Use of a PVC-free multilayered tube with improved peelsecurity for medical purpose

0001The invention relates to a PVC-free multilayer hose for medical purposes with improved security of peelability according to the preamble of claim 1, a kink-free hose curl comprising the multilayer hose, a method for producing such PVC-free multilayer hoses according to claim 17 and the use of the PVC according to the invention free multilayer hoses.

0002The state of the art WO-A-92/11820 (= D1), EP-A-0765740 (= D2), US-A-5,466,322 (= D3), US-A-5,804,151 (= D4) and US-A-5,958,167 (= D5).

0003PVC-free materials (non-PVC materials) and single-layer hoses made from them with only one layer are known, for example, from D1. Herein a tube material for medical purposes is presented, which has a blend of polyurethane polyester and which can be subjected to a sterilization treatment in an autoclave, heat-sealable as well as sealable and fusible with high-frequency energy.

0004D2 discloses a PVC-free multilayer tube for medical purposes with at least two layers, of which a base layer A) made of a first plastic material is connected to at least one connection layer B) made of a second plastic material, the first plastic material having at least one polymer that is heat sterilized survives at ≥ 121 ° C without damage to shape, has a Shore D ≤ 32 hardness, which has a residual stress at ≥ 121 ° C that is sufficient to form a press fit at a connection point and from which a curl or a loop with a diameter of up to 60 mm can be formed without kink damage, while the second plastic material comprises at least one polymer which during a heat sterilization at 121 ° C below the the resulting connection pressure tends to flow when a press fit is formed and has a Shore A) ≤ 65 hardness, so that the dimensional stability of the plastic material at temperatures ≥ 121 ° C is given and that of the second plastic material no longer. Although the multilayer hose according to D2 succeeds in providing a flexible hose which is transparent after heat sterilization, has sufficient kink resistance and can be sealed with hose clamps or the like and which also has the ability, with an installation part, to provide one medical bag or a connector to establish a tight and tight connection, extremely simple during a possible heat sterilization treatment, the hose of the D2 is still in need of improvement in one respect.

0005Medical tubing is often delivered in squiggles. In this way, hoses can be transported in a space-saving manner and without the risk of confusion. Hoses can be held together in loops by threads, wires or clamps. However, it is particularly advantageous if the tubes are welded to one another so peelable on their outer layer that they form curls. In this embodiment, the curl can be easily pulled apart without a holding means having to be loosened beforehand and accumulating as waste. This also makes handling easier. The production of such peelable welded curls is part of the prior art (cf. documents D3 - D5).

0006When pulling apart the curl of a hose in accordance with D2, it can now happen that the hose not only detaches from one another at the peelable welding point, but that there is a crack in the outer layer which can propagate into the inner layer. In the worst case, the hose could be damaged so that a leak may occur. Especially at low temperatures and careless opening of the curl, damage can occur which could make the hose unusable.

0007In view of the disadvantages with which the embodiments described in the state of the art are afflicted, it is the object of the invention to provide a hose for medical purposes which has an improved safety of peelability. The novel hose should be easy to assemble to form curls and the curls welded to one another should be easily and safely detachable from one another, in particular without impairing their function. At the same time, the new hose should allow individual adaptation to many different connector or bag materials, in particular those based on polypropylene or polycarbonate. Furthermore, it would be desirable for the new hose material to enable a firm bond without additional adhesion promoter or the like. In addition, the new multi-layer hose should also be sufficiently flexible, elastic and soft and still be as prone to kinking as possible, relatively rigid and thermally stable. After all, the hose should not release any dangerous substances into these fluids when it comes into contact with the fluids common in medicine, and should be inert to medical solutions at all. The aim of the invention is also to provide a method for producing such a multi-layer hose. Furthermore, the specification of possible uses of the hose material according to the invention is the object of the invention.

0008These and other tasks not mentioned in more detail are achieved by a PVC-free multi-layer hose for medical purposes of the type mentioned at the outset with the features of the characterizing part of claim 1. Special developments are protected in the claims dependent on claim 1. In procedural terms, the object according to the invention is achieved by a method according to claim 17, while claims 19-21 protect the use of the PVC-free multilayer hose according to the invention.

0009<u>Because a PVC-free multi-layer hose</u> for medical purposes with improved security of peelability, the multilayer tube comprising at least three layers, of which a base layer A) made of a first plastic material is connected to at least one connection layer B) made of a second plastic material by means of at least one buffer layer C) made of a third plastic material arranged between A) and B) and wherein a curl or loop is made from the multilayer hose can shape with a diameter of up to 50 mm without kink damage, <u>both the first and the second plastic material</u> each 25% by weight or more than 25% by weight based on the weight of the respective layer A) or B) made of polyolefins <u>exist while the third plastic material</u> a proportion of thermoplastic elastomer, which is not polyolefin, of more than 75% by weight, based on the total weight of layer C) <u>surprisingly succeeds</u> to improve the security of the peelability of a hose coil from the multi-layer hose.

