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giovedì, luglio 08, 2004

ISO: risk management ISO/TR 22869 - dispositivi ISO 18112 e ISO/CD 14971- anticoagulati ISO 17953


WG1 recommended a title change, revised scope, and CD vote for a new proposal on risk management. Approved in May 2004, the proposal is being developed as a Technical Report, Medical laboratories – Reduction of error through risk management and continual improvement. ISO/TC 212 agreed with the recommendation and approved advancement of the document. In addition, the document, known as ISO/TR 22869, was approved for distribution and vote.

At the meeting of ISO/TC 212/WG3, significant progress was made in the development of a new work item, ISO 18112: Clinical laboratory testing and in vitro diagnostic test systems – In vitro diagnostic medical devices – Information supplied by the manufacturer. ISO/TC 212 approved the development of ISO 18112 in five parts which include: Part 1- General requirements; Part 2- Reagents for professional use; Part 3 – Instruments for professional use; Part 4 – Reagents for self-testing; and Part 5 – Instruments for self-testing. In addition, ISO/TC 212 approved ISO 17953, Clinical laboratory testing and in vitro diagnostic test systems — Requirements for in vitro monitoring systems for self-testing of oral anticoagulation therapy, for distribution and vote as a DIS with the inclusion of an informational annex.

ISO/TC 210/JWG1 and ISO/TC 212/WG3 held a meeting to address comments and complete ISO/CD 14971, Annex H – Guidance on risk analysis for in vitro diagnostic medical devices. The working groups have worked diligently to meet established timelines. Once approved, the annex will become part of ISO 14971, and further revision will be the responsibility of TC 210/JWG1, with participation and concurrence by representatives of TC 212/WG3.

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