Liquid barrier performance & classification of Protective Apparel for use in Health Care facilities

The ANSI/AAMI PB 70:2012 standard establishes minimum barrier performance requirements, a classification system and associated labelling requirements for protective apparel, surgical drapes, and drape accessories intended for use in health care facilities.

The classification system places protective apparel, either disposable or re-usable into levels of barrier performance. The four levels essentially measure the level of resistance to fluid penetration.

The levels measure increasingly higher levels of protection with Level 1 offering protection against liquids that may splash onto the user up to Level 4 offering resistance to liquid and viral penetration.

Level 1 – Minimal protection against liquid splashing

Level 2 – Low level of protection toward liquid impact and liquid penetration

Level 3 – Moderate level of protection toward liquid impact and liquid penetration

Level 4 – High level of protection toward liquid and viral penetration

AWTA Product Testing has the capability to test up to and including Level 3.

There are two tests required for level classification namely:

AATCC 42 – Water Resistance: Impact Penetration Test

This test measures the resistance to water penetration by impact or splashing.

AATCC 127 – Water Resistance: Hydrostatic Pressure Test

This test measures the resistance to water penetration under hydrostatic pressure or under a water column.

The table below shows performance requirements for level classification.

   

ANSI/AAMI PB 70:2012 identifies critical zones to be tested for compliance.

Critical Zones of a gown intended for surgical applications.

 

 

NOTE: Diagram extracted from ANSI/AAMI PB 70:2012

Critical zones on gowns intended for isolation applications

NOTE: Diagram extracted from ANSI/AAMI PB 70:2012

The standard also specifies a sampling plan for testing based on a statistical Acceptable Quality Level (AQL) and Rejectable Quality Level (RQL):

• AQL – 4%
• RQL – 20%

The number of tests to be performed to classify the Level of bulk goods is therefore dependent upon:

• Lot size
• Inspection type
• General Inspection Level

For full details of the testing procedures and sampling plan, please refer to ANSI/AAMI PB70:2012.

Labelling Requirements

Each surgical gown, other item of protective apparel, surgical drape, and drape accessory shall be clearly labelled with its level of barrier performance, as determined by the testing procedures.

Testing

AWTA Product Testing can offer single item product development type testing or bulk testing.

Talk to our consultants for a pricing plan as this may vary somewhat depending upon the number of garments that the sample plan dictates to be tested.

Phone: (03) 9371 2400 or Email: [email protected]