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YY/T 1879-2022: Creation and placement of unique device identifier Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
YY/T 1879-2022: Creation and placement of unique device identifier---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1879-2022YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040 CCS C 30 Creation and placement of unique device identifier Issued on. AUGUST 17, 2022 Implemented on. DECEMBER 01, 2022 Issued by. National Medical Products Administration Table of ContentsForeword... 3 Introduction... 4 1 Scope... 5 2 Normative references... 5 3 Terms, definitions and abbreviations... 5 4 Requirements for UDI creation... 6 5 Requirements for UDI placement links... 7 6 Requirements for the creation and placement of UDIs for certain types of medical devices... 10 Bibliography... 12ForewordThis document was drafted in accordance with the rules given in GB/T 1.1-2020 "Directives for standardization - Part 1.Rules for the structure and drafting of standardizing documents". Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights. This document was proposed by National Medical Products Administration. This document shall be under the jurisdiction of Medical Device Standard Management Center of National Medical Products Administration. The drafting organizations of this document. General Hospital of the Chinese People's Liberation Army, Medical Device Standard Management Center of the State Drug Administration, BD Medical Devices (Shanghai) Co., Ltd., Shenzhen Mindray Biomedical Electronics Co., Ltd., Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine. Main drafters of this document. He Kunlun, Yi Li, Mei Guojiang, Li Meng, Wang Xinbing, Song Kejing, Lu Yuanyuan, Shen Lei, Zhang Nan, Ren Jing.1 ScopeThis document specifies the requirements for creation and placement of unique device identifier. This document is applicable to the implementation and application of the unique device identifier by all relevant parties.2 Normative referencesThe following referenced documents are indispensable for the application 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 ISO 15223-1.2021, Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1.General requirements3 Terms, definitions and abbreviations3.1 Terms and definitions For the purposes of this document, the terms and definitions defined in YY/T 1681 apply. 3.2 Abbreviations The following abbreviations apply to this document.4 Requirements for UDI creationThe requirements followed in the UDI creation process are as follows. a) UDI shall include UDI-DI and UDI-PI.5 Requirements for UDI placement linksThe requirements followed by the UDI placement link are as follows.6 Requirements for the creation and placement of UDIs forcertain types of medical devices 6.1 Medical device package The requirements for the medical device package to be followed in the creation and placement of UDI are as follows. 6.2 Independent software The independent software follows the following requirements in the process of UDI creation and placement. 6.3 Implanted device Implanted devices follow the following requirements in the UDI creation and placement process. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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