Usage

Bowie-Dick Test Sheet, for evaluation of air displacement and steam penetration in vacuum assisted steam sterilizers. Bowie-Dick cycles of 3.5 minutes at 134 °C or 4 minutes at 132°C.

Applicable regulation

Designed under Quality Management System standards ISO 13485:2016/NS-EN ISO 13485:2016.

ISO 11140-1:2014 and ISO 11140-3:2007

Authorization

ANMAT (Argentinean National Administration of Drugs, Food and Medical Devices) PM 1614-4.

Classification

Class 1, according to risk (ANMAT).

Characteristics

Type 2 Chemical Indicator. A4 size sheets.

Initial color: yellow

Final color: dark brown/ black

NOTE:

Air removal or steam quality and penetration problems are evidenced as a heterogeneous color change of the chemical indicator, with lighter regions in the center of the sheet.

100 % Lead Free

Environmental conditions during manufacture

T = 15-30 °C, RH = 30-80 %.

Storage conditions

T = 10-30 °C, RH = 30-80 %, keep out of direct light.

Transport conditions

Storage conditions should be strictly followed. Transport in closed and reinforced boxes in order to avoid damages. The transport of this product does not represent a risk for health.

Shelf life

5 years

Packing

50 sheets per box.

Packing information: product code and description, presentation, process for intended use, classification according to regulation, manufacturer information and data on label.

Labelling

Only on products box: product code, color change, batch number, expiration date, barcode and datamatrix code.

Possible target markets

Healthcare, Food, Pharmaceutical and Medical Industries.

Other important information

Read product’s instructions for use thoroughly before use.

Precautions

Do not store the product near sterilizing agents.

Do not expose this product to E0, Dry Heat, Radiation or any sterilization processes other than Steam.

Do not use this product for air removal monitoring of gravity displacement Steam sterilizers.

Do not use the sterilizer until the color change of the test sheet is according to the expected result, as detailed in the product reference.