Laboratory Equipment and Laboratory Products
Safety and Reliability – a Convincing Sales Argument
Laboratory equipment, laboratory machines, measuring and control devices as well as in vitro diagnostic devices are as diverse as the fields in which they are used. However, they have one thing in common: They must be safe in all applications and provide reliable results. Whether in product development in industry or in the analysis of human samples and making binding diagnoses in medicine. The safety and reliability of the products is an important sales factor.
Use our certifications to show that your products are safe and user-friendly and meet the high legal requirements in various markets all over the world. We test for safety and reliability and evaluate technology, function, material and design for all global markets. We consider the applicable standards and guidelines and support you as a strong partner through all phases, from development to testing and certification.
Benefit from out comprehensive services as a manufacturer of laboratory equipment, laboratory machines, measuring and control devices, in vitro diagnostic devices or laser devices. For example, we carry out tests in accordance with the international standards IEC 61010-1 and IEC 61010-2-ff (e.g. 61010-2-101) and their country-specific requirements and support you when entering new markets. Save time and costs for a successful market launch thanks to our global network and expertise.
Testing and Certification for Germany and Europe
CE marking
Our experts test your products in accordance with the relevant EU regulations, such as the Low Voltage Directive (LVD) or the Electromagnetic Compatibility Directive (EMC). With a CE declaration of conformity (self-declaration of the manufacturer), your products are ready for the European market.
Entering International Markets
Other countries – other rules. International market access becomes more difficult due to many individual approval regulations, directives and rules. Take advantage of the expertise of TÜV Rheinland's global network of experts. With our international product certifications and registrations, we support you in entering new markets. We are at your side with help and advice right from the start. If required, we can support you from the development phase of your product to uncomplicated and successful certification. TÜV Rheinland is familiar with the various approval requirements on international markets and takes care of the necessary tests.
CB scheme
The CB scheme is an internationally recognized testing program that facilitates access to the world's major markets for manufacturers. If you successfully pass the test, you can prove the safety of your electrical products in 50 countries around the world. The experts at TÜV Rheinland will test your products and support you with the subsequent international product approval.
TÜV Rheinland – Internationally Recognized Certification Body for Worldwide Support
As experts in the testing and certification of various standards and directives, we are very familiar with the individual challenges of international markets. We can therefore provide you with excellent support in the following markets:
- USA and Canada: TÜV Rheinland has been active in these markets for many years and is approved by OSHA and SCC as a Nationally Recognized Testing Laboratory (NRTL). In the USA and Canada, certifications in accordance with cTUVus and the CB procedure are relevant.
- United Kingdom (UK): TÜV Rheinland is a UK Approved Body and certifies according to UKCA and UKNI (Ireland), as well as other standards.
- India: A TÜV Rheinland specialist team is on site in India for BIS certification. We also carry out tests for devices with a radio interface in accordance with Wireless Planning and Coordination (WPC).
- China: TÜV Rheinland is represented in China at over 20 locations with more than 90 laboratories. This is important because product tests must be carried out in a recognized test laboratory in China. Certain RoHS requirements must be met and devices with a radio interface must be recognized in accordance with SRRC.
- South Korea: The TÜV Rheinland locations in Japan, Germany, Hungary, USA, Taiwan, Turkey, India, Italy and France are recognized as KTL (Korean Testing Laboratory) in South Korea. Among other things, our experts test according to the Korean Safety Requirements (KC), including KC RRA (for laboratory devices with radio technology). Some of the testing for this standard must be carried out in South Korea.
- Australia and New Zealand: TÜV Rheinland supports you in Australia and New Zealand by testing the standards required to get the RCM label.
New Sales Market: Your Product for the Medical Sector
Manufacturers of laboratory equipment can have their products tested in accordance with the IEC 61010-2-101 standard to access a completely new sales market – the in vitro diagnostics market. With a predicted annual growth rate of 2.68%, this market offers enormous potential. Devices for the industrial sector can qualify for use in the medical sector by being tested in accordance with IEC 61010-2-101.
What are the IEC 61010-1 and IEC 61010-2-101 standards about?
Irrespective of whether they are used in the laboratory, in industry or in the medical sector, laboratory equipment, measuring and control devices, laboratory machines and in vitro diagnostic devices must be tested in accordance with the international IEC 61010-1 series of standards.
The basic standard IEC 61010-1 contains general specifications on safety as well as requirements for the product and documentation. The tests include protection against electric shock, mechanical hazards and the spread of fire. Should measuring, control and laboratory devices developed for use in industry also be used in the medical sector?
In this case, the standard IEC 61010-2-101 “Particular requirements for in vitro diagnostic (IVD) medical devices” becomes relevant. IVDs include products that come into contact with a sample (e.g. blood, saliva or urine). If the products meet the requirements of the standard, they can be marketed internationally as in vitro diagnostics. It may also be necessary to test computers or software in accordance with IEC 61010-2-101 if they are part of a device that is subject to the standard or has been developed for use with such devices. TÜV Rheinland is familiar with both standards and will be happy to assist you with testing.
While no Notified Body needs to be involved in the certification of medical laboratory equipment according to the In Vitro Diagnostic Regulation (IVDR), this is necessary for testing. As a Notified Body, TÜV Rheinland provides you with competent support. Our experts will personally assist you throughout the entire audit process.
GS Mark and Certification Process
The GS mark requires a high level of testing that goes beyond the basic requirements for CE marking (self-declaration of the manufacturer). Our experts carry out tests for electrical safety, electromagnetic compatibility and functional safety that comply with the relevant national and international directives and standards. At the end, you receive a report, and we issue the GS mark. If necessary, the product safety must first be improved by the manufacturer before the mark can be conferred.
In order for you to retain the GS mark, the law requires regular inspection/testing of the production facility. This ensures that production is continuously monitored. You must inform us in advance of any changes to the product, otherwise the certificate will lose its validity.
You can find detailed information on GS certification here.
Your Benefits at a Glance
With the independent testing of your laboratory equipment, laboratory machines, measuring and control devices and in vitro diagnostics by specialist teams from TÜV Rheinland
- your products meet all legal safety requirements.
- you can document that your product meets the highest standards of ergonomics, operational safety, and usability.
- you improve your market position and increase your sales.
- you gain access to the fast-growing in vitro diagnostics market.
- you increase the trust in the quality of your products.
- you strengthen customer loyalty and profit from follow-up purchases.
- you have a strong partner at your side who supports you personally throughout the entire process.
- you can rely on a fast process so that you reach your goal quickly.
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