1. Why Disposable?
Key benefits of single-use products:
Better protection against fluid strike-through
Better infection control
Higher cost benefit
Allows a leaner process in managing surgical gowns and drapes
Minimize stock management of surgical gowns and drapes through Just-In-Time deliveries
Improve OR productivity
Ease of mind with products that comply with international standards
Choice of designs that best fit the surgical requirements
2. Why Surgi-Plus?
Surgi-Plus complies with internationally recognized accreditations and standards for disposable drapes and gowns.
CERTIFICATIONS
Surgi-Plus products are certified by US FDA and European EC Certificate (CE Mark), ISO 13485, ISO 11135 (International Organization for Standardization)
BARRIER PERFORMANCE STANDARDS
All Surgi-Plus products comply to US AAMI and European EN13795 fluid barrier performance protection standardsAAMI ANSI /AAMI PB-70 : Association for the Advancement of Medical Instrumentation
EN 13795 : European Committee for Standardization
SAVE AND SAFE with premium quality and cost-efficiency
3. What is AAMI?
AAMI is the Association for the Advancement of Medical Instrumentation, an organization for advancing the development, set the safety and effective use of medical technology founded in 1965.
AAMI level is a classification system for protective apparel (such as surgical gowns), surgical drapes and drape accessories intended for use in healthcare facilities. The higher the AAMI level, the higher the protection offered by the protective product. i.e. The higher the AAMI level, the better protection for the healthcare professionals against infections through the transfer of micro-organisms, body fluids and particulate matters.
AAMI 1: Minimal level of fluid barrier protection
AAMI 2: Low level of fluid barrier protection
AAMI 3: Moderate level of fluid barrier protection
AAMI 4: Highest level of fluid and viral barrier protection
Level |
Test |
Result |
AAMI 1 |
AATCC 42 Water Impact (WI) |
<,= 4.5 g |
AAMI 2 |
AATCC 42, WI AATCC 127 Hydro Head (HH) |
<,= 1.0 g >,= 20 cm |
AAMI 3 |
AATCC 42, WI AATCC 127 (HH) |
<,= 1.0 g >,= 50 cm |
AAMI 4 |
ASTM F1671, Gowns ASTM F1670, Drapes |
Pass Pass |
ASTM F1671- Penetration test by blood borne pathogens using Phi-X174 bacteriophage penetration.
ASTM F1670- Penetration test for Resistance of materials by synthetic blood.