SURGICAL SOLUTIONS:

SURGICAL DRAPES & GOWNS

EN 13795

YOUR HALYARD HEALTH

GUIDE TO THE EUROPEAN
STANDARD EN 13795

A COMMON LANGUAGE TO COMPARE EN 13795 SPECIFIES REQUIREMENTS FOR

PRODUCT PERFORMANCE SINGLE-USE AND REUSABLE SURGICAL
Standards for medical devices aim at improving
DRAPES (INCLUDING EQUIPMENT
the quality of the products on the market and
COVERS AS STERILE FIELD), SURGICAL
are therefore vital for good clinical practice.
GOWNS AND CLEAN AIR SUITS.
The standard sets out the technical requirements
The European Standard EN 13795 is the first
of the products, responsibilities of manufacturers,
standard for users and suppliers of single-use
processes and provides information for the use of
and multiple-use products, with mutually agreed
their devices, intended to prevent the transmission
test methods to be applied to all fabrics on
of infective agents between patients and clinical
the market, irrespective of their construction.
staff during surgical and other invasive procedures.
This standard provides an excellent tool for users
to compare product performance. EN 13795 is In order to comply with EN 13795, the devices
an EU recognized harmonized standard. have to meet a number of technical requirements
as demonstrated by the following test conditions.
BARRIER
RESISTANCE TO DRY MICROBIAL PENETRATION (EN ISO 22612)
Objective: determine the ability of the dry
fabric to resist penetration of particles carrying Test Performance Requirements (CFU)
micro-organisms. STANDARD PERF. HIGH PERF.

Method: the test fabric is placed in a container C LC C LC

with talc contaminated with Bacillus subtilis. Gown - ≤300 - ≤300
Any talc that penetrates the fabric is captured Drape - ≤300 - ≤300
on a sedimentation plate underneath and
incubated.
Measure: number of colonies formed after incubation.

RESISTANCE TO WET MICROBIAL PENETRATION (EN ISO 22610)

Objective: determine a fabric’s resistance to
penetration of bacteria in a liquid while being Test Performance Requirements (IB)
subjected to mechanical rubbing. STANDARD PERF. HIGH PERF.

Method: the test fabric is subjected to material C LC C LC

contaminated with Staphylococcus aureus Gown ≥2,8 - 6,0 -
suspension. If penetration occurs, bacteria Drape ≥2,8 - 6,0 -
will collect on to an agar surface and be
incubated.
Measure: number of colonies formed after incubation, expressed in Barrier Index (BI).

RESISTANCE TO LIQUID PENETRATION (EN 20811)

Objective: estimate the resistance of fabrics to
liquid penetration by water under constantly Test Performance Requirements (cm H20)
increasing hydrostatic pressure. STANDARD PERF. HIGH PERF.

Method: one side of the fabric sample is C LC C LC

subjected to purified water pressure which Gown ≥20 ≥10 ≥100 ≥10
is increased at a constant rate until leakage Drape ≥30 ≥10 ≥100 ≥10
appears on the other side of the fabric sample.
Measure: the head height results are recorded
in centimeters of water pressure on the fabric sample.

CLEANLINESS
CLEANLINESS – MICROBIAL (EN ISO 11737-1)
Objective: estimate the bioburden or number
of viable micro-organisms on a product prior Test Performance Requirements (Cfu/100 cm2)
to sterilisation. STANDARD PERF. HIGH PERF.
Method: stomaching method – C LC C LC
EN ISO 11737-1 B.2.2.1. Gown ≤300 ≤300 ≤300 ≤300
Measure: number of colonies formed
Drape ≤300 ≤300 ≤300 ≤300
(per dm2).
LINTING
CLEANLINESS – PARTICULATE MATTER & LINTING (ISO 9073-10)

CLEANLINESS – PARTICULATE MATTER

Objective: estimate linting of the fabric in a
dry state, prior to twisting and compressing. Test Performance Requirements (IPM)
Method: fabric is placed in a chamber and STANDARD PERF. HIGH PERF.
number particles are calculated.
C LC C LC
Measure: number of particles from 3μm to
Gown ≤3.5 ≤3.5 ≤3.5 ≤3.5
25 μm, as an index for Particulate Matter (PM)
Drape ≤3.5 ≤3.5 ≤3.5 ≤3.5
expressed as log10.

