Skip to main content

ISO 10993-4:2017

Current Date published:

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

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.

Get this standard Prices exclude GST
PDF ( Single user document)
$361.74 NZD
HardCopy
$406.09 NZD
Networkable PDF
Price varies
Preview only close
Prev {{ page }}/ {{ numPages }} Next
Preview only close
Prev {{ page }}/ {{ numPages }} Next
Pages: 69

Keep me up-to-date

Register to receive notifications when updates are made to this standard.

Related Information

Similar Standards

Preview only close
Prev {{ page }}/ {{ numPages }} Next
Preview only close
Prev {{ page }}/ {{ numPages }} Next
Pages: 69

ISO 10993-4:2017

Get this standard Prices exclude GST
PDF ( Single user document)
$361.74 NZD
HardCopy
$406.09 NZD
Networkable PDF
Price varies

Request to add this standard to your subscription

ISO 10993-4:2017

Price varies
Online library subscription

Click "Send request for subscription" to ask your Account Administrator to add this standard to your subscripiton.

Cancel