Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

064

Date of Entry 05/26/2025

FR Recognition Number

6-510

Standard

(Included in ASCA)

IEC 80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION
Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT

Scope/Abstract

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. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

If RASE or RASS, or its ACCESSORIES fall within scope of another particular standard, then the particular standard applies in addition to this standard.

Extent of Recognition

Complete standard

Rationale for Recognition

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Transition Period

FDA recognition of IEC 80601-2-77 Edition 1.0 2019-07 [Rec# 6-438] will be superseded by recognition of IEC 80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION [Rec# 6-510]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-438] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 6-438] will not be accepted.

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§876.1500	System, Surgical, Computer Controlled Instrument	Class 2	NAY
§878.4961	Mountable Electromechanical Surgical System For Transluminal Approaches	Class 2	QNM
878.4962	Table Mounted Miniaturized Electromechanical Surgical System	Class 2	SAB
878.4963	Electromechanical System For Open Microsurgery	Class 2	SAQ
878.4964	Modular Electromechanical Surgical System	Class 2	SCV
878.4965	Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field	Class 2	SDD

Relevant FDA Guidance and/or Supportive Publications*

AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

IEC TR 60601-4-1:2017 Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contacts

Sheldon Davis

FDA/OC/CDRH/OPEQ/OHTVI/DHTVIC/

301-796-4034

Sheldon.Davis@fda.hhs.gov

Mark Trumbore

FDA/CDRH/OPEQ/OHTIV/DHTIVA

301-796-5436

Mark.trumbore@fda.hhs.gov

Gabrielle Clark-Patterson

FDA/CDRH/OPEQ/OHTIV/DHTIVA

240-402-2817