YY/T 1406-2026Medical device software - Guidance on the application of GB/T 42062 to medical device software (English PDF)
医疗器械软件 GB/T 42062应用于医疗器械软件的指南
This is a limited preview
Buy now to download the full PDF (50 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1406-2026 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 9, 2026
Implementation date
March 1, 2027
Scope
YY/T 1406-2026 is the English-translated version of 医疗器械软件 GB/T 42062应用于医疗器械软件的指南.
YY/T 1406-2026 is the Chinese standard "Medical device software - Guidance on the application of GB/T 42062 to medical device software". Its scope clause reads: This document provides guidance on applying the requirements contained in GB/T 42062-2022 to the medical device software referred to in YY/T 0664-2020.
This document provides guidelines for software components (standalone software and software components). It does not add to or change GB/T 42062-2022 or YY/T 0664-2020.
Require. This document applies to medical device software as defined in YY/T 0664-2020.This document also applies to applications requiring security risk management.
All software in the healthcare environment, regardless of whether it is classified as a medical device. This document does not apply to. --Production or quality management system software; --Software development tools. Its clauses include terms and definitions.
Found what you need?
Document preview — YY/T 1406-2026
National Standard of the People's Republic of China
- ICS
- 11.040.01
- Classification
- C30
- Replacing
- YY/T 1406.1-2016
Issued by: National Medical Products Administration
Contents
- Preface
- Introduction
- 1.Scope
- 2 Normative References
- 3.Terms and Definitions
- 4.General Requirements for Risk Management Systems
- 4.1 Risk Management Process
- 4.2 Management Responsibilities
- 4.3 Personnel Capabilities
- 4.4 Risk Management Plan
- 4.5 Risk Management Documents
- 5.Risk Analysis 9.
- 5.1 Risk Analysis Process
- 5.2 Intended Use and Reasonably Foreseeable Misuse
- 5.3 Identification of safety-related characteristics
- 5.4 Identification of Hazards and Hazardous Situations
- 5.5 Risk Assessment
- 6.Risk Assessment
- 7.Risk Control
- 7.1 Risk Control Plan Analysis
- 7.2 Implementation of Risk Control Measures
- 7.3 Residual Risk Assessment
- 7.4 Benefit-Risk Analysis
- 7.5 Risks arising from risk control measures
- 7.6 Integrity of Risk Control
- 8.Comprehensive Residual Risk Assessment
- 9.Risk Management Review
- 10 Production and Post-Production Activities
- 10.1 General Provisions
- 10.2 Information Collection
- 10.3 Information Review
- 10.4 Measure
- Appendix A (Informative) Discussion of Definitions
- Appendix B (Informative) Example 29 of Software-Related Causes
- Appendix C (Informative) Potential Software-Related Risks
- Appendix D (Informative) Life Cycle/Risk Management Matrix
- Appendix E (Informative) Security Use Case
- References
1 Scope
This document provides guidance on applying the requirements contained in GB/T 42062-2022 to the medical device software referred to in YY/T 0664-2020.
This document provides guidelines for software components (standalone software and software components). It does not add to or change GB/T 42062-2022 or YY/T 0664-2020.
Require.
This document applies to medical device software as defined in YY/T 0664-2020.This document also applies to applications requiring security risk management.
All software in the healthcare environment, regardless of whether it is classified as a medical device.
This document does not apply to.
--Production or quality management system software;
--Software development tools.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are listed below.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
document.
GB/T 42062-2022 Application of Medical Device Risk Management to Medical Devices
YY/T 0664-2020 Medical Device Software Life Cycle Process
3 Terms and Definitions
The terms and definitions defined in GB/T 42062-2022 and YY/T 0664-2020, as well as the following terms and definitions, apply to this document.
3.1 diversity
A form of redundancy in which redundant elements use different (diverse) components, technologies, or methods to reduce the common causes that lead to all the desired results.
The probability of all elements failing simultaneously.
3.2 Redundancy
Provide multiple components or mechanisms to accomplish the same function, so that the failure of one or more components or mechanisms will not prevent the function from being executed.
3.3 Safety-related software
Software that can lead to dangerous situations, or software used to implement risk control measures.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 50 pages — is available in the English PDF.
Referenced standards
Similar standards
Editions of YY/T 1406
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 1406-2026 | Medical device software - Guidance on the application of GB/T 42062 to medical device software | current edition | Current |
| YY/T 1406.1-2016 | Medical device software - Guidance on the application of GB/T 42062 to medical device software | previous edition | In force until 2027-03-01 |
This page sells the current edition, YY/T 1406-2026. Earlier editions are listed for reference only.
How to Download YY/T 1406-2026
- 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
GB/T 42062-2022 — Medical devices - Application of risk management to medical devices
YY/T 0664-2020 — Medical device software—Software life cycle processes
YY/T 1406.1-2016 — Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
Secure payment via Stripe
Payments accepted
YY/T 1406-2026
$785.00