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сертификаты

Качество и безопасность являются ключевыми для LINAK. Производители должны знать требования к тестированию и сертификации медицинского оборудования. LINAK поставляет сертификаты для продуктов и систем нашим клиентам, чтобы облегчить процесс сертификации оборудования

На этапе разработки стандарты, приведенные ниже, были учтены LINAK, чтобы соответствовать требованиям, предъявляемым к сертификации разработок клиентов. В общем, линейка продуктов LINAK соответствует следующим правилам:

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 – Part 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 – Part 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 relate to product misuse or situations that can cause risks when the product is in use and we make 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. 

Использование MEDLINE & CARELINE
Посмотрите примеры использования продукции MEDLINE & CARELINE.
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