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United States

DDL MN2

5407 Opportunity Court Minnetonka MN 55343, 55343, Minnetonka, MN, United States

A2LA|3561.04ISO/IEC 17025Register refreshed 2026-09-25
Certificates
1
Scope items
3
Standards
18
Locations
1

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Register record

A2LARefreshed
3561.04Active

Accredited standards

18

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.

ASTM

ASTM D618Name not checked yet
As written on the certificate · Line 2 (A2LA 3561.04)

ISO 23908; ISO 11608-1; ASTM F1980; ASTM F2825; ASTM D618; ASTM D4332; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999; ASTM D642; ASTM D7386; ISTA 1A; ISTA 1C; ISTA 1G; ISTA 2A; ISTA 3A; ISTA 3F

ASTM D642Name not checked yet
As written on the certificate · Line 2 (A2LA 3561.04)

ISO 23908; ISO 11608-1; ASTM F1980; ASTM F2825; ASTM D618; ASTM D4332; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999; ASTM D642; ASTM D7386; ISTA 1A; ISTA 1C; ISTA 1G; ISTA 2A; ISTA 3A; ISTA 3F

ASTM D999Name not checked yet
As written on the certificate · Line 2 (A2LA 3561.04)

ISO 23908; ISO 11608-1; ASTM F1980; ASTM F2825; ASTM D618; ASTM D4332; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999; ASTM D642; ASTM D7386; ISTA 1A; ISTA 1C; ISTA 1G; ISTA 2A; ISTA 3A; ISTA 3F

ASTM D4169Name not checked yet
As written on the certificate · Line 2 (A2LA 3561.04)

ISO 23908; ISO 11608-1; ASTM F1980; ASTM F2825; ASTM D618; ASTM D4332; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999; ASTM D642; ASTM D7386; ISTA 1A; ISTA 1C; ISTA 1G; ISTA 2A; ISTA 3A; ISTA 3F

ASTM D4332Name not checked yet
As written on the certificate · Line 2 (A2LA 3561.04)

ISO 23908; ISO 11608-1; ASTM F1980; ASTM F2825; ASTM D618; ASTM D4332; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999; ASTM D642; ASTM D7386; ISTA 1A; ISTA 1C; ISTA 1G; ISTA 2A; ISTA 3A; ISTA 3F

ASTM D4728Name not checked yet
As written on the certificate · Line 2 (A2LA 3561.04)

ISO 23908; ISO 11608-1; ASTM F1980; ASTM F2825; ASTM D618; ASTM D4332; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999; ASTM D642; ASTM D7386; ISTA 1A; ISTA 1C; ISTA 1G; ISTA 2A; ISTA 3A; ISTA 3F

ASTM D5265Name not checked yet
As written on the certificate · Line 2 (A2LA 3561.04)

ISO 23908; ISO 11608-1; ASTM F1980; ASTM F2825; ASTM D618; ASTM D4332; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999; ASTM D642; ASTM D7386; ISTA 1A; ISTA 1C; ISTA 1G; ISTA 2A; ISTA 3A; ISTA 3F

ASTM D5276Name not checked yet
As written on the certificate · Line 2 (A2LA 3561.04)

ISO 23908; ISO 11608-1; ASTM F1980; ASTM F2825; ASTM D618; ASTM D4332; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999; ASTM D642; ASTM D7386; ISTA 1A; ISTA 1C; ISTA 1G; ISTA 2A; ISTA 3A; ISTA 3F

ASTM D6344Name not checked yet
As written on the certificate · Line 2 (A2LA 3561.04)

ISO 23908; ISO 11608-1; ASTM F1980; ASTM F2825; ASTM D618; ASTM D4332; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999; ASTM D642; ASTM D7386; ISTA 1A; ISTA 1C; ISTA 1G; ISTA 2A; ISTA 3A; ISTA 3F

ASTM D6653Name not checked yet
As written on the certificate · Line 2 (A2LA 3561.04)

