Need help?

EN ISO 10993-4:2009 Standard

wave
Save  

  Keywords:

#part #principles #contact #use #intended

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)

  Purpose

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.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 10993-4:2002"

Anyway is still possible use the "EN ISO 10993-4:2002" until March 21st, 2010

  Related Standards

EN 455-4:2009

Medical devices Directive (93/42/EEC)

Medical gloves for single use - Part 4: Requirements and testing for shelf life determination

EN ISO 15883-4:2018

Medical devices Directive (93/42/EEC)

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endo...

EN 12470-4:2000+A1:2009

Medical devices Directive (93/42/EEC)

Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement

EN ISO 13408-2:2018

Medical devices Directive (93/42/EEC)

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

EN 13544-1:2007+A1:2009

Medical devices Directive (93/42/EEC)

Respiratory therapy equipment - Part 1: Nebulizing systems and their component

EN 13544-2:2002+A1:2009

Medical devices Directive (93/42/EEC)

Respiratory therapy equipment - Part 2: Tubing and connectors

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN ISO 10993-4:2009 STANDARD

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0