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1 Scope 1.1 General 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.…

1 Scope 1.1 Standard addresses This Standard is intended to address the safe, effective, and reliable reprocessing of reusable medical devices at each phase of the reprocessing workflow, including a) establishing a QMS for the MDRA, including i) key performance indicators; ii) policies and procedures; iii) documentation; iv) roles and responsibilities; v) management review; vi) planning…

1 Scope 1.1 Purpose This Standard specifies general requirements related to the safety of human CTOs 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 CTOs. 1.2 Areas of application This Standard applies to…

1 Scope 1.1 Purpose 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 Areas of application This Standard applies to…

1 Scope 1.1 Purpose 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…

1 Scope 1.1 Purpose 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 Inclusions This Standard applies to establishments and individuals involved…

1 Scope 1.1 Purpose 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 Inclusions This Standard applies to eye banks and other establishments and to…

This document defines minimum data sets for implants to facilitate recording and international exchange of data for the purposes of implant tracking systems. This data can also be used to support retrieval analysis and implant registry. This document is applicable to the manufacturers and distributors of medical devices intended for implant via a surgical procedure and to those hospitals and…

1.1 This Standard is intended to address the safe, effective, and reliable reprocessing of reusable medical devices at each phase of the reprocessing workflow, including a) establishing a QMS for the MDRD, including i) key performance indicators; ii) policies and procedures; iii) documentation; iv) roles and responsibilities; v) management review; vi) planning, resources and operations…

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 potential and actual donors and recipients, any children born as a result of an assisted reproduction procedure, personnel, and others who might be exposed to or affected by the use of reproductive tissues. This…