YY/T 1960-2025 Pending Industry standards-Medicine

YY/T 1960-2025 Medical devices—Information to be supplied by the manufacturer

Publish Date: 2025-06-18 Implement Date: 2026-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1960-2025

Standard Type: Industry standards

Standard Status: Pending

is_force_gb: no

CCS Name: Medical devices

ICS Name: Integrated medical equipment

Publish Date: 2025-06-18

Implement Date: 2026-07-01

Pages: 40 pages

Scope

This document specifies the requirements for the information provided by manufacturers of medical devices or accessories. This document includes general requirements for marking and labeling on the medical devices or accessories themselves and their packaging, as well as for the marking of medical devices or accessories and accompanying information. This document does not specify the method of providing information.
The requirements specified in medical device product standards or professional standards take precedence over the requirements of this document.
Note 1: Guidelines or explanations for this chapter can be found in Appendix A, section A.2.
Note 2: Certain regulatory authorities with jurisdiction may have requirements for the marking, labeling, and accompanying documents of medical devices or accessories that differ from the requirements of this document.

Development Information

Word Count: 65 Thousand words Pages: 40 pages

Referenced Standards

GB/T 2659.1-2022 Codes for the representation of names of countries and their subdivisions—Part 1:Country code GB/T 2893.1-2004 Graphical symbols—Safety Colors and safety signs—Part1:Design principles for safety signs in workplaces and public areas GB/T 2893.1-2013 Graphical symbols—Safety colours and safety signs—Part 1:Design principles for safetry signs and safety markings GB/T 7408.1-2023 Date and time—Representations for information interchange—Part 1:Basic rules GB/T 42061-2022 Medical devices—Quality management systems—Requirements for regulatory purposes GB/T 42062-2022 Medical devices—Application of risk management to medical devices YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements ISO 7000 ISO 7010:2019 ISO 80000-1 IEC 60417 IEC 62366-1:2015

Adopt standards

ISO 20417:2021

Related Standards

GB/T 16886.11-1997 Replaced

GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

Publish Date: 1997-06-26

GB/T 16886.3-1997 Replaced

GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity

Publish Date: 1997-06-26

GB/T 16886.6-1997 Replaced

GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

Publish Date: 1997-06-26

GB/T 16886.1-2001 Replaced

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing

Publish Date: 2001-09-24

GB/T 16886.13-2001 Replaced

GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices

Publish Date: 2001-09-24

GB/T 16886.7-2001 Replaced

GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals

Publish Date: 2001-09-24