YY/T 1879-2022Creation and placement of unique device identifier (English PDF)
医疗器械唯一标识的创建和赋予
This is a limited preview
Buy now to download the full PDF (24 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1879-2022 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
August 17, 2022
Implementation date
December 1, 2022
Scope
YY/T 1879-2022 is the English-translated version of 医疗器械唯一标识的创建和赋予.
YY/T 1879-2022 is the Chinese pharmaceutical industry standard that sets out how a unique device identifier is created and where it is placed on the product.
It fixes the structure of the identifier - the part that identifies the device model and the part that carries the production data such as lot, serial number and dates - the rules for the characters used and for the carrier that holds it, whether a bar code or another automatic identification technology, and where and how the carrier is applied to the device, its packaging and its label.
It is addressed to everyone who implements the identifier: manufacturers, distributors and the hospitals that read it. Issued on 17 August 2022, it has applied since 1 December 2022.
Found what you need?
Document preview — YY/T 1879-2022
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- Introduction4
- 1 Scope5
- 2 Normative references5
- 3 Terms, definitions and abbreviations5
- 4 Requirements for UDI creation6
- 5 Requirements for UDI placement links7
- 6 Requirements for the creation and placement of UDIs for certain types of medical devices10
- Bibliography12
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".
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 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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Similar standards
How to Download YY/T 1879-2022
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
YY/T 1681-2019 — Basic terms of unique device identification system
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
YY/T 0479-2026 — Medical diagnostic X-ray tube assemblies and X-ray source assemblies - Determination of maximum symmetric radiation field
Secure payment via Stripe
Payments accepted
YY/T 1879-2022
$120.00