YY/T 1879-2022 PDF English
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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/YYT1879-2022
YY
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 Contents
Foreword... 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... 12
Foreword
This 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 Scope
This 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 references
The 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 requirements
3 Terms, definitions and abbreviations
3.1 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 creation
The requirements followed in the UDI creation process are as follows.
a) UDI shall include UDI-DI and UDI-PI.
5 Requirements for UDI placement links
The requirements followed by the UDI placement link are as follows.
6 Requirements for the creation and placement of UDIs for
certain 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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