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non-active surgical implants determination method mammary implants introductionthis standard gel-filled breast implants implants oligomeric siloxanes seed quality requirements china test items definition test method scope remanufactured camshafts
YY/T 1457-2016 in English

YY/T 1457-2016 in English

VALID

Non-active surgical implants—Determination method for oligomeric siloxanes in mammary implants

  • Issued on:2016-01-26
  • Implemented on:2017-01-01
  • File Format:PDF
  • Delivery:Via email within 1~3 business days
Price(USD): $160.00
$156.00
Standard No: YY/T 1457-2016
Document status: VALID
Title in English: Non-active surgical implants—Determination method for oligomeric siloxanes in mammary implants
Title in Chinese: 无源外科植入物硅凝胶填充乳房植入物中寡聚硅氧烷类物质测定方法
Language: English
File Format: Electronic (PDF)
Delivery: Via email within 1~3 business days
Issued on: 2016-01-26
Implemented on: 2017-01-01
ICS Classification: 11.040.40-Implants for surgery, prosthetics and orthotics
Chinese Classification: C45-Extracorporeal circulation, artificial organ and prosthesis device
Professional Classification: YY-Pharmaceutics
Related Keywords: non-active surgical implants determination method
mammary implants introductionthis standard
gel-filled breast implants
implants
oligomeric siloxanes
Related Topics: plant silicon
Silane Determination Method
botanical origin detection method
Implantation program
Implantation program
Inorganic silicon substance
of silanized substances
plant energy
plant energy
Plant Root Determination Method
Silane + Substance
Determination of plant-like silicon
PLA Implants
Inorganic Carbon in Plants
silicon in plants
Silanized substance
Implantable wireless charging
plant silica
Lactide monomer in polylactic acid materials for surgical implants
silicone silicone
Plant specimen fixation methods
Determination method of plant total nitrogen
National standard for testing method of silicone gel rate
Plant explant research methods
Silicone detection method
Plant gel extraction method
surgical implant polymer
Plant exosome verification method
Total carbon determination in plants

本标准规定了测定乳房植入物中小分子残留物的浸提液制备原则、测定方法、结果分析、许可限量等。
本标准适用于硅凝胶填充的乳房植入物。


Introduction

This standard provides a method for the determination of oligosiloxane substances in silicone gel-filled breast implants, which are a type of medical device. It outlines the procedures and techniques necessary for the accurate analysis of these substances. The standard specifies the equipment, reagents, and conditions required for the testing process. It also includes details on sample preparation and analytical procedures. The content is structured to ensure consistency and reliability in the testing process. The standard is intended for use by laboratories and manufacturers involved in the production and quality control of such medical devices.

*** Please note: This description may not be accurate, please refer to the official documentation.

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