Overview

This standard specifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that correspond with the requirements of this standard. The standard 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 underlying international document (ISO 15223-1:2012) has been prepared by Technical Committee ISO/TC 210 "Quality management and corresponding general aspects for medical devices" in collaboration with Technical Committee CEN/CLC/TC 3 "Quality management and corresponding general aspects of medical device" (secretariat: NEN, Netherlands) with the participation of German experts. The committee responsible for this standard is NA 063-01-13 AA "Qualitätsmanagement und entsprechende allgemeine Aspekte für Medizinprodukte" ("Quality management and corresponding general aspects for medical devices") at DIN.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-01-02 AA - Quality management and corresponding general aspects for medical devices  

Responsible european committee

CEN/CLC/JTC 3 - Quality management and corresponding general aspects for medical devices