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The Medical Devices Directive 2007/47/EC amending 93/42/EEC stipulates that from 21 March 2010 onwards, device containing phthalates logo shall be affixed if parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain below phthalates.

If the device contains phthalates which are classified as carcinogenic, mutagenic or toxic for reproduction, of category 1 or 2, in accordance with Annex I of Directive 67/548/EEC, these devices must be labelled on the device itself and/or packaging for each unit or, where appropriate, on the sales packaging according to the requirement of EN 15986:2011 of EU standard (shown below)

Directive 67/548/EEC has been updated to EU No1272/2008, which involves totally 8 phthalates as shown in Table 1.

In order to help our clients addressing this requirement,we are pleased to offer the phthalates testing service.

table 1: Phthalates Testing Services on Medical Devices in SGS

Testing itemtesting standardtattesting price
a. DEHP (CAS#117-81-7)
b. DBP (CAS#84-74-2)
c. BBP (CAS#85-68-7)
d. DPP (CAS#131-18-0)
e. DMEP (CAS#177-82-8)
f. DiPP (CAS#605-50-5)
g. DIBP (CAS#84-69-5)
h. nPiPP (CAS# 84777-06-0)
i. 1,2-Benzenedicarboxylic acid, dipentylester, branched and linear (CAS#84777-06-0)
EN 14372:2004
5-7 working days HKD 1,200/material
For further information, please contact: 

E&E Technology CS Team
t: +852 2765 3617
f: +852 2766 3778

Get a copy in PDF version: SGS Offers Medical Devices Phthalates Testing Services (PDF 179 KB)