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


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


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)


EN 60601-2-26

(IEC 60601-2-26)


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


EN 62366-1 Formative evaluation (expert review, standard review)
EN 62336-1 Summative evaluation (Usability test)Cybersecurity testing


Cybersecurity testing:

Standard, legislation, guidance


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


RoHS Annex II Determination of the concentration of hazardous substances


Product equipment testing:

Standard, legislation, guidance


(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