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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 042 Date of Entry 06/15/2016 
FR Recognition Number 3-132
ISO  27185 First edition 2012-02-15
Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels, and Information to be Supplied - General Requirements
Identical Adoption
ANSI AAMI ISO 27185:2012
Cardiac Rhythm Management Devices -- Symbols to be Used With Cardiac Rhythm Managment Device Labels, and Information to be Supplied -- General Requirements
ISO 27185:2011 specifies requirements for the use of symbols conveying information on the safe and effective use of cardiac rhythm management medical devices. A listing is given of existing symbols that comply with the requirements of ISO 27185:2011.

ISO 27185:2011 is applicable to, and limited to, symbols for cardiac rhythm management medical devices that can be marketed globally. These symbols can be used on the devices themselves or their labelling.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.1750 Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) Class 2 JOQ
§870.3600 Pulse-Generator, Pacemaker, External Class 2 DTE
§870.3600 Pulse Generator, External Pacemaker, Dual Chamber Class 2 OVJ
§870.3610 Implantable Pacemaker Pulse-Generator Class 3 DXY
§870.3620 Pacemaker Lead Adaptor Class 2 DTD
§870.3630 Analyzer, Pacemaker Generator Function Class 2 DTC
§870.3680 Permanent Pacemaker Electrode Class 3 DTB
§870.3680 Electrode, Pacemaker, Temporary Class 2 LDF
§870.3680 Electrode, Pacing And Cardioversion, Temporary, Epicardial Class 2 NHW
§870.3700 Programmer, Pacemaker Class 3 KRG
§870.3720 Tester, Pacemaker Electrode Function Class 2 DTA
§870.5310 Automated External Defibrillators (Non-Wearable) Class 3 MKJ
§870.5310 Over-The-Counter Automated External Defibrillator Class 3 NSA
21 CFR Part 801 Labeling, medical devices, reporting and recordkeeping requirements.
21 CFR Part 809 Labeling, medical devices.
N/A System, Esophageal Pacing Class 3 LPA
N/A Pulse-Generator, Single Chamber, Sensor Driven, Implantable Class 3 LWO
N/A Implantable Pulse Generator, Pacemaker (Non-Crt) Class 3 LWP
N/A Implantable Cardioverter Defibrillator (Non-Crt) Class 3 LWS
N/A Pulse-Generator, Single Chamber, Single Class 3 LWW
N/A Device, Removal, Pacemaker Electrode, Percutaneous Class 3 MFA
N/A Defibrillator, Implantable, Dual-Chamber Class 3 MRM
N/A System, Pacing, Temporary, Acute, Internal Atrial Defibrillation Class 3 MTE
N/A Wearable Automated External Defibrillator Class 3 MVK
N/A Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Class 3 NIK
N/A Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Class 3 NKE
N/A Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Class 3 NVN
N/A Permanent Defibrillator Electrodes Class 3 NVY
N/A Pulse Generator, Permanent, Implantable Class 3 NVZ
N/A Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode Class 3 OJX
N/A Pacemaker/Icd/Crt Non-Implanted Components Class 3 OSR
Relevant FDA Guidance and/or Supportive Publications*
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 Contact
 Robert T. Kazmierski
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.