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:

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:

EN 62366-1

Formative evaluation (expert review, standard review)

EN 62336-1

Summative evaluation (Usability test)

 

 

Cybersecurity testing:

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:

RoHS Annex II

Determination of the concentration of hazardous substances

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