BS EN ISO 10993-4:2017 pdf free download.Biological evaluation of medical devices.The size of this pdf file is 60.3M.
BS EN ISO 10993-4:2017 specifies general requirements for evaluating the interactions of medical devices with blood.
It describes
a) a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1,
b) the fundamental principles governing the evaluation of the interaction of devices with blood,
c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.
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.
The selection and design of test methods for the interactions of medical devices with blood should take into consideration device design, materials, clinical utility, usage environment and risk benefit. This level of specificity can only be covered in vertical standards.
The initial source for develop oping this document was the publication, Guidelines for blood/material interactions,Report of the National Heart,Lung,and Blood Institute chapters9 and 10.This publication was subsequently revised.
5 Types of devices in contact with blood (as categorized in ISO 10993-1
5.1 Non-blood-contact devices
Non-blood-contact devices are devices that do not have direct or indirect contact with either blood or blood constituents that reside in the body or that are returned to the body. An in vitro diagnostic device and a blood-collection tube are examples of non-blood-contact devices Some devices, such as introducer systems for implants, may contain both blood-contacting and non-blood-contacting components.
5.2 External communicating devices
5.2.1 General
These are devices that contact the circulating blood and serve as a conduit into the vascular system Some devices may have components or portions with different types of contact (direct and indirect) xamples include but are not limited to the following.