Invisio specula have been issued with an assessment certificate of the Centre for Research and Assessment of Materials (CBT) of the Poznań University of Economics.
The testing was performed for sterile dispensable Invisio vaginal specula in XXS, XS, S, M and L sizes. The whole process was divided into two parts:
Results approved by dr inż. Karolina Assman (MSc, PhD)
Phthalate content measurement
[DEHP (CAS no 117-81-7), DBP (CAS no 84-74-2), BBP (CAS no 85-68-7), DINP (CAS 28553-12-0, 68515-48-0), DIDP (CAS 26761-40-0, 68515-49-1), DNOP (CAS 117-84-1)], method: HPLC-DAD
|Size||Production date||LOT||Phthalate content|
Strength tests in a static compression test in two variants:
– Variant A: compression force applied to bills open at maximum width, with handles locked,
– Variant B: compression force applied to handles open at maximum width, with bills closed and locked.
|Size||Production date||LOT||Mean strength under compression [kg] – Variation A||Mean strength under compression [kg] – Variation B|
|XXS||2015.10||20151010||7,36 ± 0,50||6,60 ± 0,44|
|XS||2015.10||20151010||5,56 ± 0,78||5,27 ± 0,90|
|S||2015.08||20150810||5,47 ± 0,57||7,74 ± 1,38|
|M||2015.10||20151010||7,25 ± 0,58||5,31 ± 0,78|
|L||2015.10||20151010||7,62 ± 0,70||4,49 ± 0,22|
Phthalates are salts and esters of phthalic acid. They are used e.g. in manufacturing of glycerol phthalate resins used as the foundation of phthalate varnishes and paints, glues (synthetic gum arabic) and some laminates. Also used as plasticizers. [source: Wikipedia]
Why are phthalates dangerous for human health? Phthalates disrupt the normal functioning of the hormonal system. They have adverse effect on male and female fertility and on fetal development . They may contribute to congenital defects, low birth weight, and premature labour.
They are also toxic for the kidneys and liver, and have allergenic and carcinogenic properties.
“7 year-olds whose mothers inhaled air strongly polluted with phthalates when pregnant , tend to have IQ score lower by approx. 7 points than their peers whose mothers spent their pregnancy in a setting with air relatively phthalate free.”
“Seven points on the IQ scale is a substantial difference that may affect later educational and career outcomes.”
A scientific team based at the University of Rochester, led by professor Shanna H. Swan, studied a group of pregnant women for the presence of phthalates in their urine samples. The results showed prenatal exposure to affect negatively fetal development. Decreased testosterone level in boys and disorders of sex organs development were found. [Source]
Are you concerned about the effect of harmful chemical substances on your patients’ health?
By using Invisio vaginal specula, you can rest assured they are not in harm’s way.
Our specula are entirely phthalate-free, as confirmed by the assessment of CBT Poznań, an institution specializing in research of materials used in manufacturing.