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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 042 Date of Recognition 06/15/2016 
FR Recognition Number 3-132
Standard
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
U.S. 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
Scope/Abstract
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
Unclassified Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Class 3 NIK
Unclassified Defibrillator, Implantable, Dual-Chamber Class 3 MRM
Unclassified Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode Class 3 OJX
Unclassified Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Class 3 NVN
Unclassified Pacemaker/Icd/Crt Non-Implanted Components Class 3 OSR
Unclassified Permanent Defibrillator Electrodes Class 3 NVY
Unclassified Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Class 3 NKE
Unclassified Pulse Generator, Permanent, Implantable Class 3 NVZ
Unclassified System, Pacing, Temporary, Acute, Internal Atrial Defibrillation Class 3 MTE
Unclassified Wearable Automated External Defibrillator Class 3 MVK
§870.5310 Automated External Defibrillators (Non-Wearable) Class 3 MKJ
§870.5310 Over-The-Counter Automated External Defibrillator Class 3 NSA
§870.3720 Tester, Pacemaker Electrode Function Class 2 DTA
Unclassified Implantable Cardioverter Defibrillator (Non-Crt) Class 3 LWS
Unclassified Implantable Pulse Generator, Pacemaker (Non-Crt) Class 3 LWP
Unclassified Pulse-Generator, Single Chamber, Sensor Driven, Implantable Class 3 LWO
§870.3700 Programmer, Pacemaker Class 3 KRG
Unclassified Device, Removal, Pacemaker Electrode, Percutaneous Class 3 MFA
Unclassified System, Esophageal Pacing Class 3 LPA
§870.3680 Electrode, Pacemaker, Temporary Class 2 LDF
§870.3680 Electrode, Pacing And Cardioversion, Temporary, Epicardial Class 2 NHW
§870.3680 Permanent Pacemaker Electrode Class 3 DTB
§870.3630 Analyzer, Pacemaker Generator Function Class 2 DTC
§870.3620 Pacemaker Lead Adaptor Class 2 DTD
Unclassified Pulse-Generator, Single Chamber, Single Class 3 LWW
§870.3610 Implantable Pacemaker Pulse-Generator Class 3 DXY
§870.3600 Pulse Generator, External Pacemaker, Dual Chamber Class 2 OVJ
§870.3600 Pulse-Generator, Pacemaker, External Class 3 DTE
§870.1750 Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) Class 2 JOQ
21 CFR 801 Labeling, medical devices, reporting and recordkeeping requirements.
21 CFR 809 Labeling, medical devices.
Relevant FDA Guidance and/or Supportive Publications
No relevant guidance developed at this time.
FDA Technical Contact
 Robert T. Kazmierski
  FDA/OMPT/CDRH/ODE/DCD/IEDB/
  301-796-5447
  Robert.Kazmierski@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Cardiovascular
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