Certified surgical masks

CE marked products
in accordance with Regulation (EU) n. 2017/745

ISO 22609:2004 certification,
ISO 10993-5 and ISO 10993-10

Production in accordance with
technical standard UNI EN 14683:2019

EFFICIENCY AND STRENGTH

The Diamant Surgical Face Mask are constantly tested to ensure the highest degree of protection and efficiency.

Test	REGULATORY REFERENCE	RESULT
EFFICIENCY OF BACTERIAL FILTRATION (BFE), (%)	UNI EN 14683:2019	FILTRATION EFFICIENCY AVERAGE BACTERIAL 99,8%
DIFFERENTIAL PRESSURE (Pa/cm2)	UNI EN 14683:2019	AVERAGE VALUE 46,4 Pa/cm2
MICROBIAL CLEANING (cfu/g)	UNI EN 14683:2019	AVERAGE VALUE 9,27 (cfu/g)
PRESSURE OF SPLASH RESISTANCE (KPa)	UNI EN 14683:2019; ISO 22609:2004	PRESSURE 21 KPa

BIOCOMPATIBILITY

According to the ISO 10993-1 standards, the Diamant Surgical Face Mask has been tested for biocompatibility with fabrics: devices in contact with the skin for an extended contact time.

DEFECTS DETECTED	BY LEGISLATION	METHOD OF VERIFICATION	SAMPLING PLAN	ACCEPTABLE QUALITY LEVEL
CYTOTOXICITY	ISO 10993-5	In vitro	SAMPLE	BIOCOMPATIBLE
SENSITISATION	ISO 10993-5	In vitro	SAMPLE	BIOCOMPATIBLE
IRRITATION	ISO 10993-5	In vitro	SAMPLE	BIOCOMPATIBLE

TECHNICAL DOCUMENTATION TO BE DOWNLOADED

DECLARATION OF CONFORMITY

DATA SHEET

SPLASH RESISTANCE

CYTOTOXICITY

USABILITY

Safe srl v1

Safe srl v2

TECHNICAL FILE

INFORMATION

Do you need assistance or contact the sales department?