En 868-6 Medicals Norma Europeia
En 868-6 Medicals Norma Europeia
En 868-6 Medicals Norma Europeia
NORME EUROPENNE
EUROPISCHE NORM
ICS 11.080.30; 55.040
EN 868-6
June 1999
English version
Packaging materials and systems for medical
devices which are to be sterilized
Part 6: Paper for the manufacture of packs for medical use for
sterilization by ethylene oxide or irradiation
Requirements and tests methods
CEN
European Committee for Standardization
Comit Europen de Normalisation
Europisches Komitee fr Normung
Central Secretariat: rue de Stassart 36, B-1050 Brussels
Contents
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Requirements
Annex A (normative)
repellency
Annex B (normative)
size
Annex C (informative)
Annex D (informative)
Bibliography
Foreword
This European Standard has been prepared by Technical
Committee CEN/TC 102 Sterilizers for medical purposes, the
secretariat of which is held by DIN.
EN 868-1
EN 868-3
EN 868-4
EN 868-5
EN 868-6
EN 868-7
EN 868-8
for
steam
sterilizers
conforming
to
EN
285
Introduction
Part 1 of this series of European standards specifies general
requirements and test methods for all packaging materials and
1 Scope
This Part of the series of EN 868 provides examples of particular
requirements and test methods for paper used in the manufacture of
packs for medical use.
The paper specified in this part of the series EN 868 is suitable for
the manufacture of packages to be used in ethylene oxide or
irradiation sterilization processes.
Paper specified in this Part of the series EN 868 is intended for use
in part or complete manufacture of pouches and form and fill packs
and lidding material for packs.
2 Normative references
This European Standard incorporates, by dated or undated
reference, provisions from other publications. These normative
references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent
amendments to or revisions of any of these publications apply to this
European Standard only when incorporated in it by amendment or
revision. For undated references, the latest edition of the publication
referred to applies.
EN 868-1
EN 20187
EN 20535
EN 21974
EN 28601
Data
elements
and
interchange
formats
ISO 535
ISO 2758
ISO 3869
ISO 3781
ISO 5636-3
ISO 6588
aqueous extracts
ISO 9197-1
ISO 9198
3 Definitions
For the purposes of this European Standard, the definitions of EN
868-1 apply.
4 Requirements
4.1
General
4.2. Materials
4.2.1 Raw materials used for the manufacture of packaging
materials may be virgin or reclaimed materials provided that the
source, history and traceability of all raw materials, especially
recycled materials, are known and controlled to ensure that the
finished product will consistently meet the requirements of this
standard.
NOTE: With current commercial technologies it is unlikely that
reclaimed material other than manufacturing waste will be
sufficiently controlled to allow its safe use for medical device
packaging.
4.2.2 The pulp shall be free from grit and untreated fragments of the
original materials from which the pulp was prepared.
4.3 Conditioning
Where reference is made in the following performance requirements
to conditioned paper or to the need for conditioning prior to
carrying out a test the paper shall be conditioned in accordance with
the method given in EN 20187.
4.4.8 When tested in accordance with 2.5 of DIN 58953-6: 1987 the
paper shall neither exhibit an increase in brightness due to the
optical brightener of more than 1% nor have more than five
fluorescent spots, each having an axis greater than 1 mm per 0,01
m.
4.4.10 The air permeance of the conditioned paper shall be not less
than 0,2 m/Pa s and not more than 6,0 m/Pa s when tested in
accordance with ISO 5636-3.
4.4.12 The wet bursting strength of the paper shall be not less than
35 kPa when tested in accordance with ISO 3689 using an
immersion time of 10 min.
4.4.13 The water repellency of the paper shall be such that the
penetration time is not less than 20 s. when tested in accordance
with Annex A .
4.4.15 The tensile strength of the conditioned paper shall be not less
than 4,0 kN/m in machine direction and not less than 2,0 kN/m in
cross direction when tested in accordance with ISO 1942-2.
4.4.16 The wet tensile strenght of the paper shall be not less than
0,80 kN/m in machine direction and not less than 0,40 kN/m in corss
direction when tested in accordance with ISO 3781.
Annex A (normative)
Method for the determination of water repellency
A.1 Apparatus
A.1.1 An ultra-violet light source and light meter as described in DIN
58953-6 : 1987.
