🇵🇱 UNIWERSYTET MEDYCZNY W ŁODZI PL
Other
UNIWERSYTET MEDYCZNY W ŁODZI is a laboratory accredited by PCA under number AB 1659 (Łódź, Poland). Its accreditation scope covers 16 test methods in the following areas: Other. Test objects include: Medical devices.
At a glance
- Accreditation number: PCA AB 1659
- Methods in scope: 16
- Types of test objects: 1
- City: Łódź, Poland
- Accreditation number
- AB 1659
- Accreditation body
- PCA
- Address
- al. Kościuszki 4, 90-419 Łódź, ZWIERZĘTARNIA WYDZIAŁU FARMACEUTYCZNEGO, ul. Muszyńskiego 1
- City
- Łódź, Poland
What this laboratory tests (1)
- Medical devices — 16 methods
Accreditation scope — test methods (16)
| No. | Test object | Methodology / Parameters | Technique | Reference document | |
|---|---|---|---|---|---|
| Test methods | |||||
| 1 | Medical devices | In vitro cytotoxicity MTT method | PN-EN ISO 10993-5:2009 | ||
| 2 | Medical devices | In vitro cytotoxicity XTT method | |||
| 3 | Medical devices | In vitro cytotoxicity NRU method | |||
| 4 | Medical devices | In vitro cytotoxicity CF method Clonogenic assay | |||
| 5 | Medical devices | In vitro cytotoxicity Agar diffusion method | |||
| 6 | Medical devices | In vivo skin sensitisation Buehler test | ISO 10993-10:2021 | ||
| 7 | Medical devices | Sensitisation in the GPMT test | ISO 10993-10:2021 | ||
| 8 | Medical devices | Irritant effects in the rabbit skin irritation test | ISO 10993-23:2021 | ||
| 9 | Medical devices | Irritant effects in the intracutaneous reactivity test in the rabbit | ISO 10993-23:2021 | ||
| 10 | Medical devices | Local reaction after implantation in vivo Subcutaneous implantation | PN-EN ISO 10993-6:2017-04 | ||
| 11 | Medical devices | Local reaction after implantation in vivo Subcutaneous implantation | EN ISO 10993-6:2016 | ||
| 12 | Medical devices | Irritant effect by the method using reconstructed human epidermis | ISO 10993-23:2021 | ||
| 13 | Medical devices | Local reaction after implantation in vivo – intramuscular implantation | PN-EN ISO 10993-6:2017-04 | ||
| 14 | Medical devices | Local reaction after implantation in vivo – intramuscular implantation | EN ISO 10993-6:2016 | ||
| 15 | Medical devices | In vivo systemic toxicity testing | PN-EN ISO 10993-11:2018-08 | ||
| 16 | Medical devices | Testing of pyrogenic action in vivo | PN-EN ISO 10993-11:2018-08 | ||
Reference standards (6)
EN ISO 10993-6:2016
ISO 10993-10:2021
ISO 10993-23:2021
PN-EN ISO 10993-11:2018-08
PN-EN ISO 10993-5:2009
PN-EN ISO 10993-6:2017-04