The Quality Connection

Antimicrobialcables and systems

for medical devices

Antimicrobial LEONI cables and systems are equipped with

a germicidal plastic surface that is effective against both

gram-positive and gram-negative bacteria (including mul-

tiresistant pathogens such as MRSA, VRE and ESBL), as well as

viruses and moulds.

The addition of only a small quantity of a metal oxide* to the

sheath material significantly reduces contamination to > 99.99%

on the surface. During normal handling (involving contact with

sweat and proteins), the antimicrobial effect is retained well,

throughout a range of times and concentrations. This is an

important difference to conventional methods using silver or

copper.

Nor do cleaning procedures typically used in hospitals impact

the effectiveness of this technique. Since the antimicrobial sub-

stance is physically incorporated into the plastic medium, it is

non-soluble in water, acids, bases and alcohols, and is heat-re-

sistant to 250 °C. The substance does not induce resistance.

Long-lasting antimicrobial protection

Lewis acid-base theoryAcid ions are released at the cable’s surface by a special metal oxide* contained in the sheath material. These ions cause a drop in pH on the cable’s outer surface – similar to the protective acidic mantle on human skin.

* The active antimicrobial ingredient used by LEONI is licensed as a biocide

by the European Commission and released pursuant to Article 94.

Acid ions

Metal oxides

pH value 0 14

NeutralStrong acid Efficiency zone

Strong base

74e.g. gastric acid e.g. surface of skin

AntimicrobialLEONI products

Business Unit Healthcare offers its customers an integrated

range of products and services that extends from engineer-

ing and cable design through to complex cable systems

with integrated mechanical and electronic components.

For equipment cabling, LEONI can draw on over 700 separate

UL-certified styles.

For applications with patient contact, LEONI offers a broad

spectrum of cables and systems, featuring biocompatible and

antimicrobial surfaces. When used to supplement existing

hygiene standards, antimicrobial products from LEONI can

help to reduce the microbial load in healthcare facilities.

Smart solutions for medical devices

Antimicrobial, skin-friendlycables and systems

ECG

Emergency room

Operating theatre,endoscopy and

catheter systems

Patient room

Dentaltechnology

Ultrasound

The antimicrobial effectiveness of LEONI’s products

has been tested across a broad spectrum of microbes

and materials:

TEST DESCRIPTION The test sample (a piece of cable

approx. 4 cm in length) is inoculated with 109 CFU*/ml for

6 hours. The test sample is then rolled over a blood agar

plate every 3 hours,and the plate is then incubated at 37 °C.

ANALYSIS OF PHOTOGRAPHIC RECORDS After 3 hours,

a significant drop in microbial load can be seen. Over time –

6 to 12 hours, depending on the microbe – pathogens are

no longer present on the cable surface.

NOTES ON THE TEST METHOD The results obtained with

this method are in agreement with results from practical tests

conducted on the surface across a range of times and concen-

trations. Where contamination is marginal, the microbial

load drops considerably faster. This method not only

describes the biostatic and biocidal effects on

single organisms but also assesses microbial

adherence and biofilm formation. The block -

ing of these two factors is decisive for the

elimination of microbes on surfaces.

Scientifically-proven effectiveness

0h 3h 6h 9h 12h

Staphylococcus aureus MRSAATCC 25923

Escherichia coli ATCC 27020

Pseudomonas aeruginosa ATCC 10145

* CFU = colony-forming units

In manufacturing its cable systems for medical devices, LEONI

uses a variety of semi-automated injection moulding and casting

techniques for the processing of thermoplasts, thermoplastic

elastomers and liquid silicone rubber (LSR). For applications with

patient contact, LEONI exclusively uses biocompatible materials

in cable extrusion and overmoulding processes.

Hygienic and skin-friendly

The efficacy of LEONI’s antimicrobial products has been

certified by Quality Labs BT. Testing is conducted to confirm

DIN EN ISO 10993-5 and 10993-10 biocompatibility for custom-

ised material formulations used in antimicrobial cables and sys-

tems with patient contact. Side effects such as toxicity, allergicity

or irritation to human skin have not been observed.

Due to its medium grain size (> 1 μm), the metal oxide

is not classified as a (controversial) nanotechnology.

Silicone cables from LEONI are latex-free, BSE/TSE-compliant

(no substances of animal origin) and contain no phthalates

or Bisphenol A.

Due to their individual design, moulded plugs, grommets

and v-splitters have high mechanical stability. The avoidance

of grooves and cavities in transitional areas also prevents

the formation of dangerous biofilms.

Our cables areboth REACH- andROHS2-compliant

ETFE SiliconeTPUFEP *

* LEONI currently produces antimicrobial and biocompatible cables and systems

of different thermoplastic polyurethanes (TPU).

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Business Unit Healthcare

LEONI Special Cables GmbH

Eschstrasse 1

26169 Friesoythe

Germany

Phone +49 4491 291 5040

Healthcarewww.healthcare.com healthcare@leoni.com