Element Materials Technology
5929 Baker Road, Suite 430, 55345, Minnetonka, MN, United States
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Register record
- A2LARefreshed
- 2783.01Active
Accredited standards
10Our 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.
ASTM F2129Name not checked yet
ASTM F2477; ISO 25539-1 (Annex D); ISO 7198 (Annex A); ASTM F2942; ISO 7198 (Annex A); ISO 25539-1 (Annex D); ISO 25539-2 (Annex D); ASTM F3821 (Annex A1 and A2); ISO 148011; ASTM F2129
ASTM F2477Name not checked yet
ASTM F2477; ISO 25539-1 (Annex D); ISO 7198 (Annex A); ASTM F2942; ISO 7198 (Annex A); ISO 25539-1 (Annex D); ISO 25539-2 (Annex D); ASTM F3821 (Annex A1 and A2); ISO 148011; ASTM F2129
ASTM F2942Name not checked yet
ASTM F2477; ISO 25539-1 (Annex D); ISO 7198 (Annex A); ASTM F2942; ISO 7198 (Annex A); ISO 25539-1 (Annex D); ISO 25539-2 (Annex D); ASTM F3821 (Annex A1 and A2); ISO 148011; ASTM F2129
ASTM F3821Name not checked yet
ASTM F2477; ISO 25539-1 (Annex D); ISO 7198 (Annex A); ASTM F2942; ISO 7198 (Annex A); ISO 25539-1 (Annex D); ISO 25539-2 (Annex D); ASTM F3821 (Annex A1 and A2); ISO 148011; ASTM F2129
ISO 7198Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
ASTM F2477; ISO 25539-1 (Annex D); ISO 7198 (Annex A); ASTM F2942; ISO 7198 (Annex A); ISO 25539-1 (Annex D); ISO 25539-2 (Annex D); ASTM F3821 (Annex A1 and A2); ISO 148011; ASTM F2129
ISO 10555-1Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
ISO 10555-1 Annex A, B, C, F; ISO 11070 Annex B, C, F, G, H; ISO 20697 Annex A, B, D, E
ISO 11070Sterile single-use intravascular introducers, dilators and guidewires
ISO 10555-1 Annex A, B, C, F; ISO 11070 Annex B, C, F, G, H; ISO 20697 Annex A, B, D, E
ISO 20697Sterile drainage catheters and accessory devices for single use
ISO 10555-1 Annex A, B, C, F; ISO 11070 Annex B, C, F, G, H; ISO 20697 Annex A, B, D, E
ISO 25539-1Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
ASTM F2477; ISO 25539-1 (Annex D); ISO 7198 (Annex A); ASTM F2942; ISO 7198 (Annex A); ISO 25539-1 (Annex D); ISO 25539-2 (Annex D); ASTM F3821 (Annex A1 and A2); ISO 148011; ASTM F2129
ISO 25539-2Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
ASTM F2477; ISO 25539-1 (Annex D); ISO 7198 (Annex A); ASTM F2942; ISO 7198 (Annex A); ISO 25539-1 (Annex D); ISO 25539-2 (Annex D); ASTM F3821 (Annex A1 and A2); ISO 148011; ASTM F2129
Scope as published by A2LA
3 lines
ISO/IEC 17025
Active2783.01
The scope document we hold says it is valid until 2027-05-31.
Accredited scope, certificate 2783.01
| Line | Discipline | Method | Matrix | Range |
|---|---|---|---|---|
| 1 | mechanical | ASTM F2477; ISO 25539-1 (Annex D); ISO 7198 (Annex A); ASTM F2942; ISO 7198 (Annex A); ISO 25539-1 (Annex D); ISO 25539-2 (Annex D); ASTM F3821 (Annex A1 and A2); ISO 148011; ASTM F2129 | Medical devices | - |
| 2 | mechanical | ISO 10555-1 Annex A, B, C, F; ISO 11070 Annex B, C, F, G, H; ISO 20697 Annex A, B, D, E | Intravascular Catheters; Sterile single-use intravascular introducers, dilators and guidewires; Sterile drainage catheters and accessory devices for single use | - |
| 3 | mechanical | For the tests to which this accreditation applies, please refer to the laboratory’s Mechanical Scope of Accreditation.
Accredited Laboratory
A2LA has accredited
ELEMENT MATERIALS TECHNOLOGY
Minnetonka, MN
for technical competence in the field of
Mechanical 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 3rd day of July 2025.
_______________________
Mr. Trace McInturff, Vice President, Accreditation Services
For the Accreditation Council
Certificate Number 2783.01
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
2 other sites in this organization
Labs with overlapping accredited scope in United States
- SterilucentMinneapolis, MN · ~16 kmA2LAShares 1 accredited materialMedical devices
- STERIS Laboratories, Inc.Brooklyn Park, MN · ~20 kmA2LAShares 1 accredited materialMedical devices
- NORTH AMERICAN SCIENCE ASSOCIATES, LLC (NAMSA)St. Paul, MN · ~29 kmA2LAShares 1 accredited materialMedical devices
- TUV SUD America - Auburn HillsAuburn Hills, MI · ~857 kmA2LAShares 1 accredited materialMedical devices
- HIGHPOWER Validation Testing & Lab ServicesRochester, NY · ~1,280 kmA2LAShares 1 accredited materialMedical devices
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.