SIST ENV 12718:2002

SLOVENSKI STANDARD
01-maj-2002
Medicinske kompresijske nogavice
Medical compression hosiery
Medizinische Kompressionsstrümpfe
Bas médicaux de compression
Ta slovenski standard je istoveten z: ENV 12718:2001
ICS:
11.120.20 Sanitetni materiali, obveze in Wound dressings and
komprese compresses
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN PRESTANDARD
ENV 12718
PRÉNORME EUROPÉENNE
EUROPÄISCHE VORNORM
August 2001
ICS 11.120.20
English version
Medical compression hosiery
Bas médicaux de compression Medizinische Kompressionsstrümpfe
This European Prestandard (ENV) was approved by CEN on 23 June 2001 as a prospective standard for provisional application.
The period of validity of this ENV is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the ENV can be converted into a European Standard.
CEN members are required to announce the existence of this ENV in the same way as for an EN and to make the ENV available promptly
at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the ENV) until the final
decision about the possible conversion of the ENV into an EN is reached.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2001 CEN All rights of exploitation in any form and by any means reserved Ref. No. ENV 12718:2001 E
worldwide for CEN national Members.

Contents
page
Foreword .3
Introduction .4
1 Scope.5
2 Normative references.5
3 Terms and definitions.5
4 Compression classes .7
5 Nominal dimensions and standard sizes.7
6 Heel.14
7 Seams.14
8 Edges.15
9 Achievement of compression profile.15
10 Mechanical properties .15
11 Packaging .16
12 Marking and instructions for use .16
Annex A (informative) Hosiery manufacturing methods .18
Annex B Method for testing compressive properties of hosiery.23
(normative)
Annex C (normative) Method of determination of extensibility of hosiery.39
Annex D Examples of methods of compression testing .40
(informative)
Annex ZA (informative) Clauses of this European Prestandard addressing essential
requirements or other provisions of EU Directives.41
Bibliography .43
Foreword
This European Prestandard has been prepared by Technical Committee TC 205 'Non-active medical
devices' the secretariat of which is held by BSI.
This European Prestandard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements of EU
Directive(s).
For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this
prestandard.
Annexes B and C are normative and form part of this European Prestandard. Annexes A, D and ZA are
for information only.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to announce this European Prestandard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg,
Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.
Introduction
An important property of hosiery is its durability, i.e. the retention of its designated compression during
its lifetime. Hitherto the durability of hosiery has been achieved by the choice of the materials of
construction and the methods by which hosiery has been manufactured. Experience has shown that
hosiery having appropriate medical characteristics can be produced by paying due regard to
information in annex A.
1 Scope
This European Prestandard specifies requirements and gives test methods for medical compression
hosiery, including custom-made hosiery (class 030606, EN 29999), knitted from threads made of natural
fibres or synthetic fibres and elastic threads. It is applicable to medical compression hosiery which is
used as a medical device for the treatment of venous and/or lymphatic diseases of the leg. This
European Prestandard does not give requirements connected with the manufacture of hosiery.
NOTE Manufacturing methods that have been shown by experience to be satisfactory are given for information
in annex A.
2 Normative references
This European Prestandard 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 Prestandard only when incorporated in it by amendment or
revision. For undated references the latest edition of the publication referred to applies (including
amendments).
EN 980, Graphical symbols for use in the labelling of medical devices
EN 1041, Information supplied by the manufacturer with medical devices
EN 23758, Textiles — Care labelling code using symbols (ISO 3758:1991)
EN 26330:1993, Textiles — Domestic washing and drying procedures for textile testing
(ISO 6330:1984)
ISO 376, Metallic materials — Calibration of force-proving instruments used for the verification of
uniaxial testing machines
3 Terms and definitions
For the purposes of this Prestandard, the following terms and definitions apply:
3.1
compression
pressure exerted on the leg by the hosiery
3.2
compression classes
compression grades in which hosiery is produced, categorised by the compression at the ankle
3.3
unit of rubber thread thickness
conventional count of a rubber thread
gauge number round (not square)
number of threads which, when placed side by side, measure 25,4 mm
3.4
custom made hosiery
hosiery manufactured individually to suit the leg dimensions of an individual patient
3.5
durability
ability of hosiery to retain its designated compression after a procedure that simulates repeated
washing and wearing
3.6
elastic material
material which increases its dimension under the action of an applied force and returns to almost its
original form when the force is removed
3.7
extensibility
maximum degree, expressed as a percentage of the unloaded size of the hosiery, in which the hosiery
can be stretched in the circumferential or in the longitudinal direction under the test procedure specified
in this European Prestandard
3.8
inlaid thread
elastic thread which does not form stitches or loops and which is inlaid in the direction of the course
3.9
medical compression hosiery
hosiery for treating leg diseases by means of graduated compression exerting a definite pressure on the
leg in a specific way
NOTE Abbreviated in this Prestandard to 'hosiery'.
3.10
practical elongation
elongation of hosiery in the circumferential direction with the hosiery on the leg, expressed as a
percentage of the unloaded circumference of the hosiery
3.11
pressure profile
representation of the compression exerted by the hosiery along the leg
3.12
residual pressure
compression at a certain point expressed as a percentage of the compression at the ankle
3.13
stiffness
increase in compression per centimetre increase in the circumference of the leg, expressed in
hectopascals per centimetre and/or millimetres of mercury per centimetre
3.14
standard size hosiery
hosiery manufactured in the types and sizes specified in this European Prestandard
3.15
tolerance of standard size hosiery
limits of the girth and length of the leg between which the standard size hosiery is intended to be used
3.16
unit of linear density
mass in grams of 10 000 m of yarn expressed in dtex
NOTE The basic unit is the tex (10 dtex = 1g/km)
4 Compression classes
Hosiery shall be classified into five compression classes as shown in Table 1, and the compression shall
be measured in accordance with annex B.
NOTE 1 The package of hosiery compression Class 1 can be labelled in addition as follows:

