ScopeGBA Medical Device Services
Official name: GBA Medical Device Services GmbH
31 capabilities
Accredited since November 2023
Verified Apr 2026
One of 3,039 in Germany
Details
Lilienthalstraße 4
Gilching 82205 , Germany
Gilching 82205 , Germany
Accreditation
Active
DAkkS
D-PL-13392-01-00
Conducts biocompatibility, sterility, and microbiological-hygienic testing of medical devices and biomaterials, including sterilization validation, sterilisation barrier and packaging assessments, and environmental monitoring.
Accreditation Details
Accreditation Body
DAkkS
Number
D-PL-13392-01-00
Status
ActiveSince
14 November 2023
Accreditation is granted under EU Regulation 765/2008 and assessed against ISO/IEC 17025. Data sourced from official DAkkS records.
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Test Capabilities (31)
| Standard Reference | Description | Category |
|---|---|---|
| DIN EN 993-1 (2019-03) | DIN EN ISO 10993-1 | Biocompatibility (ISO 10993) |
| DIN EN 993-18 (2002-11) | DIN EN ISO 10993-18 | Biocompatibility (ISO 10993) |
| DIN EN 993-5 (2019-03) | DIN EN ISO 10993-5 | Biocompatibility (ISO 10993) |
| DIN EN ISO 10993-12 | ISO 10993-12 | Biocompatibility (ISO 10993) |
| DIN EN ISO 10993-15 | ISO 10993-15 | Biocompatibility (ISO 10993) |
| DIN EN ISO 10993-4 | ISO 10993-4 | Biocompatibility (ISO 10993) |
| DIN EN ISO 10993-9 | ISO 10993-9 | Biocompatibility (ISO 10993) |
| DIN EN ISO 11979-5 | ISO 11979-5 | Chromatography (GC, HPLC) |
| DIN EN 1422 | VDA 621-422 | Climate / Temperature Cycling |
| DIN EN 1040 | DIN EN 1040 | REACH Substance Testing |
| DIN EN 1275 | DIN EN IEC 60601-2-75 | REACH Substance Testing |
| DIN 58953-6 | DIN 58953-6 | Sterility Testing |
| DIN EN 17372 (2021-09) | DIN EN ISO 11737-2 | Sterility Testing |
| DIN EN 6072 (2011-06) | DIN EN ISO 11607-2 | Sterility Testing |
| DIN EN ISO 11135 | DIN EN ISO 11135 | Sterility Testing |
| DIN EN ISO 11137-1 | DIN EN ISO 11137-1 | Sterility Testing |
| DIN EN ISO 11137-2 | DIN EN ISO 11137-2 | Sterility Testing |
| DIN EN ISO 14729 | DIN EN ISO 14729 | Sterility Testing |
| DIN EN ISO 14730 | DIN EN ISO 14730 | Sterility Testing |
| DIN EN ISO 14937 | DIN EN ISO 14937 | Sterility Testing |
| DIN EN ISO 17664 | DIN EN ISO 17664 | Sterility Testing |
| DIN EN ISO 17665-1 | DIN EN ISO 17665-1 | Sterility Testing |
| ISO 8573-7 | ISO 8573-7 | Sterility Testing |
| DIN EN ISO 14698-1 | ISO 14698-1 | Technical Cleanliness |
| DIN EN ISO 14698-2 | ISO 14698-2 | Technical Cleanliness |
| DIN 16868-2 (2016-10) | DIN 16868-2 | Tensile / Compression / Flexural |
| DIN EN ISO 11607-1 | BS EN ISO 11607-1:2020+A11 | Tensile / Compression / Flexural |
| DIN EN ISO 8536-4 | DIN EN ISO 8536-4 | Tensile / Compression / Flexural |
| ISO 19227 | ISO 19227 | Tensile / Compression / Flexural |
| DIN EN ISO 11737-1 | BS EN ISO 11737-1:2018 | Ultrasonic Testing (UT) |
| DIN EN ISO 17405 (2014-10) | DIN EN ISO 17405 | Ultrasonic Testing (UT) |