0010The present invention is therefore based, inter alia, on the idea of ​​inserting a further buffer layer as a middle layer between the base or inner layer of a multi-layer hose and the connection or outer layer. Due to the relatively higher proportion of elastomer in the buffer layer, it is much softer and mechanically weaker than the base and connection layer (s). There is therefore less adhesion between the buffer layer and the inner or outer layer. When opening the curl, this can lead to the outer layer tearing instead of peeling at the welding point. However, the crack regularly only leads to the buffer layer and never continues into the inner layer. Either the outer layer or the buffer and outer layers are delaminated. Because the shaping inner layer is not damaged, the problem of unusable hoses no longer occurs, even at lower temperatures.

0011Furthermore, according to the invention, the various plastic layers in the multilayer hose material according to the invention are preferably matched to one another such that at least one layer functioning as a base or inner layer gives the hose material sufficient thermal stability during sterilization, while at least one other layer acts as a connection or outer layer, the formation of a firm and tight connection with a bag, connecting piece, Connector or other hose can be used without the need to use additional adhesive, sealing or sealing compounds or aids or other sealing methods (high-frequency energy or the like).

0012The term peelability or the improved safety of peelability plays a special role in the context of the invention for the quality of the multilayer hoses according to the invention. For the invention, "peelability" or "peelability" is to be understood as a property which describes the detachability of curls of a multilayer hose which have been peripherally welded to one another at welding temperatures of 400 ° C. or more and which have been sterilized after the curling formation, under the action of a defined load . This load is applied with a drop weight. Here a test hammer with a weight of 5 kg is attached to the outermost peripherally welded ring. After a free fall of 33 cm, the welded curl is loaded abruptly. The curls are forcibly opened under the influence of the load. If the adjacent squiggles are separated from one another without loss of function of the hose, the hose is peelable.

0013In the multilayer hose according to the invention, the buffer layer C) is substantially "more elastic" or "softer" than the base layer A) and the connection layer B). This is caused by the relatively high elastomer content of greater than 75% by weight, preferably greater than or equal to 80% by weight in layer C). The proportion of thermoplastic elastomer in layer C) is particularly expedient equal to or greater than 90% by weight, particularly preferably the buffer layer C) consists of 100% by weight of thermoplastic elastomer, the quantities given in each case relating to the total weight of layer C ) Respectively. The thermoplastic elastomers which can be used for layer C) are polymeric materials which are not polyolefins.

0014Polyolefins in the sense used in the present description are polymers of alkenes in the broadest sense. These include polyalkanes. Examples include in particular polymethylene, polyethylenes such as PE-LD, PE-HD, PE-LLD, mPE-LLD, modified polyethylenes such as PE-X, VPE or XLPE, polypropylenes, poly-1-butene and higher poly (alpha-olefin) e . These can be homopolymers, copolymers, both as block and statistical copolymers, and terpolymers. The polymers and copolymers of propylene are of particular importance. These in turn include, among others, poly (propylene) which has been polymerized by transition metal catalysts, metallocene polypropylene, atactic and syndiotactic polypropylene and particularly preferably copolymers with ethylene. Here again, those copolymers are preferred which have a low ethylene content, for example of 5% ethylene or less.

0015In contrast to the buffer layer C), in which the polyolefin content is limited to less than 25% by weight, both the first and the second plastic material each have 25% by weight or more than 25% by weight, particularly advantageously more than 30% by weight based on the total weight of the respective layers A) or B) polyolefins. As a result, both the base layer and the connection layer become less elastic than the buffer layer, but mechanically stronger or more stable than the buffer layer.

0016Differences can also be found between the first and second plastic material with regard to the hardness or softness of the materials. Thus, it is preferred for the multilayer hose of the invention that the first plastic material of the base layer is a relatively hard material. In a special embodiment, the first plastic material has a Shore D hardness of less than or equal to 35. Particularly preferably of less than or equal to 32. The second plastic material for the connection layer is expediently a somewhat softer plastic material compared to the plastic material of the first layer. Of particular interest for the invention are those plastic materials which have a Shore D hardness of less than or equal to 60 for the second plastic material . Materials with a Shore D of less than or equal to 55 are expedient, particularly preferably less than or equal to 50. In any case, Shore D> 32 is preferred. Shore D of the second plastic material> 35 is particularly preferred.

0017In the context of the invention, it is also particularly preferred that the third plastic material has a Shore A hardness value that is smaller than the Shore A hardness value of the second plastic material. Plastic materials for the buffer layer with a Shore A hardness value of &lt;60, in particular &lt;55, very particularly preferably &lt;50 are particularly advantageous.

0018There are also differences with regard to the melting temperature or the glass transition temperature of the different plastic materials, such as are used in the different layers of the multilayer hose according to the invention.

