EVS-EN IEC 80601-2-77:2021
Medical Electrical Equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
1Key Takeaways
IEC 80601-2-77:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS.
2Scope / Description
IEC 80601-2-77:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS.
3Version History
5Citation Network
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6Frequently Asked Questions
What is EVS-EN IEC 80601-2-77:2021?
EVS-EN IEC 80601-2-77:2021 — Medical Electrical Equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment is an international standard developed by Estonian Centre for Standardisation. IEC 80601-2-77:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION...
What does EVS-EN IEC 80601-2-77:2021 cover?
This standard covers: IEC 80601-2-77:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS.
Who should use this standard?
This standard is intended for organizations, professionals, and stakeholders involved in the medical device and healthcare industry. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.
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