) CAN/CSA-C22.2 No. 60601-2-39; d)…

ISO 10393:2013 provides practical guidance to suppliers on consumer product recalls and other corrective actions after the product has left the manufacturing facility. Other corrective actions include, but are not limited to, refunds, retrofit, repair, replacement, disposal and public notification. ISO 10393:2013 is intended to apply to consumer products, but might also be applicable to other…

Scope 1.1 This Standard is intended to form the basis of a QMS within a health care setting for the purpose of providing safe, reliable reprocessing of reusable medical devices and is designed to be used with the CSA Z314 series of Standards addressing specific aspects of medical device reprocessing. A comprehensive QMS can be achieved when this Standard is used in combination with related…

ISO/TS 22002-2:2013 specifies the requirements for the design, implementation, and maintenance of prerequisite programmes (PRPs) to assist in controlling food safety hazards in catering. ISO/TS 22002-2:2013 is applicable to all organizations which are involved in the processing, preparation, distribution, transport, and serving of food and meals and wish to implement PRPs in accordance with the…

1 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…