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United States

STERIS Laboratories, Inc.

9303 West Broadway Ave., 55445, Brooklyn Park, MN, United States

A2LA|4350.01A2LA|4350.03ISO/IEC 17025Register refreshed 2026-09-25
Certificates
2
Scope items
6
Standards
11
Locations
2
One of 2 locations. View the organization

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Register record

A2LARefreshed
4350.01Active
4350.03Active

Accredited standards

11

Our 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.

USP

USP 51Name not checked yet
As written on the certificate · Line 1 (A2LA 4350.03)

ISO/IEC 17025:2017; USP <51>; ISO 14698-1; USP <61>; USP <62>; Standard Methods for the Examination of Water and Wastewater

As written on the certificate · Line 1 (A2LA 4350.01)

ISO/IEC 17025:2017; USP <51>; ISO 14698-1; USP <61>; USP <62>; Standard Methods for the Examination of Water and Wastewater

USP 61Name not checked yet
As written on the certificate · Line 1 (A2LA 4350.03)

ISO/IEC 17025:2017; USP <51>; ISO 14698-1; USP <61>; USP <62>; Standard Methods for the Examination of Water and Wastewater

As written on the certificate · Line 1 (A2LA 4350.01)

ISO/IEC 17025:2017; USP <51>; ISO 14698-1; USP <61>; USP <62>; Standard Methods for the Examination of Water and Wastewater

USP 62Name not checked yet
As written on the certificate · Line 1 (A2LA 4350.03)

ISO/IEC 17025:2017; USP <51>; ISO 14698-1; USP <61>; USP <62>; Standard Methods for the Examination of Water and Wastewater

As written on the certificate · Line 1 (A2LA 4350.01)

ISO/IEC 17025:2017; USP <51>; ISO 14698-1; USP <61>; USP <62>; Standard Methods for the Examination of Water and Wastewater

USP 71Name not checked yet
As written on the certificate · Line 2 (A2LA 4350.03)

AAMI/ANSI/ISO 11737-2; USP <71>; AAMI/ANSI/ISO 11737-1; AAMI ST72; USP <85>; <161>; 11737-3; ISO 10993-5; ISO 10993-7; USP <643>

As written on the certificate · Line 2 (A2LA 4350.01)

AAMI/ANSI/ISO 11737-2; USP <71>; AAMI/ANSI/ISO 11737-1; AAMI ST72; USP <85>; <161>; 11737-3; ISO 10993-5; ISO 10993-7; USP <643>

USP 85Name not checked yet
As written on the certificate · Line 2 (A2LA 4350.03)

AAMI/ANSI/ISO 11737-2; USP <71>; AAMI/ANSI/ISO 11737-1; AAMI ST72; USP <85>; <161>; 11737-3; ISO 10993-5; ISO 10993-7; USP <643>

As written on the certificate · Line 2 (A2LA 4350.01)

AAMI/ANSI/ISO 11737-2; USP <71>; AAMI/ANSI/ISO 11737-1; AAMI ST72; USP <85>; <161>; 11737-3; ISO 10993-5; ISO 10993-7; USP <643>

USP 643Name not checked yet
As written on the certificate · Line 2 (A2LA 4350.03)

AAMI/ANSI/ISO 11737-2; USP <71>; AAMI/ANSI/ISO 11737-1; AAMI ST72; USP <85>; <161>; 11737-3; ISO 10993-5; ISO 10993-7; USP <643>

As written on the certificate · Line 2 (A2LA 4350.01)

AAMI/ANSI/ISO 11737-2; USP <71>; AAMI/ANSI/ISO 11737-1; AAMI ST72; USP <85>; <161>; 11737-3; ISO 10993-5; ISO 10993-7; USP <643>

ISO

ISO 10993-5Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
As written on the certificate · Line 2 (A2LA 4350.03)

AAMI/ANSI/ISO 11737-2; USP <71>; AAMI/ANSI/ISO 11737-1; AAMI ST72; USP <85>; <161>; 11737-3; ISO 10993-5; ISO 10993-7; USP <643>

As written on the certificate · Line 2 (A2LA 4350.01)

AAMI/ANSI/ISO 11737-2; USP <71>; AAMI/ANSI/ISO 11737-1; AAMI ST72; USP <85>; <161>; 11737-3; ISO 10993-5; ISO 10993-7; USP <643>

ISO 10993-7Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
As written on the certificate · Line 2 (A2LA 4350.03)

