Table 5.8.

Performance requirements for surgical gowns (EN 13795–3)

Characteristic	Standard performance		High performance
	Critical area	Less critical area	Critical area	Less critical area
Resistance to microbial penetration–dry (log10 CFU)	N/A	≤2a,c	N/A	≤2a,c
Resistance to microbial penetration–wet (BI)	≥2.8b	N/A	6.0b,d	N/A
Cleanliness–microbial (log10 CFU/dm2)	≤2c	≤2c	≤2c	≤2c
Cleanliness–particulate matter (IPM)	≤3.5	≤3.5	≤3.5	≤3.5
Linting (log10 lint count)	≤4.0	≤4.0	≤4.0	≤4.0
Resistance to liquid penetration (cm H2O)	≥20	≥10	≥100	≥10
Bursting strength–dry (kPa)	≥40	≥40	≥40	≥40
Bursting strength–wet (kPa)	≥40	N/A	≥40	N/A
Tensile strength–dry (N)	≥20	≥20	≥20	≥20
Tensile strength–wet (N)	≥20	N/A	≥20	N/A

The 95% confidence level means that an observer would be correct 19 times out of 20 to accept these alternatives.

^aTest conditions: challenge concentration 10⁸ CFU/g talc. and 30 min vibration time.

^bThe least significant difference for BI when estimated using EN ISO 22610 was found to be 0.98 at the 95% confidence level. This is the minimum difference needed to distinguish between two materials thought to be different. This means materials varying by up to 0.98 BI are probably not different; materials varying by more than 0.98 BI probably are different.

^cFor the purpose of this standard, log₁₀ CFU ≤ 2 means maximum 300 CFU.

^dBI = 6.0, for the purpose of this standard, means no penetration. BI = 6.0 is the maximum achievable value.