Measuring, control, and laboratory equipment, as well as products for in vitro diagnostics (ivd)

For the marketing of laboratory, measuring and control equipment in the EU, CE marking is mandatory. In addition, the essential requirements for each product must be evaluated and documented, for instance in accordance with the Low Voltage Directive 2014/35/EU and the EMC Directive 2014/30/EU. Other overlapping directives and regulations such as RED (radio), the Machinery Directive, or Medical Device / IVD Regulation may be applicable.

SGS supports you in testing and certifying your equipment and systems according to national and international standards and regulations. With our many years of experience and a broad international network of testing laboratories and certification bodies, we offer solutions for your products from a single source. With its laboratories in Munich and around the world, SGS supports you in meeting all the requirements. Our accreditations according to DIN EN ISO/IEC 17025:2018 by DAkkS are also internationally recognized by the ILAC (International Laboratory Accreditation Cooperation).

In addition, we are accredited by the IEC as a CBTL (CB Test Laboratory). This means we can offer you the opportunity to participate in the IECEE CB procedure (CB scheme). Testing and certification of your products through the CB procedure allows you to gain easier access to approximately 56 member countries.

SGS is a Nationally Recognized Test Laboratory (NRTL) for certification based on American standards. In addition, SGS is accredited by the SCC (Standards Council of Canada) to carry out the tests according to Canadian standards and thus to issue the relevant joint approval mark for the USA and Canada.

SGS accompanies you from the development of your product to delivery.

We offer you the following services

Product Safety:

  • Product and equipment safety tests according to harmonized standards such as IEC EN 61010-x as the basis of the conformity assessment procedure – for comprehensive product evaluation, we offer tests for electrical and mechanical product safety, thus indicating that your products meet the latest safety requirements
  • Test programs for measuring, control, and laboratory equipment for special applications (IEC 60601-2-xx)
  • Testing and certification according to the IECEE CB procedure
  • Consideration of national deviations from the international IEC standard version
  • US-NRTL certification according to ANSI/AAMI ES61010-1 and CAN/CSA-C22.2 No. 61010-1
  • Tests and design analyses through the course of product development
  • Gap analysis program for new versions of the IEC 61010 series of standards
  • Training and webinars on the current content of standards – further information
  • Individual product safety workshops

Electromagnetic compatibility (EMC):

  • Both in Europe and in many other international markets, compliance with EMC requirements according to IEC 61326-1 or the relevant particular requirements according to IEC 61326-2-x is required for classic electrical measuring, control, and laboratory equipment. For the testing of these EMC requirements, we are at your disposal with our expert test engineers and excellent equipment
  • Furthermore, in addition to IEC 61326-1, additional requirements with regard to immunity to interference according to IEC 61326-3-1 must be complied with if electrical measuring, control, regulation, and laboratory equipment is intended for safety-related functions (functional safety)
  • Testing of the specific requirements for medical in vitro diagnostic devices (IVD) according to IEC 61326-2-6
  • EMC testing and certification according to the IECEE CB procedure
  • Testing of USA EMC and radio requirements according to Part 15 and Part 18 of the Federal Communications Commission (FCC) for your Suppliers Declaration of Conformity (SDoC) or Certification
  • Evaluation of "combined equipment," i.e. devices and systems that use radio technologies to send or receive data, for which the following standards apply: ETSI EG 203 367 with EN 301 489-x and, for instance, EN 300 220 or EN 300 328
  • Training and webinars on the current content of standards – further information
  • Individual EMC workshops

Our EMC laboratory has several absorber halls with measuring distances of 3 m and 10 m for radiated emissions and immunity testing, as well as shielded measuring rooms and other measuring stations for conducted EMC tests. Of course, we have connections for cooling water, compressed air, exhaust gas extraction, and special pipes, and also large test samples with up to 55 to/m2 and 125A per phase can be tested.

Other SGS Group services:

  • Environmental simulation testing for mechanical, climatic, and corrosive influences such as IP protection class tests, leak tests, transport tests, qualification of connectors and connection technologies – further information
  • Chemical product testing for undesirable and prohibited substances, as well as testing according to the RoHS Directive (this requires that only electrical and electronic equipment whose homogeneous materials do not exceed the limit values of heavy metals such as cadmium, lead, mercury, chromium VI, and some brominated flame retardants may be placed on the market)

An excerpt of our test spectrum can be found here.

 

Contact

Armin Hudetz
t: +49 89 78 74 75-133
f: +49 89 12 50 40 64-133
E-Mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

Customer Service Team
t: +49 89 78 74 75-222
f: +49 89 12 50 40 64-100
E-Mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

 

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