AAMI/ANSI/ISO 11737-2; USP <71>; AAMI/ANSI/ISO 11737-1; AAMI ST72; USP <85>; <161>; 11737-3; ISO 10993-5; ISO 10993-7; USP <643>

As written on the certificate · Line 2 (A2LA 4350.01)

AAMI/ANSI/ISO 11737-2; USP <71>; AAMI/ANSI/ISO 11737-1; AAMI ST72; USP <85>; <161>; 11737-3; ISO 10993-5; ISO 10993-7; USP <643>

ISO 11737-1Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
As written on the certificate · Line 2 (A2LA 4350.03)

AAMI/ANSI/ISO 11737-2; USP <71>; AAMI/ANSI/ISO 11737-1; AAMI ST72; USP <85>; <161>; 11737-3; ISO 10993-5; ISO 10993-7; USP <643>

As written on the certificate · Line 2 (A2LA 4350.01)

AAMI/ANSI/ISO 11737-2; USP <71>; AAMI/ANSI/ISO 11737-1; AAMI ST72; USP <85>; <161>; 11737-3; ISO 10993-5; ISO 10993-7; USP <643>

ISO 11737-2Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
As written on the certificate · Line 2 (A2LA 4350.03)

AAMI/ANSI/ISO 11737-2; USP <71>; AAMI/ANSI/ISO 11737-1; AAMI ST72; USP <85>; <161>; 11737-3; ISO 10993-5; ISO 10993-7; USP <643>

As written on the certificate · Line 2 (A2LA 4350.01)

AAMI/ANSI/ISO 11737-2; USP <71>; AAMI/ANSI/ISO 11737-1; AAMI ST72; USP <85>; <161>; 11737-3; ISO 10993-5; ISO 10993-7; USP <643>

ISO 14698-1Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods
As written on the certificate · Line 1 (A2LA 4350.03)

ISO/IEC 17025:2017; USP <51>; ISO 14698-1; USP <61>; USP <62>; Standard Methods for the Examination of Water and Wastewater

As written on the certificate · Line 1 (A2LA 4350.01)

ISO/IEC 17025:2017; USP <51>; ISO 14698-1; USP <61>; USP <62>; Standard Methods for the Examination of Water and Wastewater

Scope as published by A2LA

6 lines
A2LA

ISO/IEC 17025

Active

4350.01

The scope document we hold says it is valid until 2027-01-31.

View scope

Accredited scope, certificate 4350.01

LineDisciplineMethodMatrixRange
1biologicalISO/IEC 17025:2017; USP <51>; ISO 14698-1; USP <61>; USP <62>; Standard Methods for the Examination of Water and Wastewatermedical devices, environmental samples, and cosmetics-
2biologicalAAMI/ANSI/ISO 11737-2; USP <71>; AAMI/ANSI/ISO 11737-1; AAMI ST72; USP <85>; <161>; 11737-3; ISO 10993-5; ISO 10993-7; USP <643>--
3biological
For the tests to which this accreditation applies, please refer to the laboratory’s Biological Scope of Accreditation. Accredited Laboratory A2LA has accredited STERIS LABORATORIES, INC. Brooklyn Park, MN 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 18th day of November 2024. _______________________ Mr. Trace McInturff, Vice President, Accreditation Services For the Accreditation Council Certificate Number 4350.01 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.

A2LA

ISO/IEC 17025

Active

4350.03

The scope document we hold says it is valid until 2027-01-31.

View scope

Accredited scope, certificate 4350.03

LineDisciplineMethodMatrixRange
1biologicalISO/IEC 17025:2017; USP <51>; ISO 14698-1; USP <61>; USP <62>; Standard Methods for the Examination of Water and WastewaterMedical devices-
2biologicalAAMI/ANSI/ISO 11737-2; USP <71>; AAMI/ANSI/ISO 11737-1; AAMI ST72; USP <85>; <161>; 11737-3; ISO 10993-5; ISO 10993-7; USP <643>--
3biological
For the tests to which this accreditation applies, please refer to the laboratory’s Biological Scope of Accreditation. Accredited Laboratory A2LA has accredited STERIS LABORATORIES, INC. Brooklyn Park, MN 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 18th day of November 2024. _______________________ Mr. Trace McInturff, Vice President, Accreditation Services For the Accreditation Council Certificate Number 4350.01 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.

Location

9303 West Broadway Ave., Brooklyn Park, MN, 55445, US

45.10048, -93.34436

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Other Locations

1 other site in this organization

Libertyville, IL, US
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