LINTING
Objective: estimate linting of the fabric in a
Test Performance Requirements
dry state, after twisting and compressing.
(log10 (lint count))
Method: the same fabric sample is twisted and
STANDARD PERF. HIGH PERF.
compressed.
Measure: number of particles from 3μm C LC C LC
to 25μm generated after the twisting and Gown ≤4.0 ≤4.0 ≤4.0 ≤4.0
compressing, expressed as log10 of the count Drape ≤4.0 ≤4.0 ≤4.0 ≤4.0
value.

STRENGTH
BURSTING STRENGTH – DRY & WET (EN 13938-1)
Objective: determine the resistance of a fabric
to puncture under dry and wet conditions. Test Performance Requirements( kPA)
Method: a fabric sample is clamped over an STANDARD PERF. HIGH PERF.
expansive diaphragm by means of a circular C LC C LC
ring. Fluid pressure is applied at a constant Gown ≥40 ≥40* ≥40 ≥40*
rate on the other side of the diaphragm
Drape ≥40 ≥40* ≥40 ≥40*
causing distension of the diaphragm and
not required for wet
*

fabric until the fabric bursts.

Measure: strength at burst, in kPA.

TENSILE STRENGTH – DRY & WET (EN 29073-3)

Objective: determine the ability of a product
to withstand fabric tearing under dry and wet Test Performance Requirements (N)
conditions. STANDARD PERF. HIGH PERF.
Method: a strip (specified length and width) C LC C LC
of fabric is held in place with clamps on a Gown ≥20 ≥20 *
≥20 ≥20*
machine that pulls the strip apart at a constant
Drape ≥15 ≥15* ≥20 ≥20*
rate of extension.
*
not required for wet
Measure: amount of force applied to break
the strip, in Newton.

C = Critical Area LC = Less Critical Area


CRITICAL OR LESS
CRITICAL AREA?
At Halyard Health, we define
the Critical Area (A) as:
• The chest and the sleeves
(from cuff to elbow) for
gowns
• The (reinforced) area around
the fenestration for drapes
The other parts are considered
as Less Critical Areas (B)
www.halyardhealth.uk
WHAT IS THE SIGNIFICANCE OF EN 13795 ON HEALTHCARE FACILITIES
THAT ACQUIRE SINGLE-USE OR MULTIPLE-USE GOWNS AND DRAPES
FROM EXTERNAL SUPPLIERS?
As always, the healthcare facility should verify that the device is CE marked
(i.e. meets the requirements of the Medical Device Directive). Should the
manufacturer claim compliance to EN 13795, the customer can request the
test data.
ARE HOSPITALS OBLIGED TO PURCHASE DEVICES THAT COMPLY WITH
THE STANDARD?
No, as standards are in itself voluntary, manufacturers have the choice
to determine their own conformity assessment route. However, in the
case of EN 13795, most manufacturers claim compliance to the standard.
Customers are always advised to request documentation on performance
from all manufacturers independently from them claiming compliance to
EN 13795 or not.
WHAT FACTORS DOES A HOSPITAL HAVE TO CONSIDER WHEN
CHOOSING DRAPES AND GOWNS?
If hospitals utilize products that are not in compliance with applicable
European or International standards, they would need to substantiate their
decision, and the burden of proof is upon the hospital in the event of an
inspection, a medical complaint or any other issues. Therefore, in terms of
product liability hospitals would want to use products/devices that comply
with International or European standards.
ALL HALYARD* DRAPES AND GOWNS EXCEED
THE MINIMUM PROPOSED PERFORMANCE
REQUIREMENTS LISTED IN EN 13795
For more than 40 years, Halyard Health (formerly known as Kimberly-
Clark) has been recognized as a leader in the development of surgical
fabrics of outstanding performance and reliability, with over 650
patents registered for advanced nonwoven fabrics. When choosing
HALYARD* Surgical Drapes and Gowns, you know you’re getting a
trusted clinical solution for a wide range of surgical procedures.
For more information, please send an email to
customerservice.uk.ie@hyh.com or visit www.halyardhealth.co.uk.
* Registered Trademark or Trademark of Halyard Health, Inc. or its affiliates. ©2015 HYH. All rights reserved. HC519-02-UK