Standard Swedish standard · SS-EN ISO 10993-4:2017

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)

Status: Valid

Buy this standard

Standard Swedish standard · SS-EN ISO 10993-4:2017

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
Subscribe on standards - Read more Dölj
Price: 1 731 SEK
standard ikon pdf

PDF

Price: 1 731 SEK
standard ikon

Paper

Price: 2 769,60 SEK
standard ikon pdf + standard ikon

PDF + paper

Show more Show less
Preview this standard
Scope
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.

Subjects

Biological evaluation of medical devices (11.100.20)


Buy this standard

Standard Swedish standard · SS-EN ISO 10993-4:2017

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
Subscribe on standards - Read more Dölj
Price: 1 731 SEK
standard ikon pdf

PDF

Price: 1 731 SEK
standard ikon

Paper

Price: 2 769,60 SEK
standard ikon pdf + standard ikon

PDF + paper

Show more Show less

Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-8029464

Edition: 4

Approved: 11/8/2017

No of pages: 92

Replaces: SS-EN ISO 10993-4:2017