A.1.3 Desiccator.
A.1.4 Stopwatch.
A.2 Reagent
Dry indicator powder prepared as described below.
Grind 20 g of sucrose in a mortar and pass through a sieve of
nominal aperture size 0,063 mm to 0,075 mm. Dry the sieved
sucrose in a desiccator over silica gel or in an oven at 105 C to
110 C. Mix 10 g of the dry sucrose with 10 mg of sodium
A.3 Procedure
Take 10 test pieces of conditioned paper, each of size 60 mm x 60
mm. Separate the samples into two groups of five, one group with
the wire-side uppermost and the other with the top-side
uppermost. For each sample make two folds, each 10 mm high at
right angles along two edges. Fill the flat dish with purified water at
the conditioning temperature to a depth of 10 mm. Switch on the UV
lamp and allow it to develop full output and adjust the distance of the
lamp so that the irradiance at the level of the water in the dish is
(300 20) W/cm. Sprinkle the upper surface of a test piece thinly
with indicator powder from the dispenser. Float the test piece on the
water under the UV light source and note the time taken for a
general fluorescence to appear. Repeat the procedure with the
remaining nine test pieces.
Annex B (normative)
Method for the determination of pore size
B.1 Principle
The pressure required to force air bubbles through the interstices of
a material, wetted by a liquid and having a film of the same liquid
applied to its upper surface, is observed. This pressure together with
the known surface tension of the liquid is used to estimate the size
of the interstices in the material.
B.3 Apparatus
B.3.1 The apparatus is shown diagrammatically in figure B.1. The
principal parts are as follows:
a) The testing head (1): a cylindrical vessel of an appropriate
material (e. g. brass) over which the specimen a can be
clamped by a clamping ring b and screw c. It is fitted with a
synthetic rubber gasket d of 50 mm internal diameter to make a
seal against the specimen.
b) Pressure measuring device.
c) A stop-valve which serves to direct air to the testing head.
d) A variable flow valve set to give the required rate of rise of
pressure in 1.
e) A stop-valve which directs air to the pressure measuring device.
f) Air reservoir of about 2,5 l capacity connected to 1. This
ensures that the rate of flow of air necessary to maintain the
required rise of pressure is so large that the loss of air through
the material when bubbling begins will not reduce the rate of rise
of pressure.
g) The air supply.
B.3.2 Using the apparatus shown in figure B.1 the test is conducted
as follows:
Turn on the air supply. Open valve 3 to direct air to the test head
via reservoir 6, and adjust valve 4 to give the required rate of
pressure rise. Leave stop-valve 5 open during testing. When the
first bubble appears in the test material, 5 is closed to allow the
pressure reached to be read from the measuring device 2.
________________
) 1 mm head of water + 9,80 655 Pa.
B.5 Procedure
B.5.1 Conduct the test in the standard atmosphere for testing
specified in EN 20187.
NOTE: Very open material can be more easily tested if the air
pressure is allowed to increase on the underside of the specimen
and bulge the specimen before the test liquid is poured on to cover
the surface of the material completely.
B.6 Results
B.6.1 Calculation and expression of results
Calculate the equivalent pore radius r in micrometres for each
specimen by means of the equation:
r = 2 T . 10/pPg
Or simplified
r = 204 . T/P
where:
T is the surface tension of the test liquid at the temperature of the
test, in mN/m;
g is the acceleration due to gravity, in mm/s;
p is the density of water at the temperature of the test, in mg/mm;
P is the bubble pressure, in millimetres head of water.
1 Testing head
a specimen
b clambing ring
c screw
d rubber gasket
6 Air reservoir
7 Air supply
Figure B.1: Diagrammatic representation of the apparatus for
the determination of the pore size
Annex C (informative)
Dimensions and tolerances
The dimensions of the sheets and width of rolls should be in
accordance with those given by the supplier for sterilization
packaging. The following tolerances should apply:
- Nominal size up to 1000 mm: 5mm;
- Nominal size > 1.000 mm: 10 mm;
- Roll lenght: 5%.
Annex D (informative)
Bibliography
ISO 8791-2
Paper and board Determination of roughness/smoothness (air leak
methods) Part 2: Bendtsen method