TUV SUD America
141 14th Street NW, 55112, New Brighton, MN, United States
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Register record
- A2LARefreshed
- 2955.22Active
- 2955.23Active
Accredited standards
3Our reading of the A2LA 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 10993-12Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 10993-12; ISO 10993-18; USP 643
ISO 10993-12; ISO 10993-18; USP 643
ISO 10993-18Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
ISO 10993-12; ISO 10993-18; USP 643
ISO 10993-12; ISO 10993-18; USP 643
USP 643Name not checked yet
ISO 10993-12; ISO 10993-18; USP 643
ISO 10993-12; ISO 10993-18; USP 643
Scope as published by A2LA
4 lines
ISO/IEC 17025
Active2955.22
The scope document we hold says it is valid until 2027-05-31.
Accredited scope, certificate 2955.22
| Line | Discipline | Method | Matrix | Range |
|---|---|---|---|---|
| 1 | chemical | ISO 10993-12; ISO 10993-18; USP 643 | active and nonactive medical devices, components, and raw materials | - |
| 2 | chemical | For the tests to which this accreditation applies, please refer to the laboratory’s Chemical Scope of Accreditation.
Accredited Laboratory
A2LA has accredited
TUV SUD AMERICA, INC.
New Brighton, MN
for technical competence in the field of
Chemical Testing
This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017
General requirements for the competence of testing and calibration laboratories. This accreditation demonstrates
technical competence for a defined scope and the operation of a laboratory quality management system
(refer to joint ISO-ILAC-IAF Communiqué dated April 2017).
Presented this 27th day of February 2025.
_______________________
Mr. Trace McInturff, Vice President, Accreditation Services
For the Accreditation Council
Certificate Number 2955.22
Valid to May 31, 2027 | ||
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
Active2955.23
The scope document we hold says it is valid until 2027-05-31.
Accredited scope, certificate 2955.23
| Line | Discipline | Method | Matrix | Range |
|---|---|---|---|---|
| 1 | chemical | ISO 10993-12; ISO 10993-18; USP 643 | active and nonactive medical devices, components, and raw materials | - |
| 2 | chemical | For the tests to which this accreditation applies, please refer to the laboratory’s Chemical Scope of Accreditation.
Accredited Laboratory
A2LA has accredited
TUV SUD AMERICA, INC.
New Brighton, MN
for technical competence in the field of
Chemical Testing
This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017
General requirements for the competence of testing and calibration laboratories. This accreditation demonstrates
technical competence for a defined scope and the operation of a laboratory quality management system
(refer to joint ISO-ILAC-IAF Communiqué dated April 2017).
Presented this 27th day of February 2025.
_______________________
Mr. Trace McInturff, Vice President, Accreditation Services
For the Accreditation Council
Certificate Number 2955.22
Valid to May 31, 2027 | ||
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
Other Locations
1 other site in this organization
Accreditation data refreshed from the A2LA register on .
This page mirrors a public register. For a purchasing, audit or regulatory decision, confirm against the A2LA entry linked above.