IEC 60601-1 Testing and Certification

We support you in the testing and certification of your medical devices and systems according to national and international standards and regulations, e.g. by application of IEC 60601 series

Our Accreditations

IEC 60601-1:2020 (ed. 3.2) – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

Tests according to the IEC/EN 60601/80601 series of standards for active medical devices and systems, taking into account national deviations and special features

Testing for devices intended to operate in the emergency service environment, such as in ambulances, helicopters, or aircraft (IEC 60601-1-12, EN 1789, EN 13718, RTCA DO-160G)

Testing programs for medical devices in domestic use (IEC 60601-1-11)

Gap analysis program for IEC 60601-1:2020 Amendment 2

You Need Pre-Compliance Evaluation – here’s why

Pre-compliance testing is a valuable tool for product development, as it allows you to proactively identify potential failures

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FDA Medical Device Material Performance Requirements – Guide

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IEC 60601-1: Everything You Need to Know

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Contact Us:

020 3813 0969 info@testlabsuk.com

Explore our medical device testing services

IEC 60601-1-2 EMC Testing

We offer EMC test program for active medical devices and/or systems, which defines emission and immunity criteria per IEC 60601-1-2

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Pre-compliance IEC 60601-1 Testing

We test your device, mitigating the cost of repeated compliance testing by evaluating potential non- compliances.

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Material compatibility assessment

We analyse test item materials at both sample and product level to assess process compatibility

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See our research & testing facilities

Microbiology Laboratory

We are fully equipped to perform a wide variety of microbiology tests using bacteria, yeast, fungi, and bacterial spores.

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Test Chambers

We have built state of the art Test Chambers – all with a stainless steel interior and equipped with a wide range of sensors.

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Chemistry Laboratory

Our chemistry lab is fully equipped to perform a wide variety of tests, that supports formulation and materials development.

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Strong foundations are built with robust Quality Management Systems

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