HEALTH AND HYGIENE PRODUCTS

Medical Devices evaluation

Physical, chemical and microbiological characterisation  medical devices in compliance with national and international health and safety technical specifications and requirements.

SURGICAL:

• Surgical dressings and apparel, single-use and reusable clean-air suits: Resistance to penetration against bacteria in dry and wet, linting, breaking resistance.
• Surgical masks: Resistance to blood penetration, respirability, bacterial filtration efficiency, biological control.
• Sutures: caharacterization, resistance, antimicriobal effectiveness.
• Medical gloves: Surgical and exploration: Breaking strenght, extractable proteins, verification of AQL, Penetration resistance against virus with synthetic blood.
• Consumables: gauzes, bandages, dressings, hydrophilic cotton, plaster, physiological saline solution: composition control, water vapour permeability, absorbency, fluid absorption, impermeability, linting test.

ABSORBENT PRODUCTS FOR INCONTINENCE AND PERSONAL HYGIENE:

Tests for: adult and baby diapers, discs, wipes, sanitary pads, cotton wool, ear swabs and other products including toothbrushes:

• Absorption capacity, evaluation of the moisture return, absorption time and speed.

• Materials characterization: resistance, leachable substances, pH, composition.
• Odour control studies: urine neutralization.
• Comfort evaluation: transpirability, ergonomics, softness (Kawabata) and noise evaluation.
• Consumer panels.
• Analysis of principal ingredients.

THERAPEUTIC COMPRESSION ARTICLES AND BRACES AND ORTHOTIC PRODUCTS:

• Classification and compression rates of elasticated stockings. Consumer studies.
• Elasticity and breaking streght materials, before and after washing.
• Composition and labelling.
• Fire behaviour testing and biocompatibility.

SYRINGES, NEEDLES, CATHETERS AND INFUSION SYSTEMS:

• Resistance to penetration by a needle and detachment of particular components of a product.
• Sizing and nominal volumes, measurements and grading.
• Product verification function.
• Hazardous subtances: particles, lubricants, extractable heavy methals, phtalates, acidity and alkalinity.

CERTIFICATION OF DUAL PRODUCTS: MEDICAL DEVICES AND INDIVIDUAL PROTECTION EQUIPMENTS (PPE)

In its capacity as a Notifying Body for PPE´s (Nº 0161) offers services for the certificatiion, production control and labeling for dual medical devices. There are many medical devices that are dual products: protection of the patient from external infection and also protect the worker against biological and chemical risks.

BIOLOGICAL EVALUATION AND EXPIRATION DATE STUDIES

A full service for all types of materials and finished goods:

• Biological evaluation of the product in contact with skin: citotoxicity and biocide evaluation.
• Shelf life and product expiration: using accelerated ageing studies.
• Microbial control in product and in manufacturing environments.

 

PUBLIC TENDERS FOR THE HEALTHCARE SECTOR

Collaboration with companies, Public Administrations, Health Services of CCAA and Hospitals, for the elaboration specific conditions of Hospital Supplies.

Aditionally to the product testing above, also it is tested:  Hospital linen and clothing (for patients and medical staff) and detergents for hospital laundry tenders.