HIGHPOWER Validation Testing & Lab Services
125 Highpower Road, 14623, Rochester, NY, United States
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Register record
- A2LARefreshed
- 3718.01Active
Accredited standards
11Our 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
ISO 11138-1Sterilization of health care products - Biological indicators - Part 1: General requirements
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
ISO 11140-1Sterilization of health care products - Chemical indicators - Part 1: General requirements
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
ISO 11607-1Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
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
ISO 14937Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
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
ISO 15883-1Washer-disinfectors - Part 1: General requirements, terms and definitions and tests
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
ISO 15883-2Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices
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
ISO 17665-1Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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
ISO 22441Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
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
Other standards
ASTM F1929Name not checked yet
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
ASTM F1980Name not checked yet
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
USP 55Name not checked yet
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
Scope as published by A2LA
3 lines
ISO/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 | For the tests to which this accreditation applies, please refer to the laboratory’s Biological Scope of Accreditation.
Accredited Laboratory
A2LA has accredited
HIGHPOWER VALIDATION TESTING & LAB SERVICES INC.
Rochester, NY
for technical competence in the field of
Biological 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 3718.01
Valid to December 31, 2026 | ||
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.