🇵🇱 EUROPEJSKI INSTYTUT BIOMEDYCZNY PL
Microbiology
EUROPEJSKI INSTYTUT BIOMEDYCZNY is a laboratory accredited by PCA under number AB 1763 (Warszawa, Poland). Its accreditation scope covers 34 test methods in the following areas: Microbiology. Test objects include: Medical devices, Medical devices E. Most frequently used techniques: Gas chromatography method, Gas chromatography with mass spectrometry (GC-MS), Immunochemical method (ELISA).
At a glance
- Accreditation number: PCA AB 1763
- Methods in scope: 34
- Types of test objects: 2
- Techniques used: 14
- City: Warszawa, Poland
- Accreditation number
- AB 1763
- Accreditation body
- PCA
- Address
- Spółka z ograniczoną odpowiedzialnością, ul. Bartycka 63A lok. 6, 00-716 Warszawa
- City
- Warszawa, Poland
What this laboratory tests (2)
- Medical devices — 27 methods
- Medical devices E — 7 methods
Analytical techniques used (14)
- Gas chromatography method — 2 methods
- Gas chromatography with mass spectrometry (GC-MS) — 2 methods
- Immunochemical method (ELISA) — 2 methods
- In vitro method — 2 methods
- Liquid chromatography with mass spectrometry (LC-MS) — 2 methods
- Agar diffusion method — 1 method
- Gas chromatography with a flame ionization detector (GC-FID) — 1 method
- Headspace gas chromatography with mass spectrometry (HS-GC-MS) — 1 method
- Inductively coupled plasma mass spectrometry (ICP-MS) — 1 method
- MEM Elution method — 1 method
- Membrane filtration method — 1 method
- Method: - direct - indirect — 1 method
- Method: direct immersion of the product in the medium — 1 method
- MTT method — 1 method
Accreditation scope — test methods (34)
| No. | Test object | Methodology / Parameters | Technique | Reference document | |
|---|---|---|---|---|---|
| Test methods | |||||
| 1 | Medical devices | Genotoxicity - AMES | PN-EN ISO 10993-3:2014-12 | ||
| 2 | Medical devices | Haemolysis | Method: - direct - indirect | PN-EN ISO 10993-4:2018-02 | |
| 3 | Medical devices | Haemocompatibility – determination of blood coagulation | In vitro method | PN-EN ISO 10993-4:2018-02 | |
| 4 | Medical devices | Haemocompatibility – platelet activation | Immunochemical method (ELISA) | PN-EN ISO 10993-4:2018-02 | |
| 5 | Medical devices | Haemocompatibility – determination of haematological blood parameters | In vitro method | PN-EN ISO 10993-4:2018-02 | |
| 6 | Medical devices | Haemocompatibility – complement system activation | Immunochemical method (ELISA) | PN-EN ISO 10993-4:2018-02 | |
| 7 | Medical devices | In vitro cytotoxicity | Agar diffusion method | PN-EN ISO 10993-5:2009 | |
| 8 | Medical devices | In vitro cytotoxicity | MEM Elution method | PN-EN ISO 10993-5:2009 | |
| 9 | Medical devices | In vitro cytotoxicity | MTT method | PN-EN ISO 10993-5:2009 | |
| 10 | Medical devices | In vitro irritation | PN-EN ISO 10993-23:2021-08 | ||
| 11 | Medical devices | In vivo intracutaneous irritant effect | PN-EN ISO 10993-23:2021-08 | ||
| 12 | Medical devices | In vivo irritant effect | PN-EN ISO 10993-23:2021-08 | ||
| 13 | Medical devices | In vivo sensitisation - GPMT | ISO 10993-10:2021 | ||
| 14 | Medical devices | In vivo sensitisation Buehler test | ISO 10993-10:2021 | ||
| 15 | Medical devices | In vivo sensitisation - LLNA | ISO 10993-10:2021 | ||
| 16 | Medical devices | In vivo pyrogenic effect | PN-EN ISO 10993-11:2018-08 | ||
| 17 | Medical devices | Acute toxicity in vivo | PN-EN ISO 10993-11:2018-08 | ||
| 18 | Medical devices | Subacute toxicity in vivo | PN-EN ISO 10993-11:2018-08 | ||
| 19 | Medical devices | Subchronic toxicity in vivo | PN-EN ISO 10993-11:2018-08 | ||
| 20 | Medical devices | Chronic toxicity in vivo | PN-EN ISO 10993-11:2018-08 | ||
| 21 | Medical devices | In vivo implantation testing | PN-EN ISO 10993-6:2017-04 | ||
