United States

DDL, Inc. - DDL CA

DDL CA, 9400 Toledo Way, 92618, Irvine, CA, United States

A2LA|3561.02ISO/IEC 17025Register refreshed 2026-09-25

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suzette.glennon@ddltesting.com

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A2LARefreshed 2026-09-25: 3561.02Active

Accredited standards

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 D642Name not checked yet

As written on the certificate · Line 6 (A2LA 3561.02)

ASTM D999; ASTM D642; ASTM D7386; ISTA 1B; ISTA 2B; ISTA 1A; ISTA 2A; ISTA 1C; ISTA 1D; ISTA 1E; ISTA 1G; ISTA 1H; ISTA 3A; ISTA 3B; ISTA 3E; ISTA 3F; ISTA 6-FEDEX-A; ISTA- 6 FEDEX - B; ISTA 7D; ISTA 6 Amazon SIOC; ISTA-6 Amazon Over Boxing; ASTM D4332; ASTM F2825; ASTM F1980

ASTM D999Name not checked yet

As written on the certificate · Line 5 (A2LA 3561.02)

ISO 9626; ISO 594-1; ISO 594-2; ISO 23908; ASTM F1929; ASTM F3039; ASTM F2096; ASTM F1140; ASTM F1886; ASTM F88; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999

As written on the certificate · Line 6 (A2LA 3561.02)

ASTM D4169Name not checked yet

As written on the certificate · Line 5 (A2LA 3561.02)

ISO 9626; ISO 594-1; ISO 594-2; ISO 23908; ASTM F1929; ASTM F3039; ASTM F2096; ASTM F1140; ASTM F1886; ASTM F88; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999

ASTM D4332Name not checked yet

As written on the certificate · Line 6 (A2LA 3561.02)

ASTM D4728Name not checked yet

As written on the certificate · Line 5 (A2LA 3561.02)

ISO 9626; ISO 594-1; ISO 594-2; ISO 23908; ASTM F1929; ASTM F3039; ASTM F2096; ASTM F1140; ASTM F1886; ASTM F88; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999

ASTM D5265Name not checked yet

As written on the certificate · Line 5 (A2LA 3561.02)

ISO 9626; ISO 594-1; ISO 594-2; ISO 23908; ASTM F1929; ASTM F3039; ASTM F2096; ASTM F1140; ASTM F1886; ASTM F88; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999

ASTM D5276Name not checked yet

As written on the certificate · Line 5 (A2LA 3561.02)

ISO 9626; ISO 594-1; ISO 594-2; ISO 23908; ASTM F1929; ASTM F3039; ASTM F2096; ASTM F1140; ASTM F1886; ASTM F88; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999

ASTM D6344Name not checked yet

As written on the certificate · Line 5 (A2LA 3561.02)

ISO 9626; ISO 594-1; ISO 594-2; ISO 23908; ASTM F1929; ASTM F3039; ASTM F2096; ASTM F1140; ASTM F1886; ASTM F88; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999

ASTM D6653Name not checked yet

As written on the certificate · Line 5 (A2LA 3561.02)

ISO 9626; ISO 594-1; ISO 594-2; ISO 23908; ASTM F1929; ASTM F3039; ASTM F2096; ASTM F1140; ASTM F1886; ASTM F88; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999

ASTM D7386Name not checked yet

As written on the certificate · Line 6 (A2LA 3561.02)

ASTM F88Name not checked yet

As written on the certificate · Line 5 (A2LA 3561.02)

ISO 9626; ISO 594-1; ISO 594-2; ISO 23908; ASTM F1929; ASTM F3039; ASTM F2096; ASTM F1140; ASTM F1886; ASTM F88; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999

ASTM F1140Name not checked yet

As written on the certificate · Line 5 (A2LA 3561.02)

ISO 9626; ISO 594-1; ISO 594-2; ISO 23908; ASTM F1929; ASTM F3039; ASTM F2096; ASTM F1140; ASTM F1886; ASTM F88; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999

ASTM F1886Name not checked yet

As written on the certificate · Line 5 (A2LA 3561.02)

ISO 9626; ISO 594-1; ISO 594-2; ISO 23908; ASTM F1929; ASTM F3039; ASTM F2096; ASTM F1140; ASTM F1886; ASTM F88; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999

ASTM F1929Name not checked yet

As written on the certificate · Line 5 (A2LA 3561.02)

ISO 9626; ISO 594-1; ISO 594-2; ISO 23908; ASTM F1929; ASTM F3039; ASTM F2096; ASTM F1140; ASTM F1886; ASTM F88; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999

