ISO 11608-1 Accredited Testing Labs Worldwide

Part of a series

See all 10 labs worldwide for ISO 11608 (any part)

Part 1 (Needle-based injection systems): 8 labs · Part 2 (Double-ended pen needles): 1 lab · Part 3 (Containers and integrated fluid paths): 1 lab · Part 4: 3 labs · Part 5 (Automated functions): 1 lab

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8 accredited laboratories in 3 countries hold ISO 11608-1 in their ISO/IEC 17025 scope. Primary accreditors include American Association for Laboratory Accreditation.

Total labs

Countries

Available in 3 Countries

United States

5 labs

United Kingdom

2 labs

Germany

1 lab

Top matrices for ISO 11608-1

Air

2 labs

Sample labs

Medical Engineering Technologies

Dover, GB

ISO 11608-1:2022 Air transport simulation IHM WI 54 October 2024 Break loose & Glide force IHM WI 52 May 2022 based on ISO 11040-8:2016 Clause:6.2 Needle cap removal force IHM WI 52 May 2022 based on ISO 11040-4:2016 G6

Endolab Mechanical Engineering

Riedering, DE

ISO 11608-1:2022-09 Kanülenbasierte Injektio nssysteme zur medizinischen Verwendung – Anforderungen und Prüfverfahren – Teil 1: Kanülenbasierte Injektionssysteme (ISO 11608-1:2022)

DDL, Inc. - DDL CA

Irvine, CA, US

ISO 11608-1 Environmental Conditioning Free Fall Testing Vibration Testing Dose Accuracy Intravascular Catheters – Sterile and Single-use Catheters – Part 1: General Requirements ISO 10555-1 Corrosion Resistance Peak Tensi

Smithers MDT

Shropshire, GB

ISO 11608-1:2015 BS EN ISO 11608-1:2022 Syringes Plunger operation force BS EN ISO 7886-1:2018 (Annex E) Small bore connectors Fluid Leakage ISO 80369-7:2021 and ISO 80369-20:2024 Sub-atmostpheric pressure air leakage I

DDL, Inc.

Eden Prairie, MN, US

ISO 11608-1 Environmental Conditioning Free Fall Testing Vibration Testing Dose Accuracy Sharps Injury Protection – Requirements and Test Methods – Sharps Protection Features for Single-use Hypodermic Needles, Introducers for

TUV SUD America

San Diego, CA, US

ISO 11608-1 (Section 11); CISPR 24 (2010+C1:2011+A1:2015, 2015) ; EN 50130-4; EN 55020

Eurofins Lancaster

Lancaster, PA, US

ISO 11608-1 Cartridge Holder Removal Force of Pen- or Auto- Injectors (Axial Load) ISO 11608-1 Dose Accuracy of Pen- or Auto-Injectors ISO 11608-1 Drop Testing of Pen- or Auto-Injectors ISO 11608-1 Injection Force Activation for Pen-

DDL MN2

Minnetonka, MN, US

ISO 11608-1 Temperature and Humidity Temperature Range: -45 C to 120 C Humidity Range: RH 10% to 95% ASTM F1980; ASTM F2825; ASTM D618; ASTM D4332 Distribution Testing ASTM D4169 Altitude ASTM D6653 Drops ASTM D5276

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