🇵🇱 EUROPEJSKI INSTYTUT BIOMEDYCZNY PL
微生物
EUROPEJSKI INSTYTUT BIOMEDYCZNY 是由 PCA 认可的实验室，认可编号 AB 1763（Warszawa，波兰）。认可范围涵盖 34 项检测方法，涉及以下领域：微生物。检测对象包括：医疗器械、Medical devices E。最常用的技术：Gas chromatography method、Gas chromatography with mass spectrometry (GC-MS)、Immunochemical method (ELISA)。
要点速览
- 认可编号: PCA AB 1763
- 认可范围内方法数: 34
- 检测对象种类: 2
- 所用技术数: 14
- 城市: Warszawa, 波兰
- 认可编号
- AB 1763
- 认可机构
- PCA
- 地址
- Spółka z ograniczoną odpowiedzialnością, ul. Bartycka 63A lok. 6, 00-716 Warszawa
- 城市
- Warszawa, 波兰
该实验室检测什么 (2)
- 医疗器械 — 27 项方法
- Medical devices E — 7 项方法
所用检测技术 (14)
- Gas chromatography method — 2 项方法
- Gas chromatography with mass spectrometry (GC-MS) — 2 项方法
- Immunochemical method (ELISA) — 2 项方法
- In vitro method — 2 项方法
- Liquid chromatography with mass spectrometry (LC-MS) — 2 项方法
- Agar diffusion method — 1 项方法
- Gas chromatography with a flame ionization detector (GC-FID) — 1 项方法
- Headspace gas chromatography with mass spectrometry (HS-GC-MS) — 1 项方法
- MEM Elution method — 1 项方法
- Method: - direct - indirect — 1 项方法
- Method: direct immersion of the product in the medium — 1 项方法
- MTT method — 1 项方法
- 电感耦合等离子体质谱法（ICP-MS） — 1 项方法
- 膜过滤法 — 1 项方法
认可范围 — 项检测方法 (34)
| 序号 | 检测对象 | 方法 / 参数 | 技术 | 依据文件 | |
|---|---|---|---|---|---|
| 检测方法 | |||||
| 1 | 医疗器械 | Genotoxicity - AMES | PN-EN ISO 10993-3:2014-12 | ||
| 2 | 医疗器械 | Haemolysis | Method: - direct - indirect | PN-EN ISO 10993-4:2018-02 | |
| 3 | 医疗器械 | Haemocompatibility – determination of blood coagulation | In vitro method | PN-EN ISO 10993-4:2018-02 | |
| 4 | 医疗器械 | Haemocompatibility – platelet activation | Immunochemical method (ELISA) | PN-EN ISO 10993-4:2018-02 | |
| 5 | 医疗器械 | Haemocompatibility – determination of haematological blood parameters | In vitro method | PN-EN ISO 10993-4:2018-02 | |
| 6 | 医疗器械 | Haemocompatibility – complement system activation | Immunochemical method (ELISA) | PN-EN ISO 10993-4:2018-02 | |
| 7 | 医疗器械 | In vitro cytotoxicity | Agar diffusion method | PN-EN ISO 10993-5:2009 | |
| 8 | 医疗器械 | In vitro cytotoxicity | MEM Elution method | PN-EN ISO 10993-5:2009 | |
| 9 | 医疗器械 | In vitro cytotoxicity | MTT method | PN-EN ISO 10993-5:2009 | |
| 10 | 医疗器械 | In vitro irritation | PN-EN ISO 10993-23:2021-08 | ||
| 11 | 医疗器械 | In vivo intracutaneous irritant effect | PN-EN ISO 10993-23:2021-08 | ||
| 12 | 医疗器械 | In vivo irritant effect | PN-EN ISO 10993-23:2021-08 | ||
| 13 | 医疗器械 | In vivo sensitisation - GPMT | ISO 10993-10:2021 | ||
| 14 | 医疗器械 | In vivo sensitisation Buehler test | ISO 10993-10:2021 | ||
| 15 | 医疗器械 | In vivo sensitisation - LLNA | ISO 10993-10:2021 | ||
| 16 | 医疗器械 | In vivo pyrogenic effect | PN-EN ISO 10993-11:2018-08 | ||
| 17 | 医疗器械 | Acute toxicity in vivo | PN-EN ISO 10993-11:2018-08 | ||
| 18 | 医疗器械 | Subacute toxicity in vivo | PN-EN ISO 10993-11:2018-08 | ||
| 19 | 医疗器械 | Subchronic toxicity in vivo | PN-EN ISO 10993-11:2018-08 | ||
| 20 | 医疗器械 | Chronic toxicity in vivo | PN-EN ISO 10993-11:2018-08 | ||
| 21 | 医疗器械 | In vivo implantation testing | PN-EN ISO 10993-6:2017-04 | ||
| 22 | 医疗器械 | Count of aerobic microorganisms (bacteria) on products | 膜过滤法 | PN-EN ISO 11737 -1:2018-03 | PN-EN ISO 11737 -1:2018-03 / A1:2021-11 | |
| 23 | 医疗器械 | Sterility of the product | Method: direct immersion of the product in the medium | PN-EN ISO 11737-2:2020 | |
| 24 | 医疗器械 | Presence of substances inhibiting the growth of microorganisms, Method suitability test for sterility: bacteriostasis/ fungistasis test | PN-EN ISO 11737-2:2020 | ||
| 25 | 医疗器械 | Level of bacterial endotoxins | ISO 11737-3:2023 | ||
| 26 | 医疗器械 | 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 | 医疗器械 | 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 | 电感耦合等离子体质谱法（ICP-MS） | PN-EN ISO 10993-18:2020-11 | |
引用标准 (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