ViVitro Labs, Inc.
Victoria, Canada
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Register record
- A2LARefreshed
- 3224.01Active
Accredited standards
6Our 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 F2743Name not checked yet
ISO 25539-2; ASTM F2743; AAMI TIR42; FDA guidance 1545; FDA guidance 1608; ISO 5840-1; ISO 5840-2; ISO 5840-3; ISO 5910; OLE1032; OLE1714; OLE2107; OLE2106
ISO 5840-1Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
ISO 25539-2; ASTM F2743; AAMI TIR42; FDA guidance 1545; FDA guidance 1608; ISO 5840-1; ISO 5840-2; ISO 5840-3; ISO 5910; OLE1032; OLE1714; OLE2107; OLE2106
ISO 5840-1; ISO 5840-2; ISO 5840-3; ISO 5910; ISO 25539-2; FDA Guidance 16007; OLE2307; OLE0811; OLE0813
ISO 5840-2Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
ISO 25539-2; ASTM F2743; AAMI TIR42; FDA guidance 1545; FDA guidance 1608; ISO 5840-1; ISO 5840-2; ISO 5840-3; ISO 5910; OLE1032; OLE1714; OLE2107; OLE2106
ISO 5840-1; ISO 5840-2; ISO 5840-3; ISO 5910; ISO 25539-2; FDA Guidance 16007; OLE2307; OLE0811; OLE0813
ISO 5840-3Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
ISO 25539-2; ASTM F2743; AAMI TIR42; FDA guidance 1545; FDA guidance 1608; ISO 5840-1; ISO 5840-2; ISO 5840-3; ISO 5910; OLE1032; OLE1714; OLE2107; OLE2106
ISO 5840-1; ISO 5840-2; ISO 5840-3; ISO 5910; ISO 25539-2; FDA Guidance 16007; OLE2307; OLE0811; OLE0813
ISO 5910Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
ISO 25539-2; ASTM F2743; AAMI TIR42; FDA guidance 1545; FDA guidance 1608; ISO 5840-1; ISO 5840-2; ISO 5840-3; ISO 5910; OLE1032; OLE1714; OLE2107; OLE2106
ISO 5840-1; ISO 5840-2; ISO 5840-3; ISO 5910; ISO 25539-2; FDA Guidance 16007; OLE2307; OLE0811; OLE0813
ISO 25539-2Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
ISO 25539-2; ASTM F2743; AAMI TIR42; FDA guidance 1545; FDA guidance 1608; ISO 5840-1; ISO 5840-2; ISO 5840-3; ISO 5910; OLE1032; OLE1714; OLE2107; OLE2106
ISO 5840-1; ISO 5840-2; ISO 5840-3; ISO 5910; ISO 25539-2; FDA Guidance 16007; OLE2307; OLE0811; OLE0813
Scope as published by A2LA
3 lines
ISO/IEC 17025
Active3224.01
The scope document we hold says it is valid until 2027-01-31.
Accredited scope, certificate 3224.01
| Line | Discipline | Method | Matrix | Range |
|---|---|---|---|---|
| 1 | mechanical | ISO 25539-2; ASTM F2743; AAMI TIR42; FDA guidance 1545; FDA guidance 1608; ISO 5840-1; ISO 5840-2; ISO 5840-3; ISO 5910; OLE1032; OLE1714; OLE2107; OLE2106 | Medical devices | - |
| 2 | mechanical | ISO 5840-1; ISO 5840-2; ISO 5840-3; ISO 5910; ISO 25539-2; FDA Guidance 16007; OLE2307; OLE0811; OLE0813 | fluids | -200 to 315 mmHg |
| 3 | mechanical | For the types of tests to which this accreditation applies, please refer to the laboratory’s Mechanical Scope of Accreditation.
Accredited Laboratory
A2LA has accredited
VIVITRO LABS, INC.
Victoria, British Columbia, Canada
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 February 2025.
_______________________
Mr. Trace McInturff, Vice President, Accreditation Services
For the Accreditation Council
Certificate Number 3224.01
Valid to January 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.
Other Locations
2 other sites in this organization
Accreditation data refreshed from the A2LA register on .
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