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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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