Standard No.:	YY/T 1863-2023
English Name:	Biological evaluation for nanomaterial medical devices--Testing andcharacterization methods for silver nanoparticles and ions released fromsilver nanoparticle containing dressing
Chinese Name:	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
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.30 11.040.30    Surgical instruments and materials 11.040.30
Source Content Issued by:	State Drug Administration
Issued on:	2023-01-13
Implemented on:	2024-1-15
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	9500 words
Translation Price(USD):	285.0
Delivery:	via email in 1 business day

YY/T 1863-2023 Biological evaluation for nanomaterial medical devices - Testing and characterization methods for silver nanoparticles and ions released from silver nanoparticle-containing dressing 1 Scope This document specifies the test methods to evaluate the silver nanoparticles and ions released from silver nanoparticle-containing dressings in the release medium, as well as the separation, determination and characterization of silver nanoparticles and ions in the release fluid. This document is applicable to the evaluation of the release characteristics of silver nanoparticles and ions of silver nanoparticle-containing dressing in contact with body surface wounds. 2 Normative references The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 6682 Water for analytical laboratory use - Specification and test methods GB/T 36083 Nanotechnology - Silver nanomaterials - Guidance for the characterization of biological effect-related physicochemical properties GB/T 38261-2019 Nanotechnology - Determination of silver contents in biological samples - Inductively coupled plasma mass spectrometry ISO 19430 Particle size analysis - Particle tracking analysis (PTA) method ISO/TS 19590 Nanotechnologis - Size distribution and concentration of inorganic nanoparticles in aqueous media via single particle inductively coupled plasma mass spectrometry Pharmacopoeia of the People's Republic of China 3 Terms and definitions For the purposes of this document, the terms and definitions given in GB/T 36083, GB/T 38261-2019 and the following apply. 3.1 silver nanoparticle-containing dressing woven or non-woven fabrics containing silver nanoparticles, which are used as composite materials for surface coverage and wound protection and control the microbial environment of the dressing and/or wound through the antibacterial and/or bactericidal properties of the silver nanoparticles in the dressing, creating favorable conditions for wound healing Note: Dressings which have a metabolic, pharmacological or immunological interaction as their primary intent are excluded. 3.2 simulated body fluid; SBF inorganic solution similar in composition to human plasma and containing no organic components 4 Abbreviations For the purposes of this document, the following abbreviations apply.

Foreword i Introduction ii 1 Scope 2 Normative references 3 Terms and definitions 4 Abbreviations 5 Release testing of silver nanoparticles and ions 6 Measurement of total silver content and silver ion content in the release solution 7 Characterization of silver nanoparticles in the release solution 8 Test report Annex A (Informative) Reciprocating holder method Annex B (Informative) Testing on recovery of silver ions in simulated body fluids Bibliography