0019Furthermore, in the context of the invention, a method for killing or Inactivation (viruses) of all microorganisms including the highly resistant permanent forms understood, the multilayer hoses according to the invention in particular withstanding steam sterilization in an autoclave with pressurized water vapor of at least 121 ° C., corresponding to an atmosphere of excess pressure, the so-called autoclaving or autoclaving treatment, without being damaged.

0020In addition, for the invention, "plastic material" is understood to mean those materials whose essential constituents consist of macromolecular organic compounds, the plastic materials also being referred to as polymers, in particular homopolymers and copolymers (statistical copolymers, block and / or graft polymers) and mixtures (= Blends) from the aforementioned substances.

0021A criterion for the selection and assignment of a polymer according to the invention to a plastic material and thus to a specific functional layer of the multilayer PVC-free tube for medical purposes can also be the dimensional stability during heat sterilization.

0022In this sense, a plastic material is considered to be dimensionally stable if a hose sample with a length of at least 10 mm, an inner diameter of 5 mm and an outer diameter of 7 mm undergoes steam sterilization at 121 ° C for at least 15 minutes. Warm-up time, at least 15 minutes. Holding time and at least 10 min. Cooling time "collapses" or "ovality" etc. survives without a visually visible change in shape.

0023The temperatures given relate to the pressure during steam sterilization, i.e. approx. One atmosphere overpressure. However, it goes without saying that the pressure dependence of the softening temperature in the region under consideration between normal pressure and the excess pressure required for steam sterilization is generally negligible.

0024Depending on the desired function of the PVC-free multilayer hose according to the invention, it may be advantageous to arrange a layer B) which is especially capable of forming a connection only on the outside or both outside and inside. Another buffer layer inside (between an inner connection layer B) and the base layer A)) is optional.

0025In a particularly expedient embodiment, the multilayer hose according to the invention is characterized by a sequence of layers A) C) B) or B) A) C) B), each from the inside to the outside. In any case, a hose curl can be released from the multilayer hose according to the invention without problems. In the first case, the hose according to the invention is intended for insertion into a hollow part, the inner surface of which consists of a suitable material for forming a connection, while if two connection layers (outside and inside) are arranged in the PVC-free multilayer hose according to the invention, the two connection options mentioned can be implemented either selectively or simultaneously .

0026In the case of PVC-free multilayer hoses which are particularly expedient according to the invention and have improved peelability, the first plastic material for the inner layer is predominantly a synthetic rubber based on isoprene or polypropylene with a density of 0.9 g / cm³ and the second plastic material for the outer layer for practice predominantly a polypropylene copolymer with a low ethylene content of about 4%. The buffer layer in between is preferably a SEBS or a mixture of SEBS polymers with a styrene content of 13 to 30%. This combination for each base layer A), outer layer B) and buffer layer C) can already fulfill a large number of required properties. A polymer use according to the following list is particularly advantageous for the invention. Percentages mean weight percent.<tables id="tabl0001" num="0001"><table frame="all"><tgroup cols="2" colsep="1" rowsep="0"><colspec colnum="1" colname="col1" colwidth="78.75mm" /><colspec colnum="2" colname="col2" colwidth="78.75mm" /><tbody valign="top"><row><entry namest="col1" nameend="col1" align="left"><u>Inner layer:</u></entry><entry namest="col2" nameend="col2" align="left">Thickness: 900 - 980 µm at approx. 1 mm wall thickness of the hose</entry></row><row><entry namest="col1" nameend="col1" /></row><row><entry namest="col1" nameend="col1" align="left">50-75% SIS blend</entry><entry namest="col2" nameend="col2" align="left">(HVS / 3, Kuraray or Hybrar 7125F, Kuraray)</entry></row><row><entry namest="col1" nameend="col1" align="left">and 50-25% PP-R</entry><entry namest="col2" nameend="col2" align="left">(PP 23M10cs264, REXENE); - PP with Shore D ≤ 32, ρ = 0.9 g / cm³; (e.g. Adflex 100 G, Himont, with up to 50% rubber, eg PIB, styrene-ethylene-butylene rubber, styrene-ethylene-propylene rubber, SIS or (RD204CF, Borealis A / S); - PP copolymer</entry></row><row><entry namest="col1" nameend="col1" /></row><row><entry namest="col1" nameend="col1" align="left"><u>Outer layer:</u></entry><entry namest="col2" nameend="col2" align="left">Thickness 15-100 µm</entry></row><row><entry namest="col1" nameend="col1" align="left">Blend out</entry><entry namest="col2" nameend="col2" /></row><row><entry namest="col1" nameend="col1" align="left">50 - 75% PP-R</entry><entry namest="col2" nameend="col2" align="left">(PP 23M10cs264, REXENE or</entry></row><row><entry namest="col1" nameend="col1" /><entry namest="col2" nameend="col2" align="left">RD 204 CF, Borealis A / S) and</entry></row><row><entry namest="col1" nameend="col1" align="left">25th - 50% SIS</entry><entry namest="col2" nameend="col2" align="left">(HVS / 3, Kuraray or Hybrar 7125 F, Kuraray);</entry></row><row><entry namest="col1" nameend="col1" /></row><row><entry namest="col1" nameend="col1" align="left"><u>Buffer layer:</u></entry><entry namest="col2" nameend="col2" align="left">Thickness 10 - 50 µm</entry></row><row><entry namest="col1" nameend="col1" /></row><row><entry namest="col1" nameend="col1" align="left">100 % SEBS</entry><entry namest="col2" nameend="col2" align="left">(Kraton 1657, Shell)</entry></row><row><entry namest="col1" nameend="col1" /><entry namest="col2" nameend="col2" align="left">SEBS with 13% styrene or</entry></row><row><entry namest="col1" nameend="col1" /><entry namest="col2" nameend="col2" align="left">(Tuftec H 1052, Asahi)</entry></row><row><entry namest="col1" nameend="col1" /><entry namest="col2" nameend="col2" align="left">SEBS with 20% styrene or</entry></row><row><entry namest="col1" nameend="col1" /><entry namest="col2" nameend="col2" align="left">(Tuftec H 1062, Asahi)</entry></row><row><entry namest="col1" nameend="col1" /><entry namest="col2" nameend="col2" align="left">SEBS with 18% styrene</entry></row><row><entry namest="col1" nameend="col1" align="left">or</entry><entry namest="col2" nameend="col2" /></row><row><entry namest="col1" nameend="col1" align="left">100 % SBS</entry><entry namest="col2" nameend="col2" align="left">(Styroflex BX 6105, BASF)</entry></row><row><entry namest="col1" nameend="col1" /><entry namest="col2" nameend="col2" align="left">SBS with 70% styrene</entry></row><row><entry namest="col1" nameend="col1" align="left">or</entry><entry namest="col2" nameend="col2" /></row><row><entry namest="col1" nameend="col1" align="left">Blend out</entry><entry namest="col2" nameend="col2" /></row><row><entry namest="col1" nameend="col1" align="left">50 - 90% SEBS</entry><entry namest="col2" nameend="col2" align="left">(e.g. Kraton G 1726, Shell) and</entry></row><row><entry namest="col1" nameend="col1" align="left">10th - 50% SEBS</entry><entry namest="col2" nameend="col2" align="left">(e.g. Kraton 1625M, Shell)</entry></row><row rowsep="1"><entry namest="col1" nameend="col1" /><entry namest="col2" nameend="col2" align="left">SEBS with 29% styrene;</entry></row></tbody></tgroup></table></tables>

