ISO 10993-4 AMD 1 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood AMENDMENT 1

	Purchase Information Use this form to request purchase information on ISO online subscriptions. ISO Collections First Name: Last Name: Email address:

Document ISO 10993-4 AMD 1 is offered by IHS as part of an online subscription. This subscription contains many documents on the same topic.

You may also purchase this document alone from the IHS Standards Store.

ISO 10993-4 AMD 1 Document Information:

Title
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood AMENDMENT 1

International Organization for Standardization

Publication Date:
Jul 15, 2006

Scope:

This part of ISO 10993 provides general requirements for evaluating the interactions of medical devices with blood.

It describes

a) a classification of medical and dental 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 interactions of devices with blood. This part of ISO 10993 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.

About IHS
IHS (NYSE: IHS) is a leading global provider of critical technical information, decision-support tools and related services in a number of industries including aerospace and defense, automotive, construction, electronics, and energy. IHS serves customers ranging from large governments and multinational corporations to smaller companies and technical professionals in more than 100 countries. IHS been in business for more than 45 years and employ more than 2,300 people around the world.