Buy EN ISO Biological Evaluation Of Medical Devices – Part 4: Selection Of Tests For Interactions With Blood (Iso ) from SAI Global. Guidelines for such evaluations are subsequently presented in ISO , ” Selection of Tests for Interactions with Blood.” This standard provides a structured . Partie 4: Choix des essais pour les interactions avec le sang. STANDARD. ISO. Third edition. Reference number. ISO (E).

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We are specialized in assessing blood compatibility. Testing should be performed for five categories, based on primary processes: You may experience issues viewing this site in Internet Explorer 9, 10 or Obstacles in haemocompatibility testing. Worldwide Standards We can source any standard from anywhere in the world.

What goes on at the blood-biomaterial interface. Use of fresh human blood within 30 minutes after blood withdrawal. To assess hemocompatibility, blood flow models are often used and can either consist of in vivo animal models or in vitro blood flow models.

Medical equipment, Biological analysis and testing, Medical instruments, Medical technology, Blood, Blood coagulation, Haematology, Dental materials, Dental equipment, Biological hazards.

Hemocompatibility testing (ISO )

Accept and continue Learn more about the cookies we use and how to change your settings. Pulsatile flow with physiological wall shear stress. Selection of tests for interactions with blood Status: Inadequate control by natural inhibitors results in pathological processes, such as microthrombi generation or thrombosis, bleeding complications, hemodynamic instability, fever, edema, and organ injury. Learn more about the cookies we use and how to change your settings. Find Similar Items This product falls into the following categories.


The version was updated to match the current tools and techniques used to evaluate medical device blood material interactions. The model has a low background for thrombosis.

We offer hemocompatibility testing in accordance with ISO Your basket is empty. We have developed our own in vitro blood flow model [4] which offers several important advantages: Search all products by. It is a specification stating general requirements for evaluating the interactions of medical devices with blood.

As one of our experts, Dr Wim van Oeveren, is a member of the ISO committee that drafts and revises the ISO standard, we are very well qualified to help you perform hemocompatibility testing to achieve CE or FDA certification regarding blood compatibility.

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Hemocompatibility testing

Given the disadvantages of animal models, such as higher costs, more variability, more time consuming, and insensitivity due to overwhelming short-term effects of tissue injury, in vitro blood flow models are more attractive.

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Who is this standard for? Stirred, shaken, or stagnant: No blood-air interaction as is the case in the Chandler model. Basic research Still having a strong connection with academia, HaemoScan is committed to advancing the Isso interface research and hemocompatibility testing.


Selection of tests for interactions with bloodcan be used as a directive to evaluate these hemocompatible characteristics. Test laboratories and medical devices manufacturers.

Why should you use this standard?

These responses of blood are due to the natural response of the host defense mechanism against foreign surfaces. Biological evaluation of medical devices—Part 4: In this system all relevant aspects of blood activation are taken into consideration, but, and this is most important, testing should simulate clinical conditions as much as possible.

Moreover, we have investigated the necessity of using fresh blood for hemocompatibilty testing [3] and have developed our own in vitro model for hemocompatibilty testing which utilizes pulsatile flow and physiological wall shear stress [4]. In vitro blood flow model with physiological wall shear stress for hemocompatibility testing-An example of coronary stent testing.

Blood compatibility relates to specific interactions between bio materials and circulating blood. In recent years it has done so by reviewing literature and identifying the obstacles of hemocompatibility testing [1] and by describing the state-of-the-art blood—biomaterial interface research [2]. Please download Chrome or Firefox or view our browser tips. In vitro hemocompatibility testing: