Konmex Sp. z o.o. of Jozefow at MEDICA 2020 in Düsseldorf -- MEDICA - World Forum for Medicine
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Konmex Sp. z o.o.

Naklowskiej 5, 05-410 Jozefow
Poland

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Contact

Dr. Damian Matak

Test site managment

Phone
+48 22 7800632

Email
d.matak@konmex.com

Dr. Łukasz Szymański

Chemical Study Director

Phone
+48 22 7800632

Email
l.szymanski@konmex.com

Kamila Gołaszewska

In Vitro Study Director

Phone
+48 22 7800632

Email
k.golaszewska@konmex.com

DVM Anna Wiatrowska

In Vivo Study Director

Phone
+48 22 7800632

Email
a.wiatrowska@konmex.com

Visit us

Unsettled / NN

16.11.2020

Topic

all-day

ISO 10993 biocompatiblity testing - How we do it?

We will answer all of your questions about biocompatiblity testing of your produtcs and:
  • Biological Evaluation Plan (BEP)
  • Biological Evaluation Report (BER)
  • Risk analysis
  • Clinical evaluation
  • Instruction for Use

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14:00 - 18:00

Toxicology testing of your product at Konmex BioLabs

We will describe the possibilities of Konmex BioLabs to test:
  • chemicals,
  • cosmetics,
  • personal care products,
  • pharmaceuticals,
  • elastomerics,
  • plastics , other polymeric materials
in terms of IN VITRO, IN VIVO and chemistry testing.

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17.11.2020

Topic

all-day

ISO 10993 biocompatiblity testing - How we do it?

We will answer all of your questions about biocompatiblity testing of your produtcs and:
  • Biological Evaluation Plan (BEP)
  • Biological Evaluation Report (BER)
  • Risk analysis
  • Clinical evaluation
  • Instruction for Use

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14:00 - 18:00

Reprocessing validation of medical devices - How we do it?

We will answer all of your questions about reprocessing validation of your produtcs.
  • Automated cleaning ISO 17664, ISO 15883-1, ISO 15883-5, ASTM 2314, ISO 7864, ISO 10993-5
  • Manual cleaning ISO 17664, ASTM 2314, ISO 7864, ISO 10993-5
  • Disinfection ISO 17664, ASTM 1837, ISO 10993-5
  • Steam sterilization ISO 14937, ISO 17665-1

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18.11.2020

Topic

all-day

ISO 10993 biocompatiblity testing - How we do it?

We will answer all of your questions about biocompatiblity testing of your produtcs and:
  • Biological Evaluation Plan (BEP)
  • Biological Evaluation Report (BER)
  • Risk analysis
  • Clinical evaluation
  • Instruction for Use

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all-day

Package validation of medical devices - How we do it?

We will answer all of your questions about package validation of your produtcs.
  • Bubble emission ISO 11607, ASTM F2096
  • Dye migration ISO 11607, ASTM F1929
  • Burst ISO 11607, ASTM F1140
  • Seal strength ISO 11607, ASTM F88
  • Accelerated aging ASTM F1980

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19.11.2020

Topic

all-day

ISO 10993 biocompatiblity testing - How we do it?

We will answer all of your questions about biocompatiblity testing of your produtcs and:
  • Biological Evaluation Plan (BEP)
  • Biological Evaluation Report (BER)
  • Risk analysis
  • Clinical evaluation
  • Instruction for Use

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14:00 - 18:00

Microbiology and sterility testing of medical devices - How we do it?

We will answer all of your questions about microbiology and sterility testing of your produtcs.
  • Bacteriostasis & Fungistasis (Method Suitability) USP <71>
  • Bioburden method validation USP <1227>
  • Bioburden testing USP <61>
  • Sterility testing USP <71>

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Our range of products

Product categories

  • 07  Medical services and publications
  • 07.01  Reports and analyses
  • 07  Medical services and publications
  • 07.16  Certification and testing of medical devices, quality assurance
  • 07  Medical services and publications
  • 07.17  Other medical services and publications

Our products

Product category: Certification and testing of medical devices, quality assurance

ISO 10993 biocompatiblity testing of medical devices - SPECIAL OFFER!

In response to SARS-CoV-2 pandemic, Konmex BioLabs decides to introduce special offer for comprehensive ISO 10993 biocompatibility testing of medical devices. We strongly believe it will stimulate medical device industry and will support our Customers!

Physical and/or chemical information ISO 10993-18 (Extractables & leachables)
  • Headspace GC-MS (for VOC): 1 200 EUR
  • GC-MS (for SVOC): 1 200 EUR
  • LC-MS (for NVOC): 2 500 EUR
  • ICP-MS (for elements: 900 EUR
Toxicological risk assesment ISO 10993-17
  • Toxicological evaluation of substance or element: 250 EUR
Cytotoxicity ISO 10993-5
  • MEM elution: 300 EUR
  • Direct contact: 300 EUR
  • Agar diffusion: 300 EUR
  • Filter diffusion: 300 EUR
  • MTT/XTT: 350 EUR
  • Neutral red uptake: 300 EUR
Sensitization ISO 10993-10
  • Guinea pig maximization test (GPMT, Magnus-Kligman Maximization): 2 000 EUR
  • Murine Local Lymph Node Assay (LLNA): 1 500 EUR
  • Closed-patch (Buehler): 2 000 EUR
Irritation or Intracutaneous reactivity ISO 10993-10
  • Irritation: 500 EUR
  • Intracutaneous reactivity: 500 EUR
Material mediated pyrogenicity ISO 10993-11
  • Rabbit pyrogen test: 450 EUR
Toxicity ISO 10993-11
  • Acute systemic toxicity: 550 EUR
  • Subacute toxicity: 7 500 EUR
  • Subchronic toxicity: 15 000 EUR
  • Chronic toxicity: 30 000 EUR
Implantation ISO 10993-6
  • 4 week: 1 500 EUR
  • 13 week: 2 400 EUR
Hemocompatibility ISO 10993-4
  • Hemolysis: 500 EUR
  • Coagulation: 450 EUR
  • Platelet activation: 1 500 EUR
  • Complement: 1 500 EUR
Genotoxicity ISO 10993-3
  • Bacterial reverse mutation assay (AMES): 1 500 EUR
  • Mouse Lymphoma Assay (MLA): 7 500 EUR

Please visit our website to check complete offer for medical device testing. If you are looking for any other test, just contact us!

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Product category: Certification and testing of medical devices, quality assurance

Microbiology and sterility testing of medical devices ISO 11737

As Konmex BioLabs we support our Customers in comprehensive microbiology and sterility testing of medical devices according to the ISO 11737-1, ISO 11737-2, and also:

  • Bacteriostasis & Fungistasis (Method Suitability) USP <71>
  • Bioburden method validation USP <1227>
  • Bioburden testing USP <61>
  • Sterility testing USP <71>
If you need any test, just let us know – we will help you on your way!

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Product category: Certification and testing of medical devices, quality assurance

Package validation of medical devices ISO 11607

Konmex BioLabs provide services of medical device packaging validation in compliance with appropriate standards. We conduct various tests to determine package integrity for porous and non-porous materials, among which the most common are:

  • Bubble emission ISO 11607, ASTM F2096
  • Dye migration ISO 11607, ASTM F1929
  • Burst ISO 11607, ASTM F1140
  • Seal strength ISO 11607, ASTM F88
  • Accelerated aging ASTM F1980
Are you looking for appropriate test for your prodcut? Just contact us!

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Product category: Certification and testing of medical devices, quality assurance

Reprocessing validation of medical devices

At Konmex BioLabs we provie a broad range of services for reusable medical devices:

  • Automated cleaning validation ISO 17664, ISO 15883-1, ISO 15883-5, ASTM 2314, ISO 7864, ISO 10993-5
  • Manual cleaning validation ISO 17664, ASTM 2314, ISO 7864, ISO 10993-5
  • Disinfection validation ISO 17664, ASTM 1837, ISO 10993-5
  • Steam sterilization validation ISO 14937, ISO 17665-1
Cleaning validation of single use and reusable medical devices are necessary to confirm the procedures used to clean and disinfect are effective. Sterilization validation process can be applied to medical devices that are cleaned and disinfected. We are developing validation protocols according to the above mentioned standards.

Any questions? Do not hesitate to ask us directly!

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Product category: Reports and analyses, Other medical services and publications

Chemical & Pharmaceutical testing

At Konmex BioLabs we have developed new GLP-certified laboratories dedicated for chemicals, cosmetics, personal care products, pharmaceuticals testing. Here we can conduct all the tests that are listed in annex VII of REACH to cover six human health endpoints.