0027The abbreviations mean in detail:<dl id="dl0001" compact="compact"><dt>PP-R =</dt><dd>Polypropylene random copolymer</dd><dt>SIS =</dt><dd>Styrene-isoprene-styrene</dd><dt>SEBS =</dt><dd>Styrene-ethylene-butylene-styrene rubber</dd><dt>SBS =</dt><dd>Styrene-butylene-styrene rubber</dd></dl>

0028Again, with regard to the adhesion between layers made of materials A), B) and C), it can be said that this is basically sufficient. However, it can be increased in an advantageous manner by the layers A), B) and / or C) in each case additionally up to 40% by weight, based on 100% by weight of their composition as described and defined above, of that plastic material have, which serves to form one or both adjacent layers of the PVC-free multilayer hose.

0029This "material mediation" or the substitution of material significantly increases the compatibility of the layers formed into a tube without questioning the other properties.

0030Another essential and particularly preferred feature of the invention is that in a further development of the PVC-free multilayer hose according to the invention, the plastic materials for all layers of the hose are selected such that they essentially consist of polyolefin homopolymers or polyolefin copolymers and modifications thereof (e.g. SEBS) . It was particularly astonishing that the invention succeeded in creating a PVC-free multi-layer hose which consists exclusively of environmentally compatible materials, which allow problem-free connection formation with connectors during steam sterilization and at the same time meet all other requirements for a hose which can be used medically, in particular thus have improved peelability.

0031With regard to the geometry, the hoses themselves can be designed in all required and customary thicknesses and sizes. The PVC-free multilayer hose according to the invention preferably consists of more than 96-98% by volume, based on the total volume of the hose material, of the base layer A). In a particularly expedient embodiment, the multilayer hose according to the invention is characterized in that the base layer A) has a thickness in the range from 800 to 1000 μm. Of particular interest are base layers A) which have a thickness of> 900 μm, preferably of approximately 910–930 μm, particularly preferably of 920–980 μm. Also of particular interest for the invention are embodiments of the multi-layer hose in which the outer layer B) has a thickness in the range from 15 to 100 μm. Outer layers B) or connection layers B) which have a thickness in the range of 20-80 μm, preferably 30-70 μm and particularly preferably of approximately 50 μm are particularly expedient. Multilayer hoses are also of particular interest for the invention, in which the buffer layer C) has a thickness of less than 100 μm. In a particularly advantageous modification of this, the multilayer hose of the present invention is characterized in that the buffer layer C) has a thickness in the range from 10 to 30 μm, and very particularly expediently has a thickness in the range from approximately 20 to 30 μm. In particular, embodiments of the multilayer hose according to the invention in which the thickness of the buffer layer C) is smaller relative to the thickness of the outer layer B) are particularly advantageous. This enables a safe peeling of welded hose coils or parts of the hose without endangering the sensitive inner layer of the hose.

