BerlinAnalytix
Ullsteinstraße 108, 12109, Berlin, Germany
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Register record
- DAKKSRefreshed
- D-PL-22207-02-01Active
- D-PL-22207-02-00Active
Accredited standards
3Our reading of the DAKKS scope: each standard once, with its official name where we have checked it. Click a standard to see the scope line it comes from, word for word.
ISO 10993-1Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
DIN EN ISO 10993-6; DIN EN ISO 10993-1; DIN EN ISO 10993-12
DIN EN ISO 10993-6; DIN EN ISO 10993-1
ISO 10993-6Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
DIN EN ISO 10993-6; DIN EN ISO 10993-1; DIN EN ISO 10993-12
DIN EN ISO 10993-6; DIN EN ISO 10993-1
ISO 10993-12Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
DIN EN ISO 10993-6; DIN EN ISO 10993-1; DIN EN ISO 10993-12
Scope as published by DAKKS
4 lines
ISO/IEC 17025
ActiveD-PL-22207-02-01
Accredited scope, certificate D-PL-22207-02-01
| Line | Discipline | Method | Matrix | Range |
|---|---|---|---|---|
| 1 | biological | DIN EN ISO/IEC 17025:2018 | Medizinprodukten | - |
| 2 | biological | DIN EN ISO 10993-6; DIN EN ISO 10993-1 | Medizinprodukte | - |
Ranges are reproduced from the accredited scope document as published. An absent range means the register did not state one. Line numbers are ours, for cross-reference; they follow the order of the scope document.
ISO/IEC 17025
ActiveD-PL-22207-02-00
Accredited scope, certificate D-PL-22207-02-00
| Line | Discipline | Method | Matrix | Range |
|---|---|---|---|---|
| 1 | biological | - | Pharmaceuticals | - |
| 2 | biological | DIN EN ISO 10993-6; DIN EN ISO 10993-1; DIN EN ISO 10993-12 | - | - |
Ranges are reproduced from the accredited scope document as published. An absent range means the register did not state one. Line numbers are ours, for cross-reference; they follow the order of the scope document.
Location
Labs with overlapping accredited scope in Germany
- FREY-TOXHerzberg · ~86 kmDAKKSShares 2 accredited methods and materialsISO 10993-12Pharmaceuticals
- Ostthüringische Materialprüfgesellschaft für Textil und Kunststoffe mbH RudolstadtRudolstadt · ~242 kmDAKKSShares 2 accredited methods and materialsISO 10993-12Pharmaceuticals
- Tentamus Pharma & Med DeutschlandBad Kissingen · ~339 kmDAKKSShares 2 accredited methods and materialsISO 10993-12Pharmaceuticals
- Eurofins Medical Device Testing MunichPlanegg · ~503 kmDAKKSShares 2 accredited methods and materialsISO 10993-12Pharmaceuticals
- BSL Bioservice Scientific Laboratories MunichPlanegg · ~503 kmDAKKSShares 2 accredited methods and materialsISO 10993-12Pharmaceuticals
Accreditation data refreshed from the DAKKS register on .
This page mirrors a public register. For a purchasing, audit or regulatory decision, confirm against the DAKKS entry linked above.