Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

042

Date of Entry 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

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
§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

  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/

  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

*These are provided as examples and others may be applicable.