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Biocompatibility Safety Assessment of Medical Devices: FDA/ISO

Biocompatibility Testing

IIRT is in India but is a renowned and trusted name for Biocompatibility testing in South Africa. Our Biocompatibility testing results are widely acknowledged and trusted. The sensitivity of testing is aware therefore, all the test is performed in the safe and secure environment considering all the necessary measures. We have a respectable and renowned clientele in South Africa. The process of biocompatibility testing in long and costly but we here, assures to give the accurate report in the promised time at the best possible price in the market.

Various safety evaluation studies are conducted on biomaterials, medical devices, and related products to identify the presence of toxins or any other harmful components. Biocompatibility testing needs to meet FDA and international standards and for that variety of test are done which ranges from the initial screening of new materials to product release testing, periodic audit testing, and non-clinical or pre-market safety evaluations.

Biomaterials, medical devices, and related products need a biocompatibility testing. The biocompatibility testing is done to challenge the different biological models with the suitable extract. The primary test categories to determine the biological effect includes: Acute systemic toxicity testing to identify if there is the presence of toxins or any other harmful effects. Biocompatibility testing starts with initial screening of new materials before a product release testing, periodic audit testing, and non-clinical or pre-market safety are the other evaluations which are done to meet the current FDA and international standards.

IIRT performs best biocompatibility testing to evaluate appropriate use of the component material or finished product. These biocompatibility tests challenge various biological models with the test material or a suitable extract. While biocompatible testing we assure to follow all the FDA guidance and ISO standards.

We are often asked about biocompatibility testing. The only reply we have is anything that medical instruments can have potential adverse effects from short-term (acute) to long-term (chronic) to the body. It is for this reason; medical devices are typically subject to biological evaluation and biocompatibility testing. The trust and the authentication of the medical equipment’s with biocompatibility testing make them more trusted and renowned.

Planning involves the collection of data of which the instrument is made up of. Since biocompatibility testing is to be done on animals therefore, we at IIRT assure that no unnecessary tests are conducted to ensure minimum exposure to test animals. During planning, it is also important to remember that Good Laboratory Practice (GLP) compliance is required for certain biocompatibility regulatory submissions. Therefore, we here assure to conduct biocompatibility testing according to GLP to allow for the maximum regulatory flexibility and compliance.

After materializing and planning the testing is done. The biocompatibility testing can be done based upon the device’s intended use. The biocompatibility testing of a device ranges from skin irritation testing to hemocompatibility and implantation testing.

Now one has to evaluate the data as per the first two procedures. Here, the intervention of an expert is recommended to interpret the data and test results. This will provide insight on the need of additional tests or whether the existing data provide enough information for an overall biological safety assessment of the device.

Biocompatibility testing are needed to see the potential toxicity ensuing from contact of the elements of medical devices. A wide vary of biocompatibility testing methodes to assist assess the risks of a replacement device style or process modification. Find out a lot of concerning our travel biocompatibility testing services these days.

Here, at Toxicity we perform the biocompatibility testing to evaluate the appropriate biocompatible use of the component material or finished product. These biocompatibility tests challenge the various biological models with the test material or a suitable extract. All the specific safety programs as per the guidelines of FDA are followed.

IIRT is a known and renowned institute for all kind of high grade medical testing. The biocompatibility testing is done in the best of the laboratory professionals who are well versed and experienced. The IIRT reports accuracy is widely accepted. We assure to use all the safety measures and follow all the three major steps which include planning, testing and evaluating the data.

Thus, here at IIRT we do the complete systematic biocompatibility study to assure the authentication of the result.

IIRT, undertake the Biocompatibility safety assesment of medical dvices as per ISO/FDA for following test/cotegories.

* Phys-chem studies

* Implantation Studies

* Irritation and Hypersensitivity

* Systemic Toxicity

* Cytotoxicity and Genotoxicity

* Immunotoxicity

* Toxicokinetics

Our team of expertise discuss with you the needs and after thorough understanding of the same advise the best testing plans that are the right choice of biocompatibility testing for your product.

The three common/general biocompatibility test that each device needs to go for includes:

Cytoxicity

Sensitization

Irritation test

It is after these tests and as per the presence of the toxic and leachable materials report, the further testing and services are advised. The Toxicity is a trusted and recognized name for biocompatibility testing. They assure that all the devices at Toxicity testing are compatible on human body.

 

BIOCOMPATIBILITY TESTING OF MEDICAL DEVICES (ISO 10993)

IIRT- Ghaziabad, UP, (India)

·         Accreditation with CPCSEA (Ministry of Environment & Forest), Government of India. 

·         Accreditation with ISO 9001:2008 (Provision of Industrial Research & Analysis Services)

·         Accreditation with OHSAS 18001:2007 (Provision of Industrial Research & Analysis Services)

·         OECD Principles of Good Laboratory Practices endorsed by European GLP Monitoring Authority (viz., UK)

·         Food safety & Drug Administration, Government of Uttar Pradesh

·         NABL (National Accreditation Board for Testing & Calibration Laboratories)

Biocompatibility Studies for Medical Devices under ISO 10993 and USP Plastics

Cytotoxicity

Implantation Testing

Genotoxicity

Irritation

Systemic Toxicity

ØAgar overlay

 

Ø  AMES test

Intracutaneous reactivity

Acute, Sub-acute and Pyrogen test

ØMEM Elution

Intramuscular (USP/ISO) and subcutaneous Implantation

Ø  Mouse lymphoma

Dermal Irritation

ØDirect contact

Ø  In vitro and In vivo micro nucleus

Ocular Irritation

Sub-chronic and Chronic

 

ØMTT assay

Ø  Chromosome Aberration

Mucosa Irritation

ØColony Formation

(Oral, Rectal, Vaginal, Penile)

Reproduction toxicity

 

Sensitization

Systemic Toxicity

Hemo-compatibility

USP Plastics

ØMaximization Test

ØAcute, Sub-acute and Pyrogen test

 

ØASTM Hemolysis tests – Direct and Indirect contact

ØUSP I-IV

ØClosed Patch (Buehler)

ØSystemic injection

ØLocal lymph node assay

ØSub-chronic and Chronic

ØIntracutaneous test

ØReproduction toxicity

ØImplant test

 

 

BIOCOMPATIBILITY TESTING OF MEDICAL DEVICES (ISO 10993)

Test Details and Sample Requirement

Category

Test Name

Surface area

Powder

Liquid

TAT

(Week)

G

Ml

Cytotoxicity

Agar Overlay

MEM Elution

Direct Contact

MTT Assay

Colony Formation

1 x 4 pieces

65 cm2

65 cm2

65 cm2

65 cm2

5

20

4

Sensitization

Murine LLNA Maximization Test Closed Patch Test

N/A

2 60 cm x 6 devices 2 1 in x 130 devices

16

24

60

30

60

80

5

7

8

Irritation

Intra-cutaneous Test Dermal Irritation Ocular Irritation Mucous membrane Irritation

60 cm x 2 devices 2 60 cm x 2 devices 2 60 cm x 2 devices Varies

8

 4

2

Varies

40

10

5

varies

5

5

5

Varies