| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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066
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Date of Entry 05/25/2026
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FR Recognition Number
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6-521
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| Standard | (Included in ASCA) |
IEC 60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories [Including: Amendment 1 (2023), Interpretation Sheet 1 (2025)] |
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Scope/AbstractThis part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES as defined in 201.3.224 and 201.3.223.
HF SURGICAL EQUIPMENT having a RATED OUTPUT POWER not exceeding 50 W (for example for micro-COAGULATION, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this particular standard. These exemptions are indicated in the relevant requirements.
The consolidated version includes Amendment 1 and Interpretation Sheet 1.
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| Extent of Recognition
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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. |
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Transition Period
| FDA recognition of IEC 60601-2-2 Edition 6.0 2017-03 [Rec# 6-389] will be superseded by recognition of IEC 60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION [Rec# 6-521]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-389] until July 1, 2029. After this transition period, declarations of conformity to [Rec# 6-389] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §876.1500 |
Cystoscope And Accessories, Flexible/Rigid
|
Class 2
|
FAJ
|
| §876.1500 |
Sigmoidoscope And Accessories, Flexible/Rigid
|
Class 2
|
FAM
|
| §876.1500 |
Choledochoscope And Accessories, Flexible/Rigid
|
Class 2
|
FBN
|
| §876.1500 |
Cystourethroscope
|
Class 2
|
FBO
|
| §876.1500 |
Enteroscope And Accessories
|
Class 2
|
FDA
|
| §876.1500 |
Colonoscope And Accessories, Flexible/Rigid
|
Class 2
|
FDF
|
| §876.1500 |
Gastroscope And Accessories, Flexible/Rigid
|
Class 2
|
FDS
|
| §876.1500 |
Duodenoscope And Accessories, Flexible/Rigid
|
Class 2
|
FDT
|
| §876.1500 |
Anoscope And Accessories
|
Class 2
|
FER
|
| §876.1500 |
Ureteroscope And Accessories, Flexible/Rigid
|
Class 2
|
FGB
|
| §876.1500 |
Urethroscope
|
Class 2
|
FGC
|
| §876.1500 |
Resectoscope
|
Class 2
|
FJL
|
| §876.1500 |
Endoscope, Rigid
|
Class 2
|
GCM
|
| §876.1500 |
Endoscope, Flexible
|
Class 2
|
GCQ
|
| §876.1500 |
Mini Endoscope, Gastroenterology-Urology
|
Class 2
|
ODF
|
| §876.4300 |
Unit, Electrosurgical
|
Class 2
|
FAR
|
| §876.4300 |
Electrode, Electrosurgical, Active, Urological
|
Class 2
|
FAS
|
| §876.4300 |
Snare, Flexible
|
Class 2
|
FDI
|
| §876.4300 |
Electrode, Flexible Suction Coagulator
|
Class 2
|
FEH
|
| §876.4300 |
Forceps, Biopsy, Electric
|
Class 2
|
KGE
|
| §876.4480 |
Lithotriptor, Electro-Hydraulic
|
Class 2
|
FFK
|
| §878.4400 |
Electrosurgical, Cutting & Coagulation & Accessories
|
Class 2
|
GEI
|
| §878.4400 |
Electrode, Electrosurgical
|
Class 2
|
JOS
|
| §878.4400 |
System, Ablation, Microwave And Accessories
|
Class 2
|
NEY
|
| §878.4400 |
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
|
Class 2
|
NUJ
|
| §878.4400 |
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
|
Class 2
|
OCL
|
| §878.4400 |
Electrosurgical Patient Return Electrode
|
Class 2
|
ODR
|
| §884.4120 |
Electrocautery, Gynecologic (And Accessories)
|
Class 2
|
HGI
|
| §884.4150 |
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
|
Class 2
|
HIN
|
| §884.4160 |
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
|
Class 2
|
KNF
|
|
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
2. Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery, issued August 2016.
3. Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, issued March 2020.
4. Guidance for Industry: Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters, issued November 1998.
5. Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology, issued February 1993.
6. IEC 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
|
| Standards Development Organization
|
FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
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| *These are provided as examples and others may be applicable. |
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