Services for Medical Devices

September 2020Project Management

www.ctcadvanced.com | mail@ctcadvanced.com

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CTC advanced GmbHMedical Device - Definition

ACCORDING TO REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT

„Medical device“ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination,

for human beings for one or more of the following specific medical purposes: ○ ○ ○• Diagnosis, prevention, monitoring, prediction, prognosis,

treatment or alleviation of disease

• Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability

• Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state

• Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

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CTC advanced GmbHOur Core Competences

• Electrical Safety & EMC for Medical Devices

• RED - Radio Equipment Directive (2014/53/EU)

• Electroacoustic Hearing Aid Measurements

• Hearing Aid Compatibility (HAC) - Mobile Phones & Telecom equipment

• Coexistence tests for wireless medical devices • Environmental Testing - Shock, Vibration, Climatic, IP... • Transportation Tests

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CTC advanced GmbHOur Accreditations - Electrical Safety Medical Devices

DAkkS / ISO 17025 CB-Scheme Title

DIN EN / IEC 60601-1 IEC 60601-1 General requirements

- IEC 60601-1-6 Usability

DIN EN / IEC 60601-1-8 - Alarm Systems

DIN EN / IEC 60601-1-11 IEC 60601-1-11 ME used in the home health-care environment

DIN EN / IEC 60601-2-66 IEC 60601-2-66 Hearing Instruments and Hearing Instrument Systems

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CTC advanced GmbHOur Accreditations - Electrical Measurement, Control,

Regulation and Laboratory Equipment

DAkkS / ISO 17025 CB-Scheme Title

-IEC 61010-1 General requirements

- IEC 61010-2-010 Laboratory equipment for the heating of materials

- IEC 61010-2-030 Testing and measuring circuits

- IEC 61010-2-032 Hand-held and hand-manipulated current sensors for electrical test and measurement

DIN EN / IEC 61010-2-040 - Sterilizers and washer-disinfectors used to treat medical materials

- IEC 61010-2-081 Automatic and semi-automatic laboratory equipment for analysis and other purposes

DIN EN / IEC 61010-2-101 IEC 61010-2-101 In vitro diagnostic (IVD) medical equipment

- IEC 61010-031 Hand-held probe assemblies for electrical measurement and test

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DAkkS / ISO 17025 CB-Scheme Title

DIN EN / IEC 60601-1-2 IEC 60601-1-2 Electromagnetic disturbances - Requirements and tests

DIN EN / IEC 60118-13 - Electroacoustics - Hearing aids - Part 13: EMC, Immunity to digital wireless devices

DIN EN / IEC 61326-2-6 IEC 61326-2-6Electrical equipment for measurement, control

and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD)

medical equipment

CTC advanced GmbHOur Accreditations - EMC Medical Devices

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CTC advanced GmbHOur Accreditations Hearing Aid Compatibility

Hearing Aid Compatibility (HAC)

• ANSI C63.19 (required by FCC for US market)

• M-Rating and T-Rating (to assist hearing aid users in finding wireless devices which are compatible with their hearing aids)

• DASY5 test system - RF interference measurements according to ANSI C63.19, E-field emission

and H-field emission - Audio frequency measurements according to ANSI C63.19, T-Coil signal amplitude,

T-Coil frequency response and T-Coil signal to noise measurement

• Scope of HAC tests- FCC: CFR 47 FCC Part 68 (USA) - ISED: IC CS-03 Part V (Canada)

- AS/ACIF S040 (Australia) - ETS 300 381 (Europe) - ETSI ES 200 381-2

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CTC advanced GmbHProcedure of Medical Device Testing

CTC advanced

GmbH

Request Customer to

Sales

KICK-OFF MEETING / TELCO

PRESENTATIONTEST SPECIMEN

CREATION OFFINAL OFFEREXAMINATIONS

CREATION OFPRELIMINARY

OFFER

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Company Management | www.ctcadvanced.com | mail@ctcadvanced.com

Market-Launch

Certification

TypeApproval

Test

Pre- Test

Test-Definition

„GET READY TO LAUNCH“