0032Of importance for the invention is the selection of the layer materials to be extruded with one another, plastic materials or layers being particularly preferably selected such that all layers of the PVC-free multilayer hose essentially consist of polyolefin homopolymers and / or polyolefin copolymers, or of polymers based thereon such as modifications of polyoefins (e.g. SEBS, SBS and the like).

0033The coextrusion of such materials is known in principle, but based on existing experience, the successful implementation of a complex multilayer hose such as that according to the invention was not readily predictable. In this respect, the success according to the invention was surprising, since practice has repeatedly shown that even with the aid of properties of polymers that may be tabulated, such as data on bond adhesion, the use of such materials does not necessarily lead to success. This means that the solution to a given task through a pure selection from known materials is fundamentally not readily possible with a multi-layer coextrusion tube. Coordinating the viscosity of the melt is particularly difficult when coextruding rubbers such as SEBS with PP. Furthermore, it is advantageously possible in the method according to the invention that the plastic materials are selected to form a PVC-free multilayer hose so that all layers of the hose can additionally contain up to 40% by weight of the material of the adjacent layer or layers. In this way, a slight adhesion between two adjacent layers can be compensated to a certain extent. After the actual shaping, the tube obtained can be processed further in the usual ways. It is preferably shock-cooled with water after molding. As a result of the "freezing" of the amorphous state, an optimal bond with high flexibility and sufficient rigidity is achieved, but above all, the shock-like cooling of the melt improves the transparency of the tube because no crystalline areas can form. This leads to a low degree of crystallinity and thus to high transparency and toughness. The PVC-free multilayer hose according to the invention is excellently suitable for use in the medical field. The materials of the multi-layer hose are all selected in such a way that the hose is transparent, kink-resistant and flexible, but in particular hot-sterilizable and can be firmly connected to a corresponding connector by a pressure force exerted by the hose. In addition, the non-PVC multilayer hose of the invention is also biocompatible. The use of PVC, which always contains plasticizers, is avoided, and no adhesion promoters are required, which could diffuse through the plastic material layers.

0034Because of its excellent material and usage properties, the PVC-free multilayer hose according to the invention is used with great advantage as a fluid-carrying line in dialysis, infusion or artificial nutrition. For this purpose, it can advantageously be provided that at least the connection area for connection to the storage bag is provided with a welding lip.

0035Here, the compatibility of the connection layer material of the multi-layer hose according to the invention with the connectors of medical bags (especially made of polypropylene) and / or especially in medical technology, for example in the form of connectors made of polypropylene, is used. Connectors or bags can be provided with a rough surface onto which a PVC-free multi-layer hose according to the invention is plugged, so that the inner surface of the PVC-free multi-layer hose with the connection layer B) of the hose press-fits with the rough outer surface of the connector or bag ( if necessary, connecting piece of the bag).

0036Due to the surface of the polypropylene parts and the flow properties of the connection layer B) of the hose when exposed to heat, for example during steam sterilization, an already good and firm connection is given by the material of the connection layer flowing into the unevenness of the surface of the connector or bag socket. The connection becomes even better if the plastic materials used to produce the connection layer B) of the hose have a proportion of between 1 and 40% by weight, based on 100% by weight of the material of the connection layer, with a plastic material from which the connector or the connection piece of the bag is dazzled. The connection can be improved by roughening the surface.

0037Further advantages and details of the invention result from the following examples, which are explained with reference to the attached figures.

0038The figure shows a schematic diagram of a PVC-free multi-layer hose.

0039The representation according to the figure is a basic representation of a multi-layer hose. In particular, part of a longitudinal section of two sections (crimp) of a three-layer hose welded together is shown in the figure, areas of the hose which are not involved in the welding of two layers B) being omitted in the longitudinal section.

0040In the figure, A) denotes the inner layer of a multi-layer hose according to the invention. B) stands for the outer layer of a multilayer hose according to the invention, while C) describes the intermediate or buffer layer which is arranged between the layers A) and B). The figure shows two sections of a multilayer hose according to the invention welded together on the surface of layer B). The reference numeral 1 stands for the weld seam which can be obtained by welding two sections of the outer layer of the multilayer hose according to the invention. Areas can be seen in the basic sketch shown, in which the weld seam between the outer layer B) of the multilayer hose was opened, while in other areas the weld seam is still intact, the two sections or curls of the hose are therefore still welded to one another. By applying a force F, which acts in the manner indicated by the direction of the arrow on the welded rings of the multilayer hose, the two hose rings welded together are released. The inner tube A) remains completely intact, while, for example. shown at reference number 2, in the event of tearing of the outer layer B) at the latest in the area of ​​the buffer layer C), a clean, non-destructive separation between the hose coils results. Thus, the operability of the multi-layer hose according to the invention can be maintained even if the outer layer tears. The hose according to the invention can be peeled safely.

