European Standard for surgical gowns and surgical drapes
This European Standard EN 13795 specifies test methods for evaluating the identified characteristics of surgical drapes, gowns and clean air suits and sets performance requirements for these medical devices.
Performance requirements
The EN 13795 have sprcific performance requirement by standard performance and high performance. And based on the risk of area of product may contact hazards, there are seperate into 2 parts ,critical area and less critical area.
To comply with EN 13795, products shall meet all the requirements specifed in following table for sugical gowns or surgical drape.
Performance Requirements for Surgical Gowns
| Charateristic | Test method | Requirement | |||
|---|---|---|---|---|---|
| Standard Performance | High Performance | ||||
| Cricital Area | Less Cricital Area | Cricital Area | Less Cricital Area | ||
| Resistance to microbial Penetration-Dry | EN ISO 22612 | Not required | ≤300 CFU | Not required | ≤300 CFU |
| Resistance to microbial Penetration-Wet | EN ISO 22610 | ≥2.8 Ib | Not required | 6.0 Ib | Not required |
| Cleanliness-Microbial | EN ISO 11737-1 | ≤300 CFU/100cm2 | ≤300 CFU/100cm2 | ≤300 CFU/100cm2 | ≤300 CFU/100cm2 |
| Cleanliness-Particulate matter | EN ISO 9073-10 | ≤3.5 IPM | ≤3.5 IPM | ≤3.5 IPM | ≤3.5 IPM |
| Linting | EN ISO 9073-10 | ≤4.0 log10 (count) | ≤4.0 log10 (count) | ≤4.0 log10 (count) | ≤4.0 log10 (count) |
| Resistance to liquid penetration | EN 20811 | ≥20 cm H2O | ≥10 cm H2O | ≥100 cm H2O | ≥10 cm H2O |
| Bursting strength-Dry | EN ISO 13938-1 | ≥40 kPa | ≥40 kPa | ≥40 kPa | ≥40 kPa |
| Bursting strength-Wet | EN ISO 13938-1 | ≥40 kPa | Not required | ≥40 kPa | Not required |
| Tensile strength-Dry | EN 29073-3 | ≥20 N | ≥20 N | ≥20 N | ≥20 N |
| Tensile strength-Wet | EN 29073-3 | ≥20 N | Not required | ≥20 N | Not required |
Performance Requirements for Surgical Drape
| Charateristic | Test method | Requirement | |||
|---|---|---|---|---|---|
| Standard Performance | High Performance | ||||
| Cricital Area | Less Cricital Area | Cricital Area | Less Cricital Area | ||
| Resistance to microbial Penetration-Dry | EN ISO 22612 | Not required | ≤300 CFU | Not required | ≤300 CFU |
| Resistance to microbial Penetration-Wet | EN ISO 22610 | ≥2.8 Ib | Not required | 6.0 Ib | Not required |
| Cleanliness-Microbial | EN ISO 11737-1 | ≤300 CFU/100cm2 | ≤300 CFU/100cm2 | ≤300 CFU/100cm2 | ≤300 CFU/100cm2 |
| Cleanliness-Particulate matter | EN ISO 9073-10 | ≤3.5 IPM | ≤3.5 IPM | ≤3.5 IPM | ≤3.5 IPM |
| Linting | EN ISO 9073-10 | ≤4.0 log10 (count) | ≤4.0 log10 (count) | ≤4.0 log10 (count) | ≤4.0 log10 (count) |
| Resistance to liquid penetration | EN 20811 | ≥30 cm H2O | ≥10 cm H2O | ≥100 cm H2O | ≥10 cm H2O |
| Bursting strength-Dry | EN ISO 13938-1 | ≥40 kPa | ≥40 kPa | ≥40 kPa | ≥40 kPa |
| Bursting strength-Wet | EN ISO 13938-1 | ≥40 kPa | Not required | ≥40 kPa | Not required |
| Tensile strength-Dry | EN 29073-3 | ≥15 N | ≥15 N | ≥20 N | ≥20 N |
| Tensile strength-Wet | EN 29073-3 | ≥15 N | Not required | ≥20 N | Not required |
