We look forward to hearing from you!

All information except your name and email address is optional.

The more details you give us, the faster and more effectively we can address your requirements.

Your medical device

Chemical Characterization / Analytics

Biocompatibility

Microbiology

Electrical Safety Rehabilitation

Medical Care and Physical Therapy

Functional Safety

Electromagnetic Compatibility (EMC)

MRI Safety & MRI Compatibility

Radio Equipment – Testing and Global Market Access

Battery Testing for Medical Products

Cyber Security & Software

Certification and Global Market Access for Active Medical Devices

Environmental & Packaging Testing

Other

Chemical Characterization / Analytics

Toxicological Risk Assessment (ISO 10993-17)

GCMS (ISO 10993-18)

GCMS-HS (ISO 10993-18)

LCMS (ISO 10993-18)

ICP-OES / ICP-MS (ISO 10993-18)

EO (ISO 10993-18)

Biocompatibility

Biological Evaluation Plan (ISO 10993-1)

Irritation (ISO 10993-10)

Implantation (ISO 10993-6)

Cytotoxicity (ISO 10993-5)

Sensitisation (ISO 10993-10)

Acute, subacute, subchronic and / or chronic systemic toxicity (ISO 10993-11)

Pyrogen test (ISO 10993-11)

Genotoxicity test (e.g. AMES) (ISO 10993-3)

Hemocompatibility (ISO 10993-4)

Microbiology

Bioburden validation & determination (ISO 11737-1)

Bacterial Endotoxin (LAL) validation & determination (USP)

Sterility validation (growth promotion test) & determination (ISO 11737-2)

Manual & automated reprocessing (ISO 17664)

Electrical Safety

IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

IEC 60601-1-xx: Medical electrical equipment – Part 1-xx: General requirements for basic safety and essential performance – Collateral standards

IEC 60601-2-yy and IEC / ISO 80601-2-yy: Medical electrical equipment – Part 2-yy: Particular requirements for basic safety and essential performance

IEC 61010-1 Electrical equipment for measurement / control and laboratory use – Part 1: General Requirements

IEC 61010-2-yy: Safety requirements for electrical equipment for measurement / control and laboratory use – particular requirements for basic safety and essential performance

ANSI / AAMI ES 60601-1:2005 / (R)2012 (USA)

CAN / CSA C22.2 NO. 60601-1:14 (Canada)

JIS T0601-1:2012 (IEC 60601-1:2005) (Japan)

KS C IEC 60601-1:2011 (Korea)

Rehabilitation, Medical Care and Physical Therapy

Testing of manual wheelchairs (EN 12183; ISO 7176-ff)

Testing of electrical wheelchairs and scooters (EN 12184; ISO 7176-ff)

Testing of medical electrical beds (IEC 60601-2-52; IEC 60601-1; EN 50637)

Testing of patient hoists (EN ISO 10535)

Testing of technical aids (EN 12182)

Testing of assistive products for personal hygiene (ISO 17966)

Testing of walking aids / rollators (DIN EN 1985; DIN EN ISO 11199)

Testing of OR tables and benches for treatment (IEC 60601-2-46; IEC 60601-1)

Testing of rehabilitation robots (IEC 60601-1; IEC 80601-2-78)

Testing of Active-Passive-Trainer (IEC 60601-1)

Testing of medical training equipment for physical therapy (IEC 60601-1; EN ISO 20957-ff; EN 957-ff)

Testing of hearing aids (IEC 60601-1; IEC 60601-2-66)

Functional Safety

IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance – Subclause 4.3 and Subclause 4.7: Essential Performance under Single Fault Condition

IEC 60601-2-yy and IEC / ISO 80601-2-yy: Medical electrical equipment – Part 2-yy: Particular requirements for basic safety and essential performance – e.g. Subclause 201.4.3; 201.4.7; 201.12: Essential Performance; Single Fault Condition

Interpretation Sheet ISH: IEC 60601-1 / AMD1 / ISH1 ED3

Electromagnetic Compatibility (EMC)

IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances - Requirements and tests

IEC 60601-2-x: Medical electrical equipment – Part 2-x: Particular requirements for the basic safety and essential performance

IEC TR 60601-4-2: Medical electrical equipment – Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems

IEC 61326-1: Electrical equipment for measurement. control and laboratory use

Additional EMC testing following the RED directive may be required: ETSI EN 301 489-1; -3; -17

MRI Safety & MRI Compatibility

Measurement of magnetically induced displacement force in the static magnetic field (ASTM F2052)

Measurement of magnetically induced torque in the static magnetic field (ASTM F2213)

Measurement of radio frequency induced heating on the device (ASTM F2182)

Evaluation of image artefacts with artefacts surface measurement (ASTM F2119)

Device marking (ASTM F2503)

Radio Equipment – Testing and Global Market Access

ETSI EN 300 328 Serie / ETSI EN 301 893 Serie

ETSI EN 300 220 Serie / ETSI EN 300 330 Serie

ETSI EN 301 839 Serie / ETSI EN 303 203 Serie

ANSI C63.10 Serie / FCC Part 15 B / FCC Part 15 C

RSS-Gen / RSS-210 / RSS-247

Japan ARIB Standards / MIC Ordiances

Modular Transmitter Integration Testing according to RED / FCC / RSS Requirements

FDA Wireless Co-Existence Standard IEEE ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence

Wireless Global Market Access für 180 Länder

Battery Testing for Medical Products

IEC 62133-1 Safety requirements for portable sealed secondary cells and for batteries made from them. for use in portable applications – Part 1: Nickel systems

IEC 62133-2 Safety requirements for portable sealed secondary cells and for batteries made from them. for use in portable applications – Part 2: Lithium systems

CB certification according to IEC 62133-1 or IEC 62133-2

UN 38.3 Transportation testing for lithium batteries. safety of lithium ion or lithium metal batteries during shipping

Cyber Security & Software

IEC 62443: Industrial communication networks - Network and system security

IEC 62304: Medical device software - Software life cycle processes

Certification and Global Market Access for Active Medical Devices

IECEE CB certification (IEC 60601-1 series)

NRTL certification under OSHA (US) und SCC (CAN) accreditation

INMETRO – certification for Brazil

Environmental & Packaging Testing

Real-time aging

Transport simulation (e.g. ISTA 2A; ISTA 2B; ISTA 3A; ISTA 3B)

Packaging testing (ISO 11607)

ASTM series

IEC 60529: Degrees of protection provided by enclosures (IP Code)

IEC 60068

IEC 60721: Classification of environmental conditions

Your medical device

Please describe your medical device (including its intended purpose)

Please tick your phase of product development:

Planning

Development

Verification & Validation

Design Transfer

Marketing approval

Production

Other

Please complete the required field.

Scheduled start of tests

Please complete the required field.

Preferred date for completion of tests

Supporting documentation (e.g. pictures of the product, data sheet, operating / instruction manual or installation instructions, product specifications, type plate, pictures, technical drawing, relevant certificates).

Filenames

Drag files here or click to upload.

Maximum data volume of all uploads: 34 MB
Allowed formats: jpg, tif, png, gif, doc, docx, xls, xlsx, ppt, pptx, pdf, zip

Your personal data

Title

Academic title

First name

Last name

Email address

Telephone/Mobile

Your address

Company name

Street

House number

Postal code

Location

Country

Yes, I would like to receive marketing information from TÜV SÜD Product Service GmbH and TÜV SÜD's legal entities relating to their products and services.

I may withdraw my consent at any time with future effect. For further details, we refer to our Privacy Notice.

The fields marked with * are mandatory.