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Database: 365,228(8 Aug 2026)
medical devices medical devices scopethis standard plasticizer dehp devices dehp industrial filters process specifications implementation multi-hinged ladders
YY/T 0927-2014 in English

YY/T 0927-2014 in English

VALID

Guidance of determination for di(2-ethylhexyl) phthalate(DEHP) released from PVC medical devices

  • Issued on:2014-06-17
  • Implemented on:2015-07-01
  • File Format:PDF
  • Delivery:Via email within 1~3 business days
Price(USD): $140.00
$136.00
Standard No: YY/T 0927-2014
Document status: VALID
Title in English: Guidance of determination for di(2-ethylhexyl) phthalate(DEHP) released from PVC medical devices
Title in Chinese: 聚氯乙烯医疗器械中邻苯二甲酸二(2-乙基己基)酯(DEHP)溶出量测定指南
Language: English
File Format: Electronic (PDF)
Delivery: Via email within 1~3 business days
Issued on: 2014-06-17
Implemented on: 2015-07-01
ICS Classification: 11.040.30-Surgical instruments and materials
Chinese Classification: C31-General and microsurgical devices
Professional Classification: YY-Pharmaceutics
Related Keywords: medical devices
medical devices scopethis standard
plasticizer dehp
devices
dehp
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xylene in styrene
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本标准适用于DEHP为增塑剂的医用聚氯乙烯制造的医疗器械在使用中DEHP溶出量的测定。
本标准规定了在模拟实际使用条件下,以聚氯乙烯(PVC)为原料制成的医疗器械与临床使用液体接触后,增塑剂DEHP溶出量测定的化学分析方法。


Scope

This standard provides a chemical analysis method for the determination of the dissolution of the plasticizer DEHP after medical devices made of polyvinyl chloride (PVC) as raw materials come into contact with clinical liquids under simulated actual use conditions.

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