ISO 10993-4 PDF


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).

Author: Tojaktilar Gardataxe
Country: Togo
Language: English (Spanish)
Genre: Finance
Published (Last): 21 March 2011
Pages: 170
PDF File Size: 6.98 Mb
ePub File Size: 11.22 Mb
ISBN: 930-7-24920-941-5
Downloads: 74285
Price: Free* [*Free Regsitration Required]
Uploader: Mezigami

Hemocompatibility of blood contacting medical devices has to be evaluated before their intended application. 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].

Why should you use this standard?

Hemocompatibility testing

Find Similar Items This product falls into the following categories. Blood compatibility relates to specific interactions between bio materials and circulating blood.

Who is this standard for? Your basket is empty. Search all products by. 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. isk

Hemocompatibility testing (ISO )

The importance of fresh blood. These responses of blood are due to the natural response of the host defense mechanism against foreign surfaces. Please download Chrome or Firefox or view our browser tips. It is a specification stating general requirements for evaluating the interactions of medical devices with blood.

Click to learn more. In vitro hemocompatibility testing: Selection of tests for interactions with blood Status: To assess hemocompatibility, blood flow models are often used and can either consist of in vivo animal models or in vitro blood flow models. Worldwide Standards We can source any standard from anywhere in the world. You may experience issues viewing this site in Internet Explorer 9, 10 or References [1] van Oeveren W.


This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

BS EN ISO 10993-4:2017

We perform in vitro tests with fresh whole human blood to determine the hemocompatibility of materials, devices, or material structures using our unique blood circulating model Haemobile. This uso a more current description of in vitro techniques that rely less on the use of animals and generate more predictive results. Overview Product Details What is this standard about?

Learn more about the cookies we use and how to change your settings.

Medical equipment, Biological analysis and testing, Medical instruments, Medical technology, Blood, Blood coagulation, Haematology, Dental materials, Dental equipment, Biological hazards. Inadequate control by natural inhibitors results in pathological processes, such is microthrombi generation or thrombosis, bleeding complications, hemodynamic instability, fever, edema, and organ injury.

Accept and continue Learn more about the cookies we use and how to change your settings. In vitro blood flow model with physiological wall shear stress for hemocompatibility testing-An example of coronary stent testing. No blood-air interaction as is the case in the Chandler model. Pulsatile flow with physiological wall shear stress.

The standard is applicable to external communicating devices, either with an indirect blood path e.

Application of biomaterials in direct blood contact results in activation of the blood coagulation system and in an inflammatory reaction. Take the smart route to manage medical device compliance.


Use of fresh human blood within 30 minutes after blood withdrawal. We use cookies to make our website easier to use and to better understand your needs. You may find similar items within these categories by selecting from the choices kso.

We are specialized in assessing blood compatibility. Obstacles in haemocompatibility testing. Please feel free to contact us to see if we can be of assistance to your project.

Testing should be performed for five categories, based on primary processes: Stirred, shaken, or stagnant: Besides intrinsically driven research we perform basic contract research, which varies from simple hemolysis testing to custom build in vitro blood flow models. Io offer hemocompatibility testing in accordance with ISO What goes on at the blood-biomaterial interface.

Selection of tests for interactions with bloodcan be used as a directive to evaluate these hemocompatible characteristics. Moreover, sio have investigated the necessity of using fresh blood for hemocompatibilty testing is and have developed our own in vitro model for hemocompatibilty testing which utilizes pulsatile flow and physiological wall shear stress [4]. These adverse events can manifest themselves during prolonged and intensive foreign material contact, such as vascular implants and extracorporeal blood circulation.

The version was updated to match the current tools and techniques used to evaluate medical device blood material interactions.