標(biāo)準(zhǔn)編號(hào):	YY/T 1943-2024
中文名稱:	醫(yī)療器械唯一標(biāo)識(shí)的包裝實(shí)施和應(yīng)用
英文名稱:	UDI implementation and application in medical device package levels
行業(yè)分類:	YY    醫(yī)藥行業(yè)標(biāo)準(zhǔn)
發(fā)布機(jī)構(gòu):	國家藥品監(jiān)督管理局
發(fā)布日期:	2024-07-08
實(shí)施日期:	2025-7-20
標(biāo)準(zhǔn)狀態(tài):	to be valid
翻譯語言:	英文
文件格式:	PDF
中文字符數(shù):	23000 字
翻譯價(jià)格(元):	1610.0
交付時(shí)間:	付款后 1 個(gè)工作日

YY/T 1943-2024 UDI implementation and application in medical device package levels 1 Scope This document specifies the UDI implementation in various medical device packaging levels and its resolution in the supply chain. This document is applicable to the UDI implementation and application in in medical device with multi-level packaging. 2 Normative references The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. YY/T 1681 Basic terms of unique device identification system YY/T 1752 Basic data set of unique device identification database YY/T 1753 Reporting guide of unique device identification database YY/T 1942 Form and content of the unique device identifier 3 Terms, definitions and abbreviations 3.1 Terms and definitions For the purposes of this document, the terms and definitions given in YY/T 1681 apply. 3.2 Abbreviations For the purposes of this document, the following abbreviations apply. AIDC: Automatic Identification and Data Capture HRI: Human Readable Information UDI: Unique Device Identifier UDID: Unique Device Identification Database UDI-DI: Unique Device Identifier-Device Identifier UDI-PI: Unique Device Identifier-Production Identifier UoU UDI-DI: Unit of Use Unique Device Identifier-Device Identifier 4 General 4.1 Packaging in this document refers to the packaging level of the products contained therein with the same minimum sales unit UDI-DI and production batch No. Note: For a packaging level, the quantity of medical devices is fixed. 4.2 The packaging levels do not apply to shipping container, and see examples of packaging levels and shipping container in Annex A. Note: From the perspective of traceability, the shipping container itself can be traced in the logistics system without the need of UDI. 4.3 The composition of UDI-PI for different packaging levels of medical devices with the same specification and model should be consistent.

Foreword i Introduction ii 1 Scope 2 Normative references 3 Terms, definitions and abbreviations 4 General 5 UDI implementation in package 6 Resolution of each packaging level in the supply chain Annex A (Informative) Examples of packaging levels and shipping containers Annex B (Informative) Conversion and resolution of multi-level packaging in case of the minimum sales unit containing one unit of use Annex C (Informative) Conversion and resolution of the minimum sales unit and the unit of use Annex D (Informative) Example of recording product consumption in case of no UDI data carrier for the unit of use Bibliography