SGS Germany GmbH

SGS is the world's leading company in the fields of testing, inspection and certification.

At our competence center in Puchheim near Munich, we have state-of-the-art testing and simulation facilities at your disposal.

With our many years of experience and a broad international network of testing laboratories and certification bodies, we test and certify your products in accordance with national and international standards and regulations, such as Medical Device Regulation 2017/745 (MDR), 2017/746 In-vitro diagnostics (IVDR), IEC/EN 60601-x (e.g. EMC, product safety).

NOTED OFFICE

EU conformity assessment (certification / "CE marking") according to European Medical Device Regulation 2017/745 (MDR), including ISO 13485  

TESTING LABORATORY PRODUCT SAFETY 

As part of our accreditations according to DIN EN ISO/IEC 17025:2018 and recognition as a CB test laboratory within the IECEE CB scheme, we offer the following services:

• Safety testing in accordance with the DIN EN IEC 60601/80601 series of standards for active medical devices and systems with verification of national deviations and special features (e.g. USA: ANSI AAMM).e.g. USA: ANSI AAMI, Canada: CAN CSA, Japan: JIS T or Korea: KS C) for global recognition. 
• Diagnostic X-ray equipment (IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54)
• Devices for patient monitoring and diagnosis of vital parameters (IEC 60601-2-25, IEC 60601-2-27, IEC 80601-2-30, IEC 60601-2-34, IEC 80601-2-49, ISO 80601-2-55, ISO 80601-2-56, ISO 80601-2-61)
• Emergency and intensive care devices (IEC 60601-2-4, ISO 80601-2-12, ISO 80601-2-84)
• Assistant robots (IEC 80601-2-77, IEC 80601-2-78)
• Medical devices for domestic use (IEC 60601-1-11).
• devices in emergency use, e.g. in ambulances, helicopters or use in aircraft (IEC 60601-1-12, EN 1789, EN 13718, RTCA DO-160G).
• Medical device software according to IEC 62304
• Active implantable medical devices according to ISO 14708-1, ISO 14708-2, ISO 14708-3 and ISO 14708-7
• Laboratory and measurement technology products and in-vitro diagnostics (IVD) according to IEC 61010-x
• Lithium batteries according to IEC 62133-2
• Testing and certification according to IECEE CB procedure
• US-NRTL certification according to ANSI/AAMI ES60601-1 and CAN/CSA-C22.2 No. 60601-1
• INMETRO certification for access to the Brazilian market
• In-process testing and design analysis
• Gap analysis program for IEC 60601-1:2020 Amendment 2
• Individual product safety workshops
• Trainings and webinars on the current standard content

TESTING LABORATORY ELECTROMAGNETIC COMPLIANCE (EMC)

In the internationally accredited EMC laboratory of SGS Munich, with several shielding cabins and absorber halls (3 m and 10 m), competent test engineers and high-quality test equipment are at your disposal. We test electrical and electronic devices and systems for medical technology such as diagnostic X-ray equipment, devices for emergency and intensive care medicine, patient monitoring, assistance robots, operating theater technology and lighting.

Our portfolio includes:

• EMC testing in accordance with DIN EN IEC 60601-1-2, taking into account applicable particulate standards (IEC/ISO 60601-2-xx, 80601-2-xx), including review and verification of test plans, risk analysis and instructions for use. Our immunity tests include the verification of basic safety and essential performance, in which we follow the instructions from IEC TR 60601-4-2. We can provide simulators and measuring devices for monitoring a wide range of device types.
• Seminars on the content, interpretation and targeted application of IEC 60601-1-2:2014 (+AMD1:2020), including information on creating test plans, EMC risk management considerations and taking national country deviations into account.
• Testing for potential interference from RFID/EAS systems according to currently recognized test methods "proximity to magnetic fields" (30 kHz, 134.2 kHz, 13.56 MHz) in accordance with IEC 60601-1-2:2014 + AMD1:2020 and AIM 7351731
• "out of hospital" test program for devices and systems that are also used outside the professional clinical environment, e.g. in the home environment and in emergencies (CISPR 25, ISO 7637-2, RTCA DO-160G)
• "combined equipment" tests - medical devices and systems that integrate radio technologies (ETSI EG 203 367 with EN 301 489-x and e.g. EN 300 220 or EN 300 489-x).e.g. EN 300 220 or EN 300 328)
• Testing of in-vitro diagnostics (IVD) and laboratory equipment, e.g. in accordance with IEC EN 61326

Testing service: SGS tests product quality against any health standards, safety requirements or regulations. SGS has state of the art accredited laboratories and facilities and always acts in cooperation with the client.

Inspection service: SGS inspects and checks the quality and quantity of commercial goods. These inspections can be carried out during and/or directly after production as well as during loading or reloading.

Certification service: SGS certifies according to legal requirements, certification standards such as ISO 9000, ISO 13485 or according to the customer's wishes. In addition, SGS develops and certifies its own standards.