ASTM F1980Name not checked yet

As written on the certificate · Line 6 (A2LA 3561.02)

ASTM F2096Name not checked yet

As written on the certificate · Line 5 (A2LA 3561.02)

ISO 9626; ISO 594-1; ISO 594-2; ISO 23908; ASTM F1929; ASTM F3039; ASTM F2096; ASTM F1140; ASTM F1886; ASTM F88; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999

ASTM F2825Name not checked yet

As written on the certificate · Line 6 (A2LA 3561.02)

ASTM F3039Name not checked yet

As written on the certificate · Line 5 (A2LA 3561.02)

ISO 9626; ISO 594-1; ISO 594-2; ISO 23908; ASTM F1929; ASTM F3039; ASTM F2096; ASTM F1140; ASTM F1886; ASTM F88; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999

ISO

ISO 594-1Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements

As written on the certificate · Line 5 (A2LA 3561.02)

ISO 9626; ISO 594-1; ISO 594-2; ISO 23908; ASTM F1929; ASTM F3039; ASTM F2096; ASTM F1140; ASTM F1886; ASTM F88; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999

ISO 594-2Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings

As written on the certificate · Line 5 (A2LA 3561.02)

ISO 9626; ISO 594-1; ISO 594-2; ISO 23908; ASTM F1929; ASTM F3039; ASTM F2096; ASTM F1140; ASTM F1886; ASTM F88; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999

ISO 7864Sterile hypodermic needles for single use - Requirements and test methods

As written on the certificate · Line 2 (A2LA 3561.02)

ISO 11040-4; ISO 11040-6; ISO 11040-8; ISO 11608-1; ISO 10555-1; ISO 7864

ISO 7886-1Sterile hypodermic syringes for single use - Part 1: Syringes for manual use

As written on the certificate · Line 3 (A2LA 3561.02)

ISO 7886-1; ISO 11070; ISO 8536-4; ISO 8536-8

ISO 9626Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods

As written on the certificate · Line 5 (A2LA 3561.02)

ISO 9626; ISO 594-1; ISO 594-2; ISO 23908; ASTM F1929; ASTM F3039; ASTM F2096; ASTM F1140; ASTM F1886; ASTM F88; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999

ISO 10555-1Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements

As written on the certificate · Line 2 (A2LA 3561.02)

ISO 11040-4; ISO 11040-6; ISO 11040-8; ISO 11608-1; ISO 10555-1; ISO 7864

ISO 11070Sterile single-use intravascular introducers, dilators and guidewires

As written on the certificate · Line 3 (A2LA 3561.02)

ISO 7886-1; ISO 11070; ISO 8536-4; ISO 8536-8

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 3561.02)

ISO 11040-4; ISO 11040-6; ISO 11040-8; ISO 11608-1; ISO 10555-1; ISO 7864

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 5 (A2LA 3561.02)

ISO 9626; ISO 594-1; ISO 594-2; ISO 23908; ASTM F1929; ASTM F3039; ASTM F2096; ASTM F1140; ASTM F1886; ASTM F88; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999

ISO 80369-20Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods

As written on the certificate · Line 1 (A2LA 3561.02)

ISO/IEC 17025:2017; ISO 80369-20; ISO 11040-4; ISO 11040-6

ISO 8536 series

ISO 8536-4Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed

As written on the certificate · Line 3 (A2LA 3561.02)

ISO 7886-1; ISO 11070; ISO 8536-4; ISO 8536-8

ISO 8536-8Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus

As written on the certificate · Line 3 (A2LA 3561.02)

ISO 7886-1; ISO 11070; ISO 8536-4; ISO 8536-8

ISO 8536-9Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment

As written on the certificate · Line 4 (A2LA 3561.02)

ISO 8536-9; ISO 8536-10; ISO 8536-11; ISO 8536-12; ISO 8536-13; ISO 8536-14

ISO 8536-10Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment

As written on the certificate · Line 4 (A2LA 3561.02)

ISO 8536-9; ISO 8536-10; ISO 8536-11; ISO 8536-12; ISO 8536-13; ISO 8536-14

ISO 8536-11Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment

As written on the certificate · Line 4 (A2LA 3561.02)

ISO 8536-9; ISO 8536-10; ISO 8536-11; ISO 8536-12; ISO 8536-13; ISO 8536-14

ISO 8536-12Infusion equipment for medical use - Part 12: Check valves for single use

As written on the certificate · Line 4 (A2LA 3561.02)

