HIGHPOWER Validation Testing & Lab Services
125 Highpower Road, 14623, Rochester, NY, United States
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Register record
- A2LARefreshed
- 3718.01Active
Certificates and scope
1ISO/IEC 17025
Active3718.01
The scope document we hold says it is valid until 2026-12-31.
Accredited scope, certificate 3718.01
| Line | Discipline | Method | Matrix | Range |
|---|---|---|---|---|
| 1 | biological | USP <55>; ANSI/AAMI/ISO 11138-1; ANSI/AAMI/ISO 11140-1; AAMI TIR 17; ASTM F1980; ANSI/AAMI/ISO 11607-1; AAMI TIR22; ASTM F1929; ANSI/AAMI ST77; AAMI TIR 12 | Medical devices | - |
| 2 | biological | AAMI ST98; ISO 22441; FDA Guidance on Premarket Notification 510(k) Submissions for Sterilizers Intended for Use in Health Care Facilities; AAMI ST-08; AAMI ST 55; FDA Guidance on Premarket Notification 510(k) Submissions for Sterilizers Intended for Use in Health Care Facilities; ANSI/AAMI/ISO 14937; ANSI/AAMI/ISO 17665-1; AAMI TIR 12; ISO 15883-1; ISO 15883-2 | Reusable Medical Devices | - |
| 3 | biological | - | - | - |
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 United States
- Oneida Research ServicesReading, PA · ~344 kmA2LAShares 1 accredited materialMedical devices
- TUV SUD America - Auburn HillsAuburn Hills, MI · ~460 kmA2LAShares 1 accredited materialMedical devices
- Packaging ComplianceBillerica, MA · ~521 kmA2LAShares 1 accredited materialMedical devices
- RIH Orthopaedic FoundationProvidence, RI · ~530 kmA2LAShares 1 accredited materialMedical devices
- NORTH AMERICAN SCIENCE ASSOCIATES, LLC (NAMSA)St. Paul, MN · ~1,251 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.