YY/T 1406-2026 English, YY/T 1406-2026 Medical device software - Guidance on the application of GB/T 42062 to medical device software (English)

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Position: Chinese Standard in English/YY/T 1406-2026

YY/T 1406-2026 Medical device software - Guidance on the application of GB/T 42062 to medical device software (English)
Standard No.:	YY/T 1406-2026	Status:	to be valid remind me the status change Email:
Target Language:	English	File Format:	PDF
Word Count:	29500 words	Translation Price(USD):	885.0 remind me the price change Email:
Implemented on:	2027-3-1	Delivery:	via email in 1~8 business day

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Standard No.:	YY/T 1406-2026
English Name:	Medical device software - Guidance on the application of GB/T 42062 to medical device software
Chinese Name:	医疗器械软件 GB/T 42062应用于医疗器械软件的指南
Professional Classification:	YY Professional Standard - Pharmaceutics
Source Content Issued by:	National Medical Products Administration
Issued on:	2026-03-09
Implemented on:	2027-3-1
Status:	to be valid
Superseding:	YY/T 1406.1-2016 Medical device software—Part 1:Guidance on the application of ISO 14971 to medical device software
Target Language:	English
File Format:	PDF
Word Count:	29500 words
Translation Price(USD):	885.0
Delivery:	via email in 1~8 business day

Standard

YY/T 1406-2026 Medical device software - Guidance on the application of GB/T 42062 to medical device software (English Version)
Standard No.	YY/T 1406-2026
Status	to be valid
Language	English
File Format	PDF
Word Count	29500 words
Price(USD)	885.0
Implemented on	2027-3-1
Delivery	via email in 1~8 business day

Detail of YY/T 1406-2026

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Introduction of YY/T 1406-2026

本文件提供了将GB/T 42062-2022中包含的要求应用于YY/T 0664-2020中所指的医疗器械软件（独立软件和软件组件）的指南，本文件不增加或改变GB/T 42062-2022或YY/T 0664-2020的要求。
本文件适用于YY/T 0664-2020中所指的医疗器械软件。本文件还适用于需要实施安全风险管理过程的医疗保健环境中的所有软件，而无论其是否被归类为医疗器械。
本文件不适用于：生产或质量管理体系软件；软件开发工具。

Contents of YY/T 1406-2026


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