IEC 60601 -standard
IEC 60601 on sarja teknisiä standardeja lääkinnällisten sähkölaitteiden turvallisuudelle ja olennaiselle suorituskyvylle.
IEC 60601 is a series of technical standards that describes the requirements for the safety and essential performance of medical electrical equipment. The series consists of a one general standard and about 10 collateral standards that supplement the general standard for all electrical medical equipment. In addition, the series includes 80 particular standards for specific requirements of particular medical electrical devices.
With Kasve’s support you can identify the applicable standards that concern your medical electrical equipment and get tools to effectively implement the standards requirements.
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IEC 60601 -standard
IEC 60601 is a series of technical standards that describes the requirements for the safety and essential performance of medical electrical equipment.
IEC 62304 -standard
IEC 62304 defines the set of processes for life-cycle management of medical device software.
ISO 13485 -standard
The ISO 13485 standard sets a frame for quality management systems for both medical device manufacturers and other organisations in the chain.