ENV 12719:2001
(Main)Medical thrombosis prophylaxis hosiery
Medical thrombosis prophylaxis hosiery
This European Prestandard applies to medical thrombosis prophylaxis hosiery, knitted from threads made of natural fibres or synthetic fibres and elastic threads, which is used as a medical device for prophylaxis of venous thrombosis. The prestandard specifies requirements and test methods, except for custom-made hosiery.
Medizinische prophylaktische Antithrombosestrümpfe
Diese Europäische Vornorm gilt für medizinische Thromboseprophylaxe-Strümpfe, die aus Fäden, hergestellt aus Natur- oder Synthetikfasern und elastischen Fäden, gestrickt werden und als Medizinprodukt für die Prophylaxe von Venenthrombose dienen. Diese Vornorm legt Anforderungen an die Gebrauchseigenschaften sowie Prüfverfahren fest. Diese gelten nicht für Maßstrümpfe.
Bas médicaux prophylaxiques anti-thromboses
Domaine d'application
La présente Prénorme européenne s'applique aux bas médicaux prophylaxiques anti-thromboses tricotés à partir de fils de fibres naturelles ou synthétiques et de fils élastiques, utilisés comme des dispositifs médicaux en prophylaxie des thromboses veineuses. La présente Prénorme prescrit les exigences et méthodes d'essai, qui ne s'appliquent cependant pas aux bas sur mesure.
Medicinske nogavice za preprečevanje tromboze
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST ENV 12719:2002
01-maj-2002
0HGLFLQVNHQRJDYLFH]DSUHSUHþHYDQMHWURPER]H
Medical thrombosis prophylaxis hosiery
Medizinische prophylaktische Antithrombosestrümpfe
Bas médicaux prophylaxiques anti-thromboses
Ta slovenski standard je istoveten z: ENV 12719:2001
ICS:
11.120.20 Sanitetni materiali, obveze in Wound dressings and
komprese compresses
SIST ENV 12719:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST ENV 12719:2002
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SIST ENV 12719:2002
EUROPEAN PRESTANDARD
ENV 12719
PRÉNORME EUROPÉENNE
EUROPÄISCHE VORNORM
August 2001
ICS 11.120.20
English version
Medical thrombosis prophylaxis hosiery
Bas médicaux prophylaxiques anti-thromboses Medizinische prophylaxische Antithrombosestrümpfe
This European Prestandard (ENV) was approved by CEN on 18 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 12719:2001 E
worldwide for CEN national Members.
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ENV 12719:2001 (E)
Contents
page
Foreword .3
Introduction .4
1 Scope.5
2 Normative references.5
3 Definitions.5
4 Compression .6
5 Nominal dimensions and standard sizes.6
6 Heel.13
7 Inspection facility.13
8 Seams.13
9 Edges.13
10 Achievement of compression profile.13
11 Mechanical properties .13
12 Packaging .14
13 Marking and instructions for use .14
Annex A (normative) Method for testing the durability .16
Annex B (normative) Method for testing compressive properties of hosiery.17
Annex C (normative) Method of determination of extensibility of hosiery.33
Annex D (informative) Examples of methods of compression testing .34
Annex ZA (informative) Clauses of this European Prestandard addressing essential
requirements or other provisions of EU Directives.35
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ENV 12719:2001 (E)
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 A, B and C are normative and form part of this European Prestandard. Annexes 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.
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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.
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ENV 12719:2001 (E)
1 Scope
This European Prestandard applies to medical thrombosis prophylaxis hosiery, knitted from threads
made of natural fibres or synthetic fibres and elastic threads, which is used as a medical device for
prophylaxis of venous thrombosis. The prestandard specifies requirements and test methods, except
for custom-made hosiery.
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 20139:1992, Textiles — Standard atmospheres for conditioning and testing (ISO 139:1973).
EN 26330:1993, Textiles — Domestic washing and drying procedures for textile testing
(ISO 6330:1984).
EN 60456:1999, Clothes washing machines for household use — Methods for measuring the
performance (IEC 60456:1998, modified.)
