Medical devices
Safety & Preclinical testing
Verification of medical devices safety is mandatory for all manufacturers. We provide safety tests according to IEC/EN 60601 and IEC/EN 61010 standards series, biocompatibility tests according to ISO 10993 standards series and usability testing and evaluation according to IEC/EN 62366-1 to verify the basic safety and the essential performance of active medical devices.
Biocompatibility testing:
|
Standard, legislation, guidance |
Description |
| ISO 10993-3 | Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| ISO 10993-4 | Selection of tests for interactions with blood |
| ISO 10993-5 | Tests for in vitro cytotoxicity |
| ISO 10993-6 | Tests for local effects after implantation |
| ISO 10993-7 | Ethylene oxide sterilization residuals |
| ISO 10993-9 | Framework for identification and quantification of potential degradation products |
| ISO 10993-10 | Tests for irritation and skin sensitization |
| ISO 10993-11 | Tests for systemic toxicity |
| ISO 10993-13 | Identification and quantification of degradation products from polymeric medical devices |
| ISO 10993-14 | Identification and quantification of degradation products from ceramics |
| ISO 10993-15 | Identification and quantification of degradation products from metals and alloys |
| ISO 10993-16 | Toxicokinetic study design for degradation products and leachables |
| ISO 10993-17 | Establishment of allowable limits for leachable substances |
| ISO 10993-18 | Chemical characterization of materials |
| ISO 11737-1 | Determination of bioburden |
| ISO 11737-2 | Tests of sterility |
| Ph. Eur. | Bacterial endotoxin test |
Safety testing:
|
Standard, legislation, guidance |
Description |
|
EN 60601-1 (IEC 60601-1) |
Medical electrical equipment |
|
EN 60601-1-6 (IEC 60601-1-6) |
Medical electrical equipment – Usability |
|
EN 60601-1-8 (IEC 6060-1-8) |
Alarm systems in medical electrical equipment and medical electrical systems |
|
EN 60601-2-10 (IEC 60601-2-10) |
Nerve and muscle stimulators |
|
EN 60601-2-25 (IEC 60601-2-25) |
Electrocardiographs |
|
EN 60601-2-26 (IEC 60601-2-26) |
Electroencephalographs |
|
EN 60601-2-27 (IEC 60601-2-27) |
Electrocardiographic monitoring equipment |
|
EN 60601-2-47 (IEC 60601-2-47) |
Ambulatory electrocardiographic systems |
|
EN 60601-2-4 (IEC 60601-2-4) |
Cardiac defibrillators |
|
EN 80601-2-30 (IEC 80601-2-30) |
Automatic cycling non- invasive blood pressure monitoring equipment |
|
EN 61010-1 (IEC 61010-1) |
Electrical equipment for measurement, control, and laboratory use |
|
EN 61010-2-101 (IEC 61010-2-101) |
Particular requirements for in vitro diagnostic (IVD) medical equipment |
Usability testing:
|
Standard, legislation, guidance |
Description |
| EN 62366-1 | Formative evaluation (expert review, standard review) |
| EN 62336-1 | Summative evaluation (Usability test)Cybersecurity testing |
Cybersecurity testing:
|
Standard, legislation, guidance |
Description |
| ISO 80001-5-1 | Threat modelling |
| ISO 80001-5-1 | Secure requirements testing |
| ISO 80001-5-1 | Threat mitigation testing |
| ISO 80001-5-1 | Vulnerability testing |
|
ISO/IEC 18045 ISO/IEC 15408-1, -2, -3 |
Common Criteria testing |
RoHS testing:
|
Standard, legislation, guidance |
Description |
| RoHS Annex II | Determination of the concentration of hazardous substances |
Product equipment testing:
|
Standard, legislation, guidance |
Description |
| (MD, LVD, EMC, ATEX) | CE conformity testing: • documentation evaluation • visual inspection • functional examination • instrumental measurements (on-site or laboratory) |
| (relevant occupational safety and health regulations) | Safety tests: • preliminary • periodic • extraordinary |
| MD, EN ISO 14159 | Hygienic inspection of production equipment |
| (specified standards or other specifications) | Other conformity tests, acceptance checks: • according to standards • according to customer or other specifications • according to a customized system of criteria |