Polish assessment certificate

INVISIO SPECULA HAVE BEEN ISSUED WITH A POLISH ASSESSMENT CERTIFICATE BY THE CENTRE FOR RESEARCH AND ASSESSEMENT OF MATERIAL S (CBT – CENTRUM BADAŃ TOWAROZNAWCZYCH, previously CBi ET) IN POZNAŃ

Invisio specula – tested for phthalate content at the CBT

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:

  1. Phthalate content measurement,
  2. Strength test.

Results approved by dr inż. Karolina Assman (MSc, PhD)

NO PHTHALATE CONTENT FOUND

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
XXS 2015.10 20151010 not found
XS 2015.10 20151010 not found
S 2015.08 20151010 not found
M 2015.10 20151010 not found
L 2015.10 20151010 not found

HIGH COMPRESSION STRENGTH

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

WHY ARE PHTHALATES DANGEROUS FOR HUMAN HEALTH?

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.