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
durability
ability of the hosiery to retain its designated compression properties
3.3
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
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3.4
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
3.5
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
3.6
pressure profile
representation of the compression exerted by the hosiery along the leg
3.7
residual pressure
compression at a certain point expressed as a percentage of the compression at the ankle
3.8
standard size hosiery
hosiery manufactured in the types and sizes specified in this European Prestandard
3.9
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
3.10
medical thrombosis prophylaxis hosiery
hosiery which when worn on the leg exerts graduated compression on the leg surface and is
principally intended to reduce the incidence of venous thrombosis in non-ambulant patients
NOTE Abbreviated in this prestandard to 'hosiery'.
4 Compression
The compression of the hosiery at the ankle shall be between 13 mmHg and 18 mmHg (respectively
17,5 hPa and 24 hPa). The compression at the ankle shall have a tolerance not exceeding ± 3 mmHg
(4,0 hPa). The compression shall be measured in accordance with annex B.
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 Table 1 and Figure 1.
5.2 Measurement of length
If measured, length shall be measured and codes allocated in accordance with Table 2.
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5.3 Measurement of girth
If measured, girths shall be measured and codes allocated in accordance with Table 3.
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 based on the ankle girth (cB).
5.4.1 Length
Length and range of lengths shall be chosen from Table 4.
5.4.2 Girth
Girths and range of girths shall be chosen from Table 5.
5.5 Designation of type and size of hosiery
5.5.1 Hosiery shall be designated by the type code according to Table 6 followed 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 5;
the range of girth at the upper end of the hosiery according to Table 5;
the range of length according to Table 4.
Where values for intermediate measuring points fall in the same vertical column of Table 5 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 that package. The same applies in the figurative sense to the
dimensions of the length given in Table 4.
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 13.
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NOTE 2 A further example of type and size designation is AG 22-24 (52-64/70-75)
where
AG is the code for thigh hosiery;
22-24 is the range of girth at the ankle (22 cm to 24 cm);
52-64 is the range of girth at the upper end of the hosiery (52 cm to 64 cm)
70-75 is the range of length (IG) (70 cm to 75 cm)
5.5.2 Alternatively a type code specified by the manufacturer shall be available on the hosiery. For
this type code the range of dimensions of the leg that the hosiery is intended to fit shall be indicated
on the package or leaflet, at least for the measurement points B,C and the upper end (D or G) and the
length.
5.5.3 Hosiery intended for multi-patient use shall be optically size and type coded. The coding shall
be wash-resistant (see annex A). The optical size and type code shall be easily identified.
NOTE The coding should be explained in or on the package (see 13.2).
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NOTE Measurements should be preferably taken at the leg of the recumbent patient.
Figure 1 — Measuring points, lengths and girths on the human leg (see Table 1)
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Table 1 — Nominal measuring points
Measuring Description of the measuring point
point
a sole of the foot at the heel
B ankle at the point of its minimum girth
B1 point at which the Achilles tendon changes into the calf muscles
C calf at its maximum girth
D just below the tibial tuberosity
E centre of the patella and over the back of the knee
F between K and E
G 5 cm below K with the patient in the upright position
Table 2 — Nominal measurement of length
Length Length of the leg
code
lB distance measured from a to B
lBl distance measured from a to Bl
lC distance measured from a to C
lD distance measured from a to D
lE distance measured from a to E
lF distance measured from a to F
lG distance measured from a to G
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Table 3 — Nominal measurement of girth
a
Girth code Girth of the leg
cB girth measured at B
cB1 girth measured at B1
cC girth measured at C
cD girth measured at D
cE girth measured at E
cF girth measured at F
cG girth measured at G
a
c = girth.
