Services	- Medical Services

Electrical Safety for Medical Equipment

As a European Union Notified Body, an SCC-accredited Certification Body for Canada, and an NRTL (Nationally Recognized Testing Laboratory) for the United States, TÜV SÜD Canada provides electrical safety services for medical electrical equipment helping manufacturers demonstrate compliance to international standards.

TÜV SÜD's services include:

MDD Directive 93/42/EEC: European Union Medical Device Directive
EN/IEC 60601-1: Medical Electrical Equipment - General Requirements for Safety
FDA 510(K) Approval: Class I and Class II Medical Devices Pre-Market Requirements
EMC IEC 601-1-1-2:2001: Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard - Electromagnetic Compatibility - Requirements and Tests.
CHINA (CCC): Safety and quality compliance mark for China
CAN/CSA C22.2 NO. 601.1-M90 : Medical Electrical Equipment - General Requirements for Safety
UL/ANSI 60601-1:2001: Medical Electrical Equipment, Part 1 General Requirements for Safety
And more.

Additionally, TÜV SÜD Canada is also a member of the international CB Scheme. TÜV SÜD test reports are recognized by all members of the international CB Scheme, lowering your testing costs by utilizing TÜV SÜD test reports, and gaining certification from other CB members.

NRTL Services
TÜV SÜD Canada Inc. and TÜV SÜD Product Service GmbH are recognized NRTL's (Nationally Recognized Testing Laboratories) providing electrical safety testing to US standards. As an NRTL, TÜV SÜD Canada can perform electrical safety testing to a variety of UL/ANSI standards including UL/ANSI 2601, UL/ANSI 60601-1 and many more. (Click here to view the full scope of our NRTL accreditation.)

In addition, TÜV SÜD Product Service is an Standards Council of Canada (SCC)-accredited Certification Body able to perform electrical safety testing to Canadian requirements.

For more information, contact us.

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