Standard: AAMI - 15223-1

MEDICAL DEVICES — SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELING, AND INFORMATION TO BE SUPPLIED — PART 1: GENERAL REQUIREMENTS

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Scope:

This part of ISO 15223 identifies requirements for symbols used in medical device labeling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this part of ISO 15223.

This part of ISO 15223 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.

These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of this part of ISO 15223 are not intended to apply to symbols specified in other standards.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: 15223-1
Publish Date: 2012-01-01
Page Count: 38
Change Type: COMPLETE REVISION
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
15223-1 Change Type: STCH Update Date: 2007-01-01 Status: INAC
15223-1 Change Type: Update Date: 2007-01-01 Status: INAC
15223-1 Change Type: Update Date: 2007-01-01 Status: INAC

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