Table 4 — Nominal leg lengths for standard size hosiery
Length
cm
Length code
short hosiery normal hosiery long hosiery
lG 65 68 71 74 77 80 83
lF 54 57 59 62 64 67 69
lE 41 43 45 47 49 51 53
lD 35 37 38 40 41 43 44
lC 27 29 30 32 33 35 36
lB1 1920 2122 23 24 25
lB 10 11 11 12 12 13 13
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ENV 12719:2001 (E)
Table 5 — Nominal leg girths
Size of hosiery
Girth Slender supplement 18 19 20 21 22 23 24 25 26 27 28 29 30 Sturdy supplement
code
Circumferences in cm
cG 43 45 46 48 49 51 52 54 55 57 58 60 61 63 64 66 67 69 70 72 73 74 76 77 79 80
cF 35 37 38 40 41 43 44 46 47 49 50 52 53 55 56 58 59 60 61 62 63 65 66 68 69 71
cE 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 ---
cD 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 49 --- ---
cC 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 --- --- ---
cB 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 --- --- --- ---
1
cB --- --- 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 --- --- --- ---
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Table 6 — Designation of types of hosiery
Type of hosiery Code
Below-knee hosiery AD
Thigh hosiery AG
6 Heel
Hosiery shall have a closed and knitted heel with the appropriate anatomic form. Testing shall be
carried out by visual inspection.
7 Inspection facility
The hosiery should be designed so that the patient's local circulation can be easily checked.
8 Seams
Seams shall be smooth on the inside of the hosiery.
NOTE Seams can be overlocked.
Testing shall be carried out by visual inspection.
9 Edges
Edges shall be non-fray.
Testing shall be carried out by visual inspection.
10 Achievement of compression profile
The compression profile shall be achieved by knitting and not by shaping or forming.
NOTE There can be boarding for presentation.
11 Mechanical properties
11.1 Extensibility
Hosiery shall be capable of being stretched at least 120 % in the circumferential direction at the
measuring points B, B1, C, D, E and G where appropriate. The stretch capability in the longitudinal
direction shall be at least 30 % at the measuring points B, B1, C, D, E and G, where appropriate.
Testing shall be carried out in accordance with annex C.
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11.2 Practical elongation
The practical elongation shall be not less than 15 % at the measuring points B, B1, C, D, E and G.
Testing shall be carried out in accordance with annex B.
11.3 Residual pressure
In order to avoid irregularities of the pressure profile along the leg, the residual pressure shall be
measured at measuring points B, B1, C, D, E and G, where applicable.
The residual pressure of the hosiery at measuring points C and G, where applicable, shall lie within
the range given in Table 7.
The residual pressure shall at no measuring point along the leg, except E, be of a higher value than
the residual pressure at the measuring point situated distally.
NOTE The residual pressure can be lower at the E-level, than that which follows from the interpolation of the
values D and G.
The pressure profile along the leg shall conform to the values given in Table 7.
Testing shall be carried out in accordance with annex B.
Table 7 — Ranges of pressure profiles
% of compression exerted at ankle
at B1 at C at G
80 to 100 60 to 80 30 to 70
11.4 Durability of compression
Hosiery shall maintain its specified properties after washing. The testing shall be in accordance with
annex A.
12 Packaging
Hosiery shall be packaged so that exposure of the hosiery to light is minimized.
13 Marking and instructions for use
The information supplied by the manufacturer shall comply with EN 980 and EN 1041.
Specification for ranges of length and girth, which differ, according to 5.5, from Table 4 and 5, shall be
made available for the supplier/distributor in a suitable form.
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13.1 Marking of hosiery
Hosiery shall be durably marked at least with the following information:
a) name or trade name of the manufacturer or authorized representative or importer within EEA;
b) name of the product;
c) fibre content (unless marked on the package);
d) type and size designation as specified in 5.5.1 and/or 5.5.2.
13.2 Marking of the package
The package shall be marked at least with the following information:
a) name and address of the manufacturer or authorized representative or importer within EEA;
b) name of the product;
c) country of origin if manufactured outside the European Economic Community;
d) fibre content (unless marked on the hosiery);
e) compression according to clause 4;
f) type and size designation as specified in 5.5.1 and/or 5.5.2.
NOTE A diagrammatic representation of the range of leg sizes that the hosiery is intended to fit can also be
given.
13.3 Instructions for usage and handling
The package or a leaflet with the hosiery shall contain at least the following information:
a) instructions for washing and drying;
b) instructions for use and warnings about misuse (e.g. pulling too hard, folding the upper part
onward
...
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