Product safety: Electrical, mechanical, radiation, usability, software


The IEC 60601-1 standard is essential for manufacturers or repair shops of electrically operated medical devices.
The standard covers an essential part of compliance with the EU MDR and FDA requirements.

The training starts with a part that is not safety standard specific but describes the standardization organizations, international and regional (EU, USA, Canada),
how the standards are created and how they are implemented in the regulations.

Labquality provides IEC 60601-1 standard training, during which you will learn about the basic safety and essential performance of the standard, its content and requirements.
Although the training mainly covers medical devices, training also briefly addresses IVD device safety standard 61010-1.

About the IEC 60601-1 Standard

IEC 60601-1 is the basic safety standard for medical electrical devices and systems. It is a risk-based standard.

By meeting the requirements of IEC 60601-1, a medical device meets the requirements for Basic Safety. This means that when the device is operating in normal condition
or has a single fault condition, there are no hazards that would cause unacceptable risk to the patient or user.

By meeting the requirements of the standard, a medical device also meets the requirements for Essential Performance.
This refers to the performance of a clinical function other than basic safety, where loss or degradation beyond the specific limits cause an unacceptable risk.

The IEC 60601-1 standard includes 420 pages and covers, e.g.:

– Testing the equipment
– Classification of the equipment (IEC 60601-1 classification)
– Identification, marking and documents
– Electrical safety
– Usability
– Radiation
– Software and systems
– Construction of the equipment
– Electromagnetic compatibility

The standard is a harmonized standard to the Medical Device Directive. It will be harmonized to the Medical Device Regulation ETA in 2024 as EN 60601-1

The standard includes references to particular and collateral standards.

 


 

SPRING 2022
Time:
30.3. and 1.4. at 9.00-12.00 (EET)

Paikka: Online
Hinta: 790€ + VAT 24%

AUTUMN 2022
Time:
16.11. and 17.11. at 9.00-12.00 (EET)

Paikka: Online
Hinta: 790€ + VAT 24%

Target audience:
Designers of medical electrical equipment (electronics / mechanics / radiation / usability / software), persons responsible for requirements, persons responsible for device risk management, persons responsible for the quality system.

After the training:

  • You will understand the content of the standard and how to use it.
  • You will be able to combine the standard with other device-specific standards.
  • You will recognise the risks that the standard requires you to consider.
  • You will know how the standard requirements will soon change.

Trainer:


Jouni:
”I’m an experienced specialist in approvals and registrations of medical devices (MD) and quality systems. I have over 10 years in MD product development and over 10 years in quality and regulatory affairs. I have strong knowledge of safety standards for medical devices. I’m also an experienced auditor and can audit according to ISO 13485 standard. Due to my working experience with electrical devices, I have a strong background on Electromagnetic compatibility issues.”

 

CONTENT:

  • Why standard?
  • Standardization organizations
  • Regulatory requirements and standards
  • Main standards
  • Relationships with IEC standards
  • Introduction to IEC 60601-1
  • The future of IEC 60601-1 in brief
  • How do I read a standard
  • IEC 60601-1 requirements and tests
    • Usability
    • Software
    • Mechanics
    • EMC
    • Future

BILLING AND CANCELLATION POLICY 
Participation in the training can be cancelled two weeks (14 days) before the event free of charge. For cancellations made after this, we will charge 50% of the participation fee, except for cancellations made one week before the event, we will charge a 100% participation fee.

Cancellations are always made in writing to: koulutus@labquality.fi.  
The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to: koulutus@labquality.fi. The participation fee will be invoiced immediately after the event. The training session will be confirmed to the participant by e-mail about a week before the event.  Labquality reserves the right to cancel the training session due to a small number of participants.

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