The List of tests we conduct in our laboratories:

  • Cytotoxicity – tailor-made test that correspond with Acute Toxicity
  • Genotoxicity OECD 471, OECD 490
  • Skin corrosion OECD 431
  • Skin irritation OECD 439
  • Eye irritation OECD 492
  • Skin sensitization OECD 442
Shall you be interested in any of them or you are looking for another test? Please contact us!

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Product category: Reports and analyses, Other medical services and publications

Toxicology testing

We offer in vivo acute, long-term toxicology testing, according with the OECD guidelines. This toxicological test are necessary for registration chemical substances, for instance in accordance with the Regulation No. 1907/2006 of the European Parliament, of the Council of December 2006 (REACH Annex VIII, IX, X), Regulation No. 1272/2008 of the European Parliament, of the Council of 16 December 2008 (CLP).

The List of tests we conduct in our laboratories:

  • Acute Oral Toxicity – Fixed Dose Procedure OECD 420
  • Acute Oral Toxicity – Acute Toxic Class Method OECD 423
  • Acute Oral Toxicity – Up-,-Down-Procedure (UDP) OECD 425
  • Acute Dermal Toxicity: Fixed Dose Procedure OECD 402
  • Acute Dermal Irritation/Corrosion OECD 404
  • Acute Eye Irritation/Corrosion OECD 405
  • Local lymph node assay: BRDU-ELISA OECD 442B
  • Skin Sensitization OECD 406
  • Repeated Dose 28-Day Toxicity Study in Rodents OECD 407
  • Repeated Dose Dermal Toxicity: 21/28-day Study OECD 410
  • Repeated dose 90-day toxicity study in rodents OECD 408
  • Subchronic Dermal Toxicity: 90-day Study OECD 411
  • Chronic Toxicity Studies OECD 452
  • Carcinogenicity studies OECD 451
  • Combined chronic toxicity\carcinogenicity studies OECD 453
  • Prenatal developmental toxicity study OECD 414
  • Reproduction/Developmental Toxicity Screening Test OECD 421
  • Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test OECD 422
  • Extended one-generation reproductive toxicity study OECD 443
  • Two-Generation Reproduction Toxicity Study OECD 416
  • Neurotoxicity Study in Rodents OECD 424
  • Rodent Dominant Lethal Test OECD 478
  • Bacterial Reverse Mutation Test OECD 471
  • In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene OECD 490
We have our own animal facility and in vitro laboratories that are GLP-certified for testing mentioned above.

Are you looking for another OECD test? Please send us a query!

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Product category: Reports and analyses, Other medical services and publications

USP <87> and <88> testing

Biological reactivity tests of elastomerics, plastics, other polymeric materials that have direct or indirect contact with the patient were designed to determine the biological in vitro, in vivo response. Based on different plastics class, various tests need to be conducted, according to Table 1: Classification of Plastics of USP <88> , USP <87>.

We do in our laboratories the following tests:

  • Cytotoxicity: Agar diffusion test or Direct contact test or Elution test
  • Systemic injection test
  • Intracutaneous test
  • Implantation test
We have our own animal facility and in vitro laboratories that are GLP-certified for testing mentioned above.

Do you have any material to be tested? Please send us a query!

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About us

Company details

Welcome to Konmex BioLabs!

We are specialized in comprehensive biocompatibility testing according to the all series of ISO 10993 biological evaluation of medical devices – but not only! We are constantly developing our labs to offer more services for your medical devices:

  • Microbiology and sterility testing
  • Package validation
  • Reprocessing validation
  • Consulting services

In Konmex BioLabs you can also order biological reactivity tests, toxicology, and safety tests of:

  • Raw materials (elastomerics, plastics, and other polymeric materials)
  • Chemicals, pharmaceuticals
  • Cosmetics, personal care products

Our high standard equipment and qualified personnel let us test efficiently, precisely, and fast. We have passed the Good Laboratory Practice (GLP) certification, and ISO 17025 accredittion. We care about quality and reproducibility of our results.


The wide range of tests conducted here makes the product development process short and cost-effective. Just contact us to talk about your needs!

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Company data

Export content

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Number of employees

20-49

Area of business

Medical Services and Publications