0041In the following, the invention is further explained using exemplary multi-layer hoses, in particular tests on the peelability of the hoses according to the invention are described.

0042Table 1 (below) shows the composition of the layers of multilayer hoses according to the invention. In Table 1, AS means: outer layer, MS: middle layer or here buffer layer and IS: inner layer. All materials specified in the first column of the table, if they are blends, are previously compounded and granulated. They are not dry blends. The MFI of the blends SA131 was 5.9 (as the outer layer), the MFI of the blend SI07 was 15 (as the buffer layer), the MFI of XM130 was 4.6 (as the inner layer). The curls were produced according to the prior art, then welded at the temperatures given in Tables 3 and 4 and sterilized by conventional methods, and then stored for four days under the test temperatures given in Tables 3 and 4. The squiggles were then tested using the test hammer method described at the beginning. The drop weight of the test hammer was 5 kg, the free fall height of the hammer was 33 cm. After the test hammer has fallen free 33 cm, the squiggles are loaded and positively opened. The solubility test of the curls of sterilized hose curls was carried out at different temperatures, namely 23 ° C, 15 ° C and 5 ° C.

0043The results of the tests are shown in the tables below.<tables id="tabl0002" num="0002"><img file="EP1524109A2_D0001.tif" /></tables><tables id="tabl0003" num="0003"><table frame="all"><title>Table 2</title><tgroup cols="6" colsep="1" rowsep="1"><colspec colnum="1" colname="col1" colwidth="26.25mm" /><colspec colnum="2" colname="col2" colwidth="26.25mm" /><colspec colnum="3" colname="col3" colwidth="26.25mm" /><colspec colnum="4" colname="col4" colwidth="26.25mm" /><colspec colnum="5" colname="col5" colwidth="26.25mm" /><colspec colnum="6" colname="col6" colwidth="26.25mm" /><thead valign="top"><row><entry namest="col1" nameend="col6" align="left"><b>1. Manufacturers of materials:</b></entry></row><row><entry namest="col1" nameend="col2" align="center"><b>Trade name</b></entry><entry namest="col3" nameend="col4" align="center"><b>material</b></entry><entry namest="col5" nameend="col6" align="center"><b>Manufacturer</b></entry></row></thead><tbody valign="top"><row><entry namest="col1" nameend="col2" align="center">RD204CF</entry><entry namest="col3" nameend="col4" align="center">PP copolemer</entry><entry namest="col5" nameend="col6" align="center">Borealis A / S</entry></row><row><entry namest="col1" nameend="col2" align="center">Hybrar 7125F</entry><entry namest="col3" nameend="col4" align="center">SIS elastomer</entry><entry namest="col5" nameend="col6" align="center">Kuraray Co., Ltd.</entry></row><row rowsep="0"><entry namest="col1" nameend="col2" align="center">KratonG1726</entry><entry namest="col3" nameend="col4" align="center">SEBS elastomer</entry><entry namest="col5" nameend="col6" morerows="2" rowsep="1" align="center">Shell Chemical Company</entry></row><row rowsep="0"><entry namest="col1" nameend="col2" align="center">Kraton1652M</entry><entry namest="col3" nameend="col4" align="center">SEBS elastomer</entry></row><row><entry namest="col1" nameend="col2" align="center">Kraton1657</entry><entry namest="col3" nameend="col4" align="center">SEBS elastomer</entry></row><row rowsep="0"><entry namest="col1" nameend="col2" align="center">TuftecH1052</entry><entry namest="col3" nameend="col4" align="center">SEBS elastomer</entry><entry namest="col5" nameend="col6" morerows="1" rowsep="1" align="center">Asahi Chemical Industry Co., Ltd. Asahi Chemical Industry Co., Ltd.</entry></row><row><entry namest="col1" nameend="col2" align="center">TuftecH1062</entry><entry namest="col3" nameend="col4" align="center">SEBS elastomer</entry></row></tbody></tgroup><tgroup cols="6" colsep="1" rowsep="1"><colspec colnum="1" colname="col1" colwidth="26.25mm" /><colspec colnum="2" colname="col2" colwidth="26.25mm" /><colspec colnum="3" colname="col3" colwidth="26.25mm" /><colspec colnum="4" colname="col4" colwidth="26.25mm" /><colspec colnum="5" colname="col5" colwidth="26.25mm" /><colspec colnum="6" colname="col6" colwidth="26.25mm" /><thead valign="top"><row><entry namest="col1" nameend="col6" align="left"><b>2nd Some properties of the materials</b></entry></row><row><entry namest="col1" nameend="col1" align="center"><b>Trade name</b></entry><entry namest="col2" nameend="col2" align="center"><b>group</b></entry><entry namest="col3" nameend="col3" align="center"><b>Ethylene or styrene [%]</b></entry><entry namest="col4" nameend="col4" align="center"><b>Tm or Tg [° C]</b></entry><entry namest="col5" nameend="col5" align="center"><b>MFI [g / 10min]</b></entry><entry namest="col6" nameend="col6" align="center"><b>Shore A</b></entry></row></thead><tbody valign="top"><row><entry namest="col1" nameend="col1" align="center">RD204CF</entry><entry namest="col2" nameend="col2" align="center">I.