| 22 | Medical devices | Count of aerobic microorganisms (bacteria) on products | Membrane filtration method | PN-EN ISO 11737 -1:2018-03 | PN-EN ISO 11737 -1:2018-03 / A1:2021-11 | |
| 23 | Medical devices | Sterility of the product | Method: direct immersion of the product in the medium | PN-EN ISO 11737-2:2020 | |
| 24 | Medical devices | Presence of substances inhibiting the growth of microorganisms, Method suitability test for sterility: bacteriostasis/ fungistasis test | PN-EN ISO 11737-2:2020 | ||
| 25 | Medical devices | Level of bacterial endotoxins | ISO 11737-3:2023 | ||
| 26 | Medical devices | Residue after ethylene oxide sterilisation Ethylene oxide 1.0-60 mg/L Ethylene chlorohydrin 1.0-60 mg/L |
Headspace gas chromatography with mass spectrometry (HS-GC-MS) | PN-EN ISO 10993-7:2009 | |
| 27 | Medical devices E | Identification of extracted / leachable substances: identification confirmation of the identity of compounds in the mass range 1.2-1100 using mass spectra libraries with the use of a standard Semi-quantitative composition (volatile compounds) HeadSpace with mass spectrometry (HSGC-MS) |
Gas chromatography method | PN-EN ISO 10993-18:2020-11 | |
| 28 | Medical devices E | Identification of extracted / leachable substances: identification confirmation of the identity of compounds in the mass range 1.2-1100 using mass spectra libraries with the use of a standard Semi-quantitative composition (semi-volatile compounds) |
Gas chromatography with mass spectrometry (GC-MS) | PN-EN ISO 10993-18:2020-11 | |
| 29 | Medical devices E | Identification of extracted / leachable substances: identification confirmation of the identity of compounds in the mass range 40-3000 using mass spectra libraries with the use of a standard Semi-quantitative composition (non-volatile compounds) |
Liquid chromatography with mass spectrometry (LC-MS) | PN-EN ISO 10993-18:2020-11 | |
| 30 | Medical devices | Residue after ethylene oxide sterilisation | Gas chromatography with a flame ionization detector (GC-FID) | PN-EN ISO 10993-7:2009 | |
| 31 | Medical devices E | Identification of extracted / leachable substances: identification confirmation of the identity of compounds in the mass range 1.2-1100 using mass spectra libraries with the use of a standard Semi-quantitative composition (volatile compounds) HeadSpace with mass spectrometry (HSGC-MS) |
Gas chromatography method | PN-EN ISO 10993-18:2020-11 | |
| 32 | Medical devices E | Identification of extracted / leachable substances: identification confirmation of the identity of compounds in the mass range 1.2-1100 using mass spectra libraries with the use of a standard Semi-quantitative composition (semi-volatile compounds) |
Gas chromatography with mass spectrometry (GC-MS) | PN-EN ISO 10993-18:2020-11 | |
| 33 | Medical devices E | Identification of extracted / leachable substances: identification confirmation of the identity of compounds in the mass range 40-3000 using mass spectra libraries with the use of a standard Semi-quantitative composition (non-volatile compounds) |
Liquid chromatography with mass spectrometry (LC-MS) | PN-EN ISO 10993-18:2020-11 | |
| 34 | Medical devices E | Analysis of extracted / leachable substances, element concentration | Inductively coupled plasma mass spectrometry (ICP-MS) | PN-EN ISO 10993-18:2020-11 | |
Reference standards (13)
ISO 10993-10:2021
ISO 11737-3:2023
PN-EN ISO 10993-11:2018-08
PN-EN ISO 10993-18:2020-11
PN-EN ISO 10993-23:2021-08
PN-EN ISO 10993-3:2014-12
PN-EN ISO 10993-4:2018-02
PN-EN ISO 10993-5:2009
PN-EN ISO 10993-6:2017-04
PN-EN ISO 10993-7:2009
PN-EN ISO 11737 -1:2018-03
PN-EN ISO 11737 -1:2018-03 / A1:2021-11
PN-EN ISO 11737-2:2020