YY/T 0652-2016 in English

VALID

Wear of implant materials—Polymer and metal wear particles—Isolation and characterization

Issued on:2016-01-26
Implemented on:2017-01-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $250.00
$243.00

Standard No:	YY/T 0652-2016
Document status:	VALID
Title in English:	Wear of implant materials—Polymer and metal wear particles—Isolation and characterization
Title in Chinese:	植入物材料的磨损聚合物和金属材料磨屑分离和表征
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2016-01-26
Implemented on:	2017-01-01
Superseding:	YY/T 0652-2008 Wear of implant materials—Polymer and metal wear particles—Isolation characterization and quantification
ICS Classification:	11.040.40-Implants for surgery, prosthetics and orthotics
Chinese Classification:	C35-Orthopedic devices
Professional Classification:	YY-Pharmaceutics
Related Topics:	Polymer Characterization Polymer Characterization and Polymer Characterization Material particle size characterization Polymer Characterization Liquid Material Characterization carbon mill biological plant material plant separation polymer centrifuge Type II Implant Material biopolymer material Polymer Characterization Methods Characterization methods for metallic materials Polymer material characterization and and representation Material Characterization of Polyester Degree of polymerization characterization Implant Chemical Characterization bioseparation material Polymer Characterization Methods Polymer Characterization Methods Floristic characteristics of Kunming plant genera Mortar polymer material characterization and test methods Metal wear grade Plastic sheet wear standards Wood plant separation method

本标准规定了分离和表征聚合物和金属磨屑（磨屑来源于翻修手术或尸检时关节置换植入物周围切除的组织或关节模拟器润滑液）的仪器、试剂和试验方法。
本标准适用于植入人体和模拟器中关节置换植入物所产生的聚合物和金属材料磨屑。
本标准代替YY/T 0652-2008植入物材料的磨损聚合物和金属材料磨屑分离、表征和定量分析方法。

Introduction

Interpretation of the core content of the standard

This standard specifies a standardized method for separating and characterizing polymer/metal wear debris generated by implant wear from human tissue and joint simulator lubricating fluid. Compared with the 2008 version, the main new step for ceramic wear debris treatment (5.4) is added, and the particle number calculation requirement is deleted.

Comparison of key technologies

Wear dust type	Separation method	Characterization instrument	Key parameters
Polymer wear dust	NaOH digestion + ultracentrifugation	SEM (accelerating voltage ≤10keV)	Analysis ≥100 particles, magnification 5000-150000 times
Metal wear dust	Enzyme digestion (papain)	TEM (80kV)/SEM	Analyze 150-300 particles and classify by aspect ratio
Ceramic wear chips	Hydrochloric acid digestion method (to be verified)	EDXA composition analysis	Note acid resistance test

Key points for implementation of the standard

Typical application scenarios

In hip prosthesis revision surgery, when using an ultrasonic cell crusher (3.3.20) to process tissue samples, attention should be paid to possible contamination caused by the titanium probe. It is recommended to perform three buffer washes (step g) in accordance with clause 4.3, with a centrifugal force of 16000g to ensure the purity of the metal wear chips.

Key equipment requirements

Centrifuge: must have 100000g ultracentrifugation capacity (4.2.2.3)
Filter membrane system: equipped with 0.015μm polycarbonate membrane (3.3.14)
Electron microscope: SEM requires EDXA module, TEM slice thickness 100-120nm (4.4.2)

Technology evolution analysis

This standard is equivalent to ISO 17853:2011, and the main technological breakthroughs are reflected in:

Establish a standardized collection process for nano-scale grinding chips (<0.1μm)
Introduce density gradient centrifugation (ρ=1.02-1.35g/cm³ sucrose solution) to improve separation accuracy
Standardize the TEM/SEM dual-track verification mechanism (4.5.2)

Solutions to common problems

Problem phenomenon	Possible cause	Solution measures
Filter membrane is blocked	Grinding dust concentration is too high	Dilution is 1:10~1:100 as required by 4.4.1
SEM image is blurred	Conductive layer is too thick	Control the gold spraying thickness to 3-5nm (4.5.1)
Metal particle oxidation	Exposure to air	Use nitrogen protection throughout the process (4.3 Note 2)

More samples: JJG 21-2008 GB 50021-2001(2009) JC/T 2453-2018

Sample only — not a preview of YY/T 0652-2016

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