YY/T 1863-2023Biological evaluation of nanomaterial medical devices - Testing and characterization methods for the release of nano-silver particles and silver ions from nano-silver dressings (English PDF)
纳米医疗器械生物学评价 含纳米银敷料中纳米银颗粒和银离子的释放与表征方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
January 13, 2023
Implementation date
January 15, 2024
Scope
YY/T 1863-2023 is the English-translated version of 纳米医疗器械生物学评价 含纳米银敷料中纳米银颗粒和银离子的释放与表征方法.
YY/T 1863-2023 is the Chinese standard "Biological evaluation of nanomaterial medical devices - Testing and characterization methods for the release of nano-silver particles and silver ions from nano-silver dressings".
Its scope clause reads: This document specifies the experimental method for evaluating the release of nano-silver particles and silver ions from dressings containing nano-silver in the release medium, as well as the release solution.
Separation, determination and characterization methods of medium and nano silver particles and silver ions. This document is applicable to the evaluation of the release characteristics of nano-silver particles and silver ions of nano-silver dressings that are in contact with body surface wounds. Its clauses include terms and definitions; abbreviations.
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Document preview — YY/T 1863-2023
National Standard of the People's Republic of China
- ICS
- 11.040.30
Issued by: National Medical Products Administration
Contents
- Preface
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Abbreviations
- 5 Release experiment of nano-silver particles and silver ions
- 6 Measurement of total silver content and silver ion content in release solution
- 7 Characterization of silver nanoparticles in release solution
- 8 Experiment Report
- Appendix A (informative) Reciprocating support method
- Appendix B (informative) Experiment of recovery rate of silver ions in simulated body fluid
1 Scope
This document specifies the experimental method for evaluating the release of nano-silver particles and silver ions from dressings containing nano-silver in the release medium, as well as the release solution.
Separation, determination and characterization methods of medium and nano silver particles and silver ions.
This document is applicable to the evaluation of the release characteristics of nano-silver particles and silver ions of nano-silver dressings that are in contact with body surface wounds.
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 6682 Analytical laboratory water specifications and test methods
GB/T 36083 Guidelines for Characterization of Physicochemical Properties Related to Biological Effects of Nanotechnology Silver Nanomaterials
GB/T 38261-2019 Nanotechnology measurement of silver content in biological samples Inductively coupled plasma mass spectrometry (PTA) method]
ISO /T S19590 Nanotechnology Measurement of Inorganic Nanoparticles in Aqueous Media by Single Particle Inductively Coupled Plasma Mass Spectrometry
Pharmacopoeia of the People's Republic of China
3 Terms and Definitions
GB/T 36083, GB/T 38261-2019 and the following terms and definitions apply to this document.
3.1
Woven or non-woven fabric containing nano-silver particles, used for body surface covering and wound protection combination materials, through the nano-silver particles in the dressing
Antibacterial and/or bactericidal properties can be used to control the microbial environment of dressings and/or wounds, and create favorable conditions for wound healing.
NOTE. Dressings with predominantly metabolic, pharmacological or immunological effects are not included.
3.2 simulated body fluid simulated body fluid; SBF
An inorganic solution similar in composition to human blood plasma without organic components.
4 Abbreviations
The following abbreviations apply to this document.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 6682Water for analytical laboratory use - Specification and test methods
- GB/T 36083Nanotechnology - Silver nanomaterials - Guidance for the characterization of biological effect-related physicochemical properties
- GB/T 38261-2019Nanotechnology - Determination of silver content in biological samples
Similar standards
HJ 1198|GJB 1763
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Related Standards
GB/T 36083-2018 — Nanotechnology - Silver nanomaterials - Guidance for the characterization of biological effect-related physicochemical properties
GB/T 38261-2019 — Nanotechnology - Determination of silver content in biological samples
GB/T 6682-2008 — Water for analytical laboratory use - Specification and test methods
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