ISO 23908; ISO 11608-1; ASTM F1980; ASTM F2825; ASTM D618; ASTM D4332; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999; ASTM D642; ASTM D7386; ISTA 1A; ISTA 1C; ISTA 1G; ISTA 2A; ISTA 3A; ISTA 3F

ASTM D7386Name not checked yet
As written on the certificate · Line 2 (A2LA 3561.04)

ISO 23908; ISO 11608-1; ASTM F1980; ASTM F2825; ASTM D618; ASTM D4332; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999; ASTM D642; ASTM D7386; ISTA 1A; ISTA 1C; ISTA 1G; ISTA 2A; ISTA 3A; ISTA 3F

ASTM F1980Name not checked yet
As written on the certificate · Line 2 (A2LA 3561.04)

ISO 23908; ISO 11608-1; ASTM F1980; ASTM F2825; ASTM D618; ASTM D4332; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999; ASTM D642; ASTM D7386; ISTA 1A; ISTA 1C; ISTA 1G; ISTA 2A; ISTA 3A; ISTA 3F

ASTM F2825Name not checked yet
As written on the certificate · Line 2 (A2LA 3561.04)

ISO 23908; ISO 11608-1; ASTM F1980; ASTM F2825; ASTM D618; ASTM D4332; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999; ASTM D642; ASTM D7386; ISTA 1A; ISTA 1C; ISTA 1G; ISTA 2A; ISTA 3A; ISTA 3F

ISO 11040 series

ISO 11040-4Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
As written on the certificate · Line 1 (A2LA 3561.04)

ISO 11040-4; ISO 11040-6; ISO 11040-8

ISO 11040-6Prefilled syringes - Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling
As written on the certificate · Line 1 (A2LA 3561.04)

ISO 11040-4; ISO 11040-6; ISO 11040-8

ISO 11040-8Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes
As written on the certificate · Line 1 (A2LA 3561.04)

ISO 11040-4; ISO 11040-6; ISO 11040-8

Other standards

ISO 11608-1Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
As written on the certificate · Line 2 (A2LA 3561.04)

ISO 23908; ISO 11608-1; ASTM F1980; ASTM F2825; ASTM D618; ASTM D4332; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999; ASTM D642; ASTM D7386; ISTA 1A; ISTA 1C; ISTA 1G; ISTA 2A; ISTA 3A; ISTA 3F

ISO 23908Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration - Requirements and test methods
As written on the certificate · Line 2 (A2LA 3561.04)

ISO 23908; ISO 11608-1; ASTM F1980; ASTM F2825; ASTM D618; ASTM D4332; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999; ASTM D642; ASTM D7386; ISTA 1A; ISTA 1C; ISTA 1G; ISTA 2A; ISTA 3A; ISTA 3F

Scope as published by A2LA

3 lines
A2LA

ISO/IEC 17025

Active

3561.04

The scope document we hold says it is valid until 2027-03-31.

View scope

Accredited scope, certificate 3561.04

LineDisciplineMethodMatrixRange
1mechanicalISO 11040-4; ISO 11040-6; ISO 11040-8Prefilled Syringes – Glass and Plastic Barrels for Injectables and Sterilized Subassembled Syringes ready for Filling; Prefilled Syringes – Glass and Plastic Barrels for Injectables and Sterilized Subassembled Syringes Ready for Filling and Finished Prefilled Syringes; Prefilled Syringes – Requirements and Test Methods for Finished Prefilled Syringes-
2mechanicalISO 23908; ISO 11608-1; ASTM F1980; ASTM F2825; ASTM D618; ASTM D4332; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999; ASTM D642; ASTM D7386; ISTA 1A; ISTA 1C; ISTA 1G; ISTA 2A; ISTA 3A; ISTA 3F--45 to 120 C
3mechanical---

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

5407 Opportunity Court Minnetonka MN 55343, Minnetonka, MN, 55343, US

44.94051, -93.46389

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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.