</entry><entry namest="col3" nameend="col3" align="center">4</entry><entry namest="col4" nameend="col4" align="center">151</entry><entry namest="col5" nameend="col5" align="center">8</entry><entry namest="col6" nameend="col6" align="center">much harder!</entry></row><row><entry namest="col1" nameend="col1" align="center">Hybrar7125F</entry><entry namest="col2" nameend="col2" /><entry namest="col3" nameend="col3" align="center">20</entry><entry namest="col4" nameend="col4" align="center">90 u. -15</entry><entry namest="col5" nameend="col5" align="center">4</entry><entry namest="col6" nameend="col6" align="center">64</entry></row><row rowsep="0"><entry namest="col1" nameend="col1" align="center">KratonG1726</entry><entry namest="col2" nameend="col2" /><entry namest="col3" nameend="col3" align="center">30</entry><entry namest="col4" nameend="col4" align="center">90 u. -45</entry><entry namest="col5" nameend="col5" align="center">65</entry><entry namest="col6" nameend="col6" align="center">60</entry></row><row rowsep="0"><entry namest="col1" nameend="col1" align="center">Kraton1652M</entry><entry namest="col2" nameend="col2" align="center">II</entry><entry namest="col3" nameend="col3" align="center">29</entry><entry namest="col4" nameend="col4" align="center">90 u. -45</entry><entry namest="col5" nameend="col5" align="center">10</entry><entry namest="col6" nameend="col6" align="center">75r</entry></row><row><entry namest="col1" nameend="col1" align="center">Kraton1657</entry><entry namest="col2" nameend="col2" /><entry namest="col3" nameend="col3" align="center">13</entry><entry namest="col4" nameend="col4" align="center">90 u. -55</entry><entry namest="col5" nameend="col5" align="center">8</entry><entry namest="col6" nameend="col6" align="center">65</entry></row><row rowsep="0"><entry namest="col1" nameend="col1" align="center">TuftecH1052</entry><entry namest="col2" nameend="col2" /><entry namest="col3" nameend="col3" align="center">20</entry><entry namest="col4" nameend="col4" align="center">90 u. -26</entry><entry namest="col5" nameend="col5" align="center">13</entry><entry namest="col6" nameend="col6" align="center">67</entry></row><row rowsep="1"><entry namest="col1" nameend="col1" align="center">TuftecH1062</entry><entry namest="col2" nameend="col2" /><entry namest="col3" nameend="col3" align="center">18</entry><entry namest="col4" nameend="col4" align="center">90 u. -32</entry><entry namest="col5" nameend="col5" align="center">4,5</entry><entry namest="col6" nameend="col6" align="center">67</entry></row></tbody></tgroup></table></tables><tables id="tabl0004" num="0004"><table frame="all"><title>Table 3</title><tgroup cols="8" colsep="1" rowsep="1"><colspec colnum="1" colname="col1" colwidth="19.68mm" /><colspec colnum="2" colname="col2" colwidth="19.68mm" /><colspec colnum="3" colname="col3" colwidth="19.68mm" /><colspec colnum="4" colname="col4" colwidth="19.68mm" /><colspec colnum="5" colname="col5" colwidth="19.68mm" /><colspec colnum="6" colname="col6" colwidth="19.68mm" /><colspec colnum="7" colname="col7" colwidth="19.68mm" /><colspec colnum="8" colname="col8" colwidth="19.68mm" /><thead valign="top"><row><entry namest="col1" nameend="col1" rowsep="0" align="center"><b>Test temperature</b></entry><entry namest="col2" nameend="col2" rowsep="0" align="center"><b>Type of error</b> Sweat tmp.</entry><entry namest="col3" nameend="col8" align="center"><b>Sterile sample tubes</b>Welding temperature level I</entry></row><row><entry namest="col1" nameend="col1" /><entry namest="col2" nameend="col2" /><entry namest="col3" nameend="col3" align="center">Default* 400 ° C</entry><entry namest="col4" nameend="col4" align="center">V40 410 ° C</entry><entry namest="col5" nameend="col5" align="center">V41 410 ° C</entry><entry namest="col6" nameend="col6" align="center">V42 410 ° C</entry><entry namest="col7" nameend="col7" align="center">V43 410 ° C</entry><entry namest="col8" nameend="col8" align="center">V44 * 430 ° C</entry></row></thead><tbody valign="top"><row><entry namest="col1" nameend="col1" morerows="4" align="center"><b>5 ° C</b>(15 coils each)</entry><entry namest="col2" nameend="col2" align="center">Complete tear (> 10mm, rupture)</entry><entry namest="col3" nameend="col3" align="center">0</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Tear (≥ 1 mm, hole!)