YY/T 1953-2026Biological evaluation of nanomaterial medical devices - Test for antimicrobial performance (English PDF)
纳米医疗器械生物学评价 抗菌性能试验
This is a limited preview
Buy now to download the full PDF (14 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1953-2026 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 9, 2026
Implementation date
March 1, 2027
Scope
YY/T 1953-2026 is the English-translated version of 纳米医疗器械生物学评价 抗菌性能试验.
YY/T 1953-2026 is the Chinese standard "Biological evaluation of nanomaterial medical devices - Test for antimicrobial performance".
Its scope clause reads: This document describes the testing methods for the antibacterial properties of medical devices using nanomaterials, including the agar plate diffusion method, absorption method, and vibration method.
Swaying method. This document applies to the evaluation of the antibacterial properties of medical devices that utilize nanomaterials. Note 1.Currently, this mainly includes medical devices containing nanomaterials that come into contact with wounds on the body surface.
Note 2.Currently, this document mainly provides test methods for antibacterial performance. Test methods for bactericidal performance will be considered for inclusion in this document once the technology matures. Its clauses include terms and definitions.
Found what you need?
Document preview — YY/T 1953-2026
National Standard of the People's Republic of China
- ICS
- 11.040.30
- Classification
- C30
Issued by: National Medical Products Administration
Contents
- Preface
- Introduction
- 1.Scope
- 2 Normative References
- 3.Terms and Definitions
- 4.Main equipment, experimental materials, reagents, and their preparation
- 5.Test methods for evaluating antibacterial properties
- 6 Test Report
- Appendix A (Normative) Plate Counting Method
- References
1 Scope
This document describes the testing methods for the antibacterial properties of medical devices using nanomaterials, including the agar plate diffusion method, absorption method, and vibration method.
Swaying method.
This document applies to the evaluation of the antibacterial properties of medical devices that utilize nanomaterials.
Note 1.Currently, this mainly includes medical devices containing nanomaterials that come into contact with wounds on the body surface.
Note 2.Currently, this document mainly provides test methods for antibacterial performance. Test methods for bactericidal performance will be considered for inclusion in this document once the technology matures.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.
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.
This document.
YY/T 1477.1 Standard test models for evaluating the performance of contact wound dressings – Part 1.Evaluation of antimicrobial activity in vitro for wounds
Model
Pharmacopoeia of the People's Republic of China (2020 Edition)
Disinfection Technical Specifications (2002 Edition)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 nanomaterials
Materials whose external dimension, internal or surface structure is in the size range of 1nm to 100nm.
[Source. GB/T 30544.4-2019, 2.3, with modifications]
3.2 antimicrobial
The process of killing bacteria and fungi or inhibiting their growth, reproduction and activity using chemical or physical methods.
[Source. Disinfection Technical Specifications (2002 Edition), 1.3.30, with modifications]
3.3 Colony forming unit (CFU)
In live bacteria culture counting, colonies are formed by the growth and reproduction of single bacteria or multiple bacteria aggregated together on a solid culture medium.
Note. It is used to express the number of live bacteria.
3.4 test sample
The samples prepared from medical device products using nanomaterials contain a corresponding proportion of nanomaterial components.
3.5 control sample
Except for the absence of nanomaterial components, it is consistent with the test sample (3.4).
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 14 pages — is available in the English PDF.
Referenced standards
How to Download YY/T 1953-2026
- 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
YY/T 1477.1-2016 — Standard test models for primary wound dressing performance evaluation - Part 1: In vitro wound model for antimicrobial activity evaluation
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 1953-2026
$225.00