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I.S. EN IEC 80601-2-77:2021

Current
Current

The latest, up-to-date edition.

Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

18-10-2021

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation HAZARDS
201.11 Protection against excessive temperatures and other HAZARDS
201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 * ME SYSTEMS
201.17 * ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS
202 ELECTROMAGNETIC DISTURBANCES – Requirements and tests
206 * USABILITY
Annexes
Annex D (informative) Symbols on marking
Annex AA (informative) Particular guidance and rationale
Annex BB (informative) Equations for the calculation of the overall system stopping performance and minimum distances
Annex CC (informative) Stopping functions of the RASE
Annex DD (informative) Alternative method to demonstrate structural integrity throughout the EXPECTED SERVICE LIFE of the RASE
Annex EE (informative) Example of a testing method of the IMMUNITY test for HF SURGICAL EQUIPMENT emissions
Bibliography

This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), hereafter referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS.

Committee
SC 62D
DocumentType
Standard
ISBN
978-2-8322-6999-2
Pages
126
ProductNote
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
EN IEC 80601-2-77:2021 Identical
IEC 80601-2-77:2019 Identical

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