15 mmHg (20hPa) to17 mmHg (23hPa): Class I.L (low)

18 mmHg (24hPa) to 21 mmHg (28hPa): Class I.H (high)
NOTE 2 Class A reflects the practice in some European countries but it is currently not supported by sufficient
scientific evidence.
Table 1 — Compression classes
1)
Compression class Compression at the ankle
2)
hPa mmHg
Ccl A light 13 to 19 10 to 14
Ccl I mild 20 to 28 15 to 21
Ccl II moderate 31 to 43 23 to 32
Ccl III strong 45 to 61 34 to 46
Ccl IV very strong 65 and higher 49 and higher
1)
The values indicate the compression exerted by the hosiery at a hypothetical cylindrical ankle.
2)
1 mmHg = 1,333 hPa.
5 Nominal dimensions and standard sizes
5.1 General
Hosiery size shall be designated by the lengths and girths on the human leg at the measuring points
given in Figure 1 and Table 2.
5.2 Measurement of length
If measured, lengths shall be measured and codes allocated in accordance with Table 3.
5.3 Measurement of girth
If measured, girths shall be measured and codes allocated in accordance with Table 4.
5.4 Sizes
NOTE In order to facilitate the use of hosiery and to give a unique basis for the test methods specified in this
European Prestandard, this system of sizes is specified based on the ankle girth (cB).
5.4.1 Length
Except for custom-made hosiery, lengths and range of length shall be chosen from Table 5.
5.4.2 Girth
Except for custom-made hosiery, girths and range of girths shall be chosen from Table 6.
5.5 Designation of type and size of hosiery
Hosiery shall be designated by the type code according to Table 7 followed, except for custom-made
hosiery, by three pairs of numbers indicating the dimensions of the legs that the hosiery is intended to fit
as follows:

the range of girth at the ankle according to Table 6

the range of girth at the upper end of the hosiery according to Table 6


the range of length according to Table 5
Where values for intermediate measuring points fall in the same vertical column of Table 6 or on the
straight lines drawn from the smallest and widest ankle dimension to the smallest and widest girth
dimension at the upper end of the hosiery, no further information is required.
If values of intermediate measuring points don’t fall on the straight lines, then a diagrammatic
representation of the range of leg sizes that the hosiery is intended to fit shall be supplied either on the
package, or in a leaflet in the package. The same applies in the figurative sense to the dimensions of the
length given in Table 5.
NOTE 1 An example of type and size designation is AD 22-24 (34-36/41-45)
where
AD is the code for below-knee hosiery;
22-24 is the range of girth at the ankle (22 cm to 24 cm);
34-36 is the range of girth at the upper end of the hosiery (34 cm to 36 cm);
41-45 is the range of length (lD) (41 cm to 45 cm).
For the measuring points between the ankle and the upper end of the hosiery according to Figure 1 the
range of girths shall be marked according to clause 12.
NOTE 2 A further example of type and size designation is AF 22-24 (46-56/60-64)
where
AF is the code for mid-thigh hosiery;
22-24 is the range of girth at the ankle (22 cm to 24 cm);
46-56 is the range of girth at the upper end of the hosiery (46 cm to 56 cm);
60-64 is the range of length (ID) (60 cm to 64 cm)
NOTE Measurements should preferably be taken at the patient's leg in a standing position.
Figure 1 — Measuring points, lengths and girths on the human leg (see Table 2)
Table 2 — Nominal measuring points (see Figure 1)
Description of the measuring point
M
...