ISO 8536-9; ISO 8536-10; ISO 8536-11; ISO 8536-12; ISO 8536-13; ISO 8536-14

ISO 8536-13Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact

As written on the certificate · Line 4 (A2LA 3561.02)

ISO 8536-9; ISO 8536-10; ISO 8536-11; ISO 8536-12; ISO 8536-13; ISO 8536-14

ISO 8536-14Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact

As written on the certificate · Line 4 (A2LA 3561.02)

ISO 8536-9; ISO 8536-10; ISO 8536-11; ISO 8536-12; ISO 8536-13; ISO 8536-14

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 3561.02)

ISO/IEC 17025:2017; ISO 80369-20; ISO 11040-4; ISO 11040-6

As written on the certificate · Line 2 (A2LA 3561.02)

ISO 11040-4; ISO 11040-6; ISO 11040-8; ISO 11608-1; ISO 10555-1; ISO 7864

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 3561.02)

ISO/IEC 17025:2017; ISO 80369-20; ISO 11040-4; ISO 11040-6

As written on the certificate · Line 2 (A2LA 3561.02)

ISO 11040-4; ISO 11040-6; ISO 11040-8; ISO 11608-1; ISO 10555-1; ISO 7864

ISO 11040-8Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes

As written on the certificate · Line 2 (A2LA 3561.02)

ISO 11040-4; ISO 11040-6; ISO 11040-8; ISO 11608-1; ISO 10555-1; ISO 7864

Scope as published by A2LA

7 lines

A2LA

ISO/IEC 17025

Active

3561.02

The scope document we hold says it is valid until 2027-05-31.

View scope

Accredited scope, certificate 3561.02

Line	Discipline	Method	Matrix	Range
1	mechanical	ISO/IEC 17025:2017; ISO 80369-20; ISO 11040-4; ISO 11040-6	Medical devices	0 to 360 °
2	mechanical	ISO 11040-4; ISO 11040-6; ISO 11040-8; ISO 11608-1; ISO 10555-1; ISO 7864	Prefilled Syringes – Glass and Plastic Barrels for Injectables and Sterilized Subassembled Syringes Ready for Filling & Finished Prefilled Syringes; Needle –Base Injection Systems for Medical Use Requirements and Test Methods Part 1: Needle Based Injection Systems; Intravascular Catheters – Sterile and Single-use Catheters – Part 1: General Requirements; Sterile Hypodermic Needles for Single Use – Requirements and Test Methods	-
3	mechanical	ISO 7886-1; ISO 11070; ISO 8536-4; ISO 8536-8	Sterile Hypodermic Syringes for Single Use – Syringes for Manual Use; Sterile Single Use Intravascular Introducers, Dilators, and Guidewires; Infusion Equipment for Medical Use – Part 4: Infusion Sets for Single Use, Gravity Feed; Infusion Equipment for Medical Use – Part 8: Infusion Sets for Single Use with Pressure Infusion Equipment	-
4	mechanical	ISO 8536-9; ISO 8536-10; ISO 8536-11; ISO 8536-12; ISO 8536-13; ISO 8536-14	Infusion Equipment for Medical Use	-
5	mechanical	ISO 9626; ISO 594-1; ISO 594-2; ISO 23908; ASTM F1929; ASTM F3039; ASTM F2096; ASTM F1140; ASTM F1886; ASTM F88; ASTM D4169; ASTM D6653; ASTM D5276; ASTM D6344; ASTM D5265; ASTM D4728; ASTM D999	Stainless Steel Needle Tubing for the Manufacture of Medical Devices; Medical Connectors	-
6	mechanical	ASTM D999; ASTM D642; ASTM D7386; ISTA 1B; ISTA 2B; ISTA 1A; ISTA 2A; ISTA 1C; ISTA 1D; ISTA 1E; ISTA 1G; ISTA 1H; ISTA 3A; ISTA 3B; ISTA 3E; ISTA 3F; ISTA 6-FEDEX-A; ISTA- 6 FEDEX - B; ISTA 7D; ISTA 6 Amazon SIOC; ISTA-6 Amazon Over Boxing; ASTM D4332; ASTM F2825; ASTM F1980	Packages or Packaging Components	-45 to 100 °C
7	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 DDL, INC. – DDL CA Irvine, CA 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 24th day of February 2025. _______________________ Mr. Trace McInturff, Vice President, Accreditation Services For the Accreditation Council Certificate Number 3561.02 Valid to May 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

DDL CA, 9400 Toledo Way, Irvine, CA, 92618, US

33.68570, -117.82598

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Accreditation data refreshed from the A2LA register on 2026-09-25.

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