This European Standard EN13795 gives information on the characteristics of single-use and reusable surgical gowns, non woven surgical drapes and clean air suits used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures. This European Standard specifies test methods for evaluating the identified characteristics of surgical drapes, gowns and clean air suits and sets performance requirements for these products.
Performance requirements:
To comply with EN 13795, products shall meet all the requirements specifed in either Tables 1 or 2 (as appropriate to the product), when tested according to this European Standard throughout their useful life.
Table 1 - Characteristics to be evaluated and performance requirements for surgical gowns
|
Characteristic |
Test method (for references, see Clause 2) |
Unit |
Requirement |
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|
Standard performance |
High performance |
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|
Critical product area |
Less critical product area |
Critical product area |
Less critical product area |
|||
|
Resistance to microbial Penetration-Dry |
EN ISO 22612 |
CFU |
Not required |
≤300ɑ
|
Not required |
≤300ɑ |
|
Resistance to microbial penetration-Wet |
EN ISO 22610 |
IB |
≥2.8b |
Not required |
6.0 b c |
Not required |
|
Cleanliness-Microbial |
EN ISO 11737-1 |
CFU/100cm2 |
≤300 |
≤300 |
≤300 |
≤300 |
|
Cleanliness-Particulate matter |
EN ISO 9073-10 |
IPM |
≤3.5 |
≤3.5 |
≤3.5 |
≤3.5 |
|
Linting |
EN ISO 9073-10 |
log10(lint count) |
≤4.0 |
≤4.0 |
≤4.0 |
≤4.0 |
|
Resistance to liquid penetration |
EN 20811 |
cm H2O |
≥20 |
≥10 |
≥100 |
≥10 |
|
Bursting strength - Dry |
EN ISO 13938-1 |
kPa |
≥40 |
≥40 |
≥40 |
≥40 |
|
Bursting strength - Wet |
EN ISO 13938-1 |
kPa |
≥40 |
Not required |
≥40 |
Not required |
|
Tensile strength - Dry |
EN 29073-3 |
N |
≥20 |
≥20 |
≥20 |
≥20 |
|
Tensile strength - Wet |
EN 29073-3 |
N |
≥20 |
Not required |
≥20 |
Not required |
|
A. Test conditions: challenge concentration 108 CFU/g talc. and 30 min vibration time. B. The Least Significant Difference (LSD) for IB when estimated using EN ISO 22610, was found to be 0.98 at the 95 % confidence level. This is the minimum difrence needed to ditinguish between two materials thought to be different. Thus materials varying by up to 0.98 IB are probably not different; materials varying by more than 0.98 IB probably are diferent (The 95 % confidence levels means that an observer would be correct 19 times out of 20 to accept these alternatives.) C. IB=6.0 for the purpose of this European Standard means: no penetration. IB= 6.0 is the maximum achievable value. |
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Table 2 - Characteristics to be evaluated and performance requirements for surgical drapes
|
Characteristic |
Test method (for references, see Clause 2) |
Unit |
Requirement |
|||
|
Standard perfomance |
High performance |
|||||
|
Critical product area |
Less critical product area |
Critical product area |
Less critical product area |
|||
|
Resistance to microbial Penetration-Dry |
EN ISO 22612
|
CFU |
Not required |
≤300ɑ |
Not required |
≤300ɑ |
|
Resistance to microbial penetration-Wet |
EN ISO 22610 |
IB |
≥2.8b |
Not required |
6.0 b c |
Not required |
|
Cleanliness-Microbial |
EN ISO 11737-1 |
CFU/100cm2 |
≤300 |
≤300 |
≤300 |
≤300 |
|
Cleanliness-Particulate matter |
EN ISO 9073-10 |
IPM |
≤3.5 |
≤3.5 |
≤3.5 |
≤3.5 |
|
Linting |
EN ISO 9073-10 |
log10(lint count) |
≤4.0 |
≤4.0 |
≤4.0 |
≤4.0 |
|
Resistance to liquid penetration |
EN 20811 |
cm H2O |
≥30 |
≥10 |
≥100 |
≥10 |
|
Bursting strength - Dry |
EN ISO 13938-1 |
kPa |
≥40 |
≥40 |
≥40 |
≥40 |
|
Bursting strength - Wet |
EN ISO 13938-1 |
kPa |
≥40 |
Not required |
≥40 |
Not required |
|
Tensile strength - Dry |
EN 29073-3 |
N |
≥15 |
≥15 |
≥20 |
≥20 |
|
Tensile strength - Wet |
EN 29073-3 |
N |
≥15 |
Not required |
≥20 |
Not required |
|
A. Test conditions: challenge concentration 108 CFU/g talc. and 30 min vibration time. B. The Least Significant Difference (LSD) for IB when estimated using EN ISO 22610, was found to be 0.98 at the 95 % confidence level. This is the minimum difrence needed to ditinguish between two materials thought to be different. Thus materials varying by up to 0.98 IB are probably not different; materials varying by more than 0.98 IB probably are diferent (The 95 % confidence levels means that an observer would be correct 19 times out of 20 to accept these alternatives.) C. IB=6.0 for the purpose of this European Standard means: no penetration. IB= 6.0 is the maximum achievable value. |
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NOTE 1: Performance requirements are specified depending on product area and perfomance level. However for some characteristics the performance requirement will apply for all performance levels and product areas of the medical device.
NOTE 2: Information on characteritics, which cannot be properly evaluated (as 'adhesion for fixation for the purpose of wound isolation' or liquid control) or which are not regarded normative (as 'comfort) is given.
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