DIN EN ISO 10993-4:2007
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002+Amd.1:2006); German version EN ISO 10993-4:2002+A1:2006

Standard No.

DIN EN ISO 10993-4:2007

Release Date

2007

Published By

German Institute for Standardization

Status

Be replaced 2009-10

Replace By

DIN EN ISO 10993-4:2009

Latest

DIN EN ISO 10993-4/A1:2024-04

Scope

This part of ISO 10993 provides general requirements for evaluating the interactions of medica devices with blood. It describes a) a classcification 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 evalutaion of the interaction of devices with blood, c) the rationale for structured selectured selection of tests according to specific categories,together with the principles and scientific basis of these tests. Detailed requirements for testing can not be specified because of the limitations in knowledge and precision of tests for interactions of devices with blood.Futher, this part of ISO 10993 describes biological evaluation in general terms and may not nectssarily provide sufficient guidance for test methods for a specific device.The selection and design of test methods should take into consideration device design, materials,clinical utility,usage environment and risk benefit. This leves of specificity can only be covered in vertical standards.

DIN EN ISO 10993-4:2007 history

• 2024 DIN EN ISO 10993-4/A1:2024-04 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAM 1:2024); German and English version EN ISO 10993-4:2017/prA1:2024
• 2017 DIN EN ISO 10993-4:2017-12 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017
• 2017 DIN EN ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017
• 2009 DIN EN ISO 10993-4:2009 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006); English version of DIN EN ISO 10993-4:2009-10
• 2007 DIN EN ISO 10993-4:2007 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002+Amd.1:2006); German version EN ISO 10993-4:2002+A1:2006