Publication date : Life cycle Previously Withdrawn. Final text received or FDIS registered for formal approval. Proof sent to secretariat or FDIS ballot initiated: 8 weeks. Close of voting. Proof returned by secretariat. Got a question? Customer care. Keep up to date with ISO Sign up to our newsletter for the latest news, views and product information.
Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.
The changes in this document do not indicate that testing conducted according to prior versions of this document is invalid. For marketed devices with a history of safe clinical use, additional testing according to this revision is not recommended.
Proof returned by secretariat 60 Publication Check out our FAQs. Buy this standard. Abstract Preview ISO specifies general requirements for evaluating the interactions of medical devices with blood. Status : Published. Publication date : This standard contributes to the following Sustainable Development Goal :. CHF Buy.
0コメント