Approvals

Approvals

 
 

Quality and Safety are key issues for LINAK. Application manufacturers have to be aware of the requirements for testing and certification of the final medical equipment. LINAK delivers certificates for products and systems to our customers to ease the application certification process.

In the development phase, the standards below have been taken into consideration by LINAK in order to comply with the regulations required for a customer application certification. In general, the LINAK product line complies with the following regulations for product approvals:

EN IEC 60601-1
This standard describes the general requirements for medical electrical equipment – Part 1 for basic safety and essential performance

ANSI/AAMI ES60601-1
This standard describes the general requirements for medical electrical equipment – Part 1 for basic safety and essential performance

CSA CAN/CSA-C22.2 NO. 60601-1
This standard describes the general requirements for medical electrical equipment - Part 1 for basic safety and essential performance

AS/NZS 60601.1
This standard describes the general requirements for medical electrical equipment – Part 1 for basic safety and essential performance

AS/NZS 60601.1.2
This standard describes the general requirements for medical electrical equipment – Parts 1-2 for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests

EN IEC 60601-1-2
This standard describes the general requirements for medical electrical equipment – Parts 1-2 for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests. The ESD tests are required to live up to this EMC standard and testing at 8 kV is required. However, to ensure high safety and reliable products at all times LINAK tests up to 25 kV.


LINAK also complies with relevant parts of the following standards required for customer application certification:

EN IEC 60601-2-52
This standard describes the particular requirements within medical electrical equipment for basic safety and essential performance of medical beds.

EN 50637
This standard describes the particular requirements within medical electrical equipment for the basic safety and essential performance of medical beds for children. 

EN ISO 10535
This standard describes the requirements and test methods within hoists for the transfer of persons with a disability. 

EN IEC 12182
This standard describes the general requirements and test methods within assistive products for persons with a disability.

ISO 17966
This standard describes the requirements and test methods within assistive products for personal hygiene that support users.

Focus on Risk Management and Usability
To be aligned with the requirements in IEC 62366, LINAK has a well-defined Risk Management process including usability engineering processes. We address product misuse or situations that can cause risks when the product is in use, and we provide recommendations and warnings to reduce the risk.

LINAK is certified in accordance with the ISO14971 Risk Management standard. We provide residual risk documentation for all our components to help the application manufacturer in the risk analysis process. 

Files

Safety folder

Different applications need different safety features. Regardless of what healthcare application you are designing, LINAK offers a wide variety of standard and optional safety features.

MEDLINE & CARELINE product overview

Dive into the wide variety of innovative MEDLINE & CARELINE products that can help you improve your hospital and healthcare equipment.

Have a question about electric actuator technology?

- We are not psychics. But, we are experts in actuator technology. So do not hesitate to ask us anything about that.