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IMDRF/UDI WG/N48 FINAL: 2019 Unique Device Identification system (UDI system) Application Guide - PDF (3.53Mb)

赵静曼 7/6/2022 浏览 438 IMDRF/UDI WG/N48 全球

标准简介

Unique Device Identification system (UDI system) Application Guide - PDF (3.53Mb)[附网盘链接]由IMDRFUDI WG于21 March 2019发布，适用于全球。

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Unique Device Identification system (UDI system) Application Guide - PDF (3.53Mb)[附网盘链接]
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标准部分原文

Introduction

The IMDRF UDI Guidance (IMDRF/WG UDI/N7Final:2013) provides a framework for the

regulatory authorities that intend to develop their UDI systems in a globally harmonized

approach.

This UDI system Application Guide is to be used as a supplement to the IMDRF UDI

Guidance (IMDRF/WG UDI/N7Final:2013) which was developed as a high-level conceptual

framework containing the basic core concepts of a UDI system.

The document further acknowledges that additional guidance may be necessary. However, the

benefit and purpose of a UDI system will only be realized if healthcare stakeholders integrate

and obtain value in their systems from UDIs and data in associated Unique Device Identification

Databases (UDIDs). This guide is therefore also intended to assist all relevant stakeholders

within the healthcare supply chain and clinical care systems to gain a better understanding of

their role and impact on the UDI system.

1.0 Scope

This Application Guide is intended to provide the details and specifications necessary to ensure

consistency for enabling a harmonized approach in the application of the requirements set forth

in the IMDRF UDI Guidance Document (IMDRF/UDI WG/N7Final:2013).

This guide is intended to be read together with the IMDRF UDI Guidance Document

(IMDRF/UDI WG/N7Final:2013).

It is recognized that national regulations could differ in relation to certain specific aspects dealt

with in the text.

2.0 References

 IMDRF/UDI WG/N7Final: 2013 - UDI Guidance: Unique Device Identification (UDI) of

Medical Devices

 IMDRF/RPS WG/N19 Final: 2016 - Common Data Elements for Medical Device

Identification

 GS1 General Specification:

http://www.gs1.org/docs/gsmp/barcodes/GS1_General_Specifications.pdf

 GS1 Healthcare GTIN Allocation

https://www.gs1.org/docs/gsmp/healthcare/GS1_Healthcare_GTIN_Allocation_Rules.pdf

21 March 2019 Page 5 of 68

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