by Ethan Tomas

 

HEALTH AND HYGIENE
LABORATORY

HEALTH AND HYGIENE LABORATORY

PHYSICAL, CHEMICAL AND MICROBIOLOGICAL CHARACTERISATION OF MEDICAL DEVICES

We offer all the equipment necessary to perform tests to control and improve the quality of medical devices, both woven and non-woven, reusable and single-use, in accordance with national and international technical specifications and health and safety requirements.

CAPABILITIES OF THE HEALTH AND HYGIENE LABORATORY

  • Leading Spanish laboratory in the field of medical devices

  • Consolidated experience in offering solutions to private companies, tendering companies and public administration.

  • We have unique, exclusive equipment to carry out highly specialised tests on medical devices and evaluate their performance.

  • Qualified, specialised staff in constant professional development.

HEALTH AND HYGIENE LABORATORY TESTS

CONSUMABLE SANITARY PRODUCTS

Testing of consumable medical devices: gloves, gauze, bandages, dressings, plasters, masks, hydrophilic cotton, plasters, physiological saline solution, among others.
> Characterisation of materials
> Microbiological assessment

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ensayo-absorbente

SURGERY PRODUCTS:
GOWNS, CLOTHS AND CLEAN-AIR SUITS

The evaluation of barrier properties, particle emission and resistance:
> Bacterial penetration in dry and wet environments
> Traction and bursting
> Water permeability
> Laser ignition resistance

ABSORBENT PRODUCTS FOR INCONTINENCE AND PERSONAL HYGIENE

Trials for adult and infant absorbent pants, discs, wipes, sanitary pads, cotton wool, ear swabs and other products including toothbrushes:
> Absorption capacity
> Evaluation of the moisture return
> Absorption times and speed
> Materials characterisation: strength, leachable substances, pH, composition
> Odour control
> Consumer panels
> Evaluation of comfort and breathability

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ensayo-biologico

THERAPEUTIC COMPRESSION ARTICLES AND BRACES AND ORTHOTIC PRODUCTS

> Classification and compression rates of elasticated stockings
> Consumer studies
> Elasticity and traction
> Composition and labelling
> Fre behaviour testing and biocompatibility

SYRINGES, NEEDLES, CATHETERS AND INFUSION SYSTEMS

> Resistance to penetration by a needle and the detachment of particular components
> Product function verification; Sizing and nominal volumes, measurements and grading
> Hazardous substances: particles, lubricants, extractible metals, phthalates, acidity and alkalinity

CHARACTERISATION OF PRIMARY PACKAGING OF MEDICAL DEVICES

> Determination of tightness and defects of sterile barrier medical device packaging
> Control of physical properties and harmful substances
> Sterility control

BIOLOGICAL EVALUATION STUDIES AND EXPIRATION

Biological evaluation: cytotoxicity and biocidal effectiveness, shelf life and product expiration: accelerated ageing studies; microbiological controls

DUAL PRODUCT CERTIFICATION: MEDICAL DEVICES AND EPI

AITEX is Notified Body number 0161 and issues Personal Protective Equipment (PPE) certification for gowns and gloves against chemical and biological risks (microorganisms and viruses) as category III PPE.

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LABORATORIES

We carry out tests, characterisation and quality control of products according to compliance with technical requirements and international standards

OTHER AREAS OF AITEX

AITEX provides different types of services for companies that develop products for the markets in the different textile application areas. Our services fall within the following areas.