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Phthalates in medical devices

日期: 2020-06-10

Medical device refers to any instrument, device, appliance, material or other object intended by the manufacturer for use in the human body, whether used alone or in combination, including software required for its normal use.


A: Disease diagnosis, prevention, surveillance, treatment or mitigation

B: Diagnosis, monitoring, treatment or mitigation of injury or disability

C: Exploration, substitution, or alteration of anatomical or physiological processes

D: Birth control



In September 2007, the EU issued the new Medical Devices Directive 2007/47/EC as a revision to the previous Directive 93/42/EEC

Part 7.5 of the Directive:


 If part of the medical device (or the device itself) is expected to be used for drugs, body fluids, or other material management, and/or to inject the above substances into the body, or remove them from the body, or to transport or store such body fluids or substances, if such device contains carcinogenic, mutagenic, or with reproductively toxic phthalates in Class 1 or 2 Annex I of 67/548/EEC (this Directive has been updated to No. 1272/2008) Directive, such device itself and/or its individual packaging and the sales packaging, if applicable, must be labeled with ‘phthalates containing’.


Directive 67/548/EEC updated Directive No.1272/2008, in which there are nine phthalates involved as follows:

 

DEHP

di (2-ethyl hexyl) phthalate

117-81-7

DBP

Dibutyl phthalate

84-74-2

BBP

Butyl benzyl phthalate

85-68-7

DPP

Dipentyl phthalate

131-18-0

DMEP

Diphthalate (2-methoxyethyl) ester

117-82-8

DIPP

Di-iso-pentyl phthalate

605-50-5

DIBP

Diisobutyl phthalate

84-69-5

nPiPP

N-amyl isoamyl phthalate

776297-69-9

C5-PHTH

1, 2-phenolic acid - bis (branched and straight-chain) amyl ester

84777-06-0



Test Method: EN14372:2004


Test Equipment:Gas chromatography-mass spectrometer (GC-MS)


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