</entry><entry namest="col3" nameend="col3" align="center">1 (7%)</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Strong tear (300µ ~ <1mm)</entry><entry namest="col3" nameend="col3" align="center">3 (20%)</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Slight tear (100µ ~ 300µ)</entry><entry namest="col3" nameend="col3" align="center">8 (53%)</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Exfoliate / delaminate</entry><entry namest="col3" nameend="col3" align="center">3 (20%)</entry><entry namest="col4" nameend="col4" align="center">15 (100%)</entry><entry namest="col5" nameend="col5" align="center">15 (100%)</entry><entry namest="col6" nameend="col6" align="center">15 (100%)</entry><entry namest="col7" nameend="col7" align="center">15 (100%)</entry><entry namest="col8" nameend="col8" align="center">15 (100%)</entry></row><row><entry namest="col1" nameend="col1" morerows="4" align="center"><b>16 ° C</b>(15 coils each)</entry><entry namest="col2" nameend="col2" align="center">Complete tear (> 10mm, rupture)</entry><entry namest="col3" nameend="col3" align="center">0</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Rip (≥1mm, hole!)</entry><entry namest="col3" nameend="col3" align="center">2 (13%)</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Strong tear (300µ ~ <1mm)</entry><entry namest="col3" nameend="col3" align="center">3 (20%)</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Slight tear (100µ ~ 300µ)</entry><entry namest="col3" nameend="col3" align="center">3 (20%)</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Exfoliate / delaminate</entry><entry namest="col3" nameend="col3" align="center">7 (47%)</entry><entry namest="col4" nameend="col4" align="center">15 (100%)</entry><entry namest="col5" nameend="col5" align="center">15 (100%)</entry><entry namest="col6" nameend="col6" align="center">15 (100%)</entry><entry namest="col7" nameend="col7" align="center">15 (100%)</entry><entry namest="col8" nameend="col8" align="center">15 (100%)</entry></row><row><entry namest="col1" nameend="col1" morerows="4" align="center"><b>22 ° C</b>(15 coils each)</entry><entry namest="col2" nameend="col2" align="center">Complete tear (> 10mm, rupture)</entry><entry namest="col3" nameend="col3" align="center">0</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Rip (≥1mm, hole!)</entry><entry namest="col3" nameend="col3" align="center">0</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Strong tear (300µ ~ <1mm)</entry><entry namest="col3" nameend="col3" align="center">0</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Slight tear (100µ ~ 300µ)</entry><entry namest="col3" nameend="col3" align="center">9 (60%)</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row rowsep="1"><entry namest="col2" nameend="col2" align="center">Exfoliate / delaminate</entry><entry namest="col3" nameend="col3" align="center">6 (40%)</entry><entry namest="col4" nameend="col4" align="center">15 (100%)</entry><entry namest="col5" nameend="col5" align="center">15 (100%)</entry><entry namest="col6" nameend="col6" align="center">15 (100%)</entry><entry namest="col7" nameend="col7" align="center">15 (100%)</entry><entry namest="col8" nameend="col8" align="center">15 (100%)</entry></row></tbody></tgroup><tgroup cols="8" colsep="0" rowsep="0"><colspec colnum="1" colname="col1" colwidth="19.68mm" /><colspec colnum="2" colname="col2" colwidth="19.68mm" /><colspec colnum="3" colname="col3" colwidth="19.68mm" /><colspec colnum="4" colname="col4" colwidth="19.68mm" /><colspec colnum="5" colname="col5" colwidth="19.68mm" /><colspec colnum="6" colname="col6" colwidth="19.68mm" /><colspec colnum="7" colname="col7" colwidth="19.68mm" /><colspec colnum="8" colname="col8" colwidth="19.68mm" /><tbody valign="top"><row><entry namest="col1" nameend="col8" align="justify">* Standard refers to the hose without a buffer layer</entry></row></tbody></tgroup></table></tables><tables id="tabl0005" num="0005"><table frame="all"><title>Table 4</title><tgroup cols="8" colsep="1" rowsep="1"><colspec colnum="1" colname="col1" colwidth="19.68mm" /><colspec colnum="2" colname="col2" colwidth="19.68mm" /><colspec colnum="3" colname="col3" colwidth="19.68mm" /><colspec colnum="4" colname="col4" colwidth="19.68mm" /><colspec colnum="5" colname="col5" colwidth="19.68mm" /><colspec colnum="6" colname="col6" colwidth="19.68mm" /><colspec colnum="7" colname="col7" colwidth="19.68mm" /><colspec colnum="8" colname="col8" colwidth="19.68mm" /><thead valign="top"><row><entry namest="col1" nameend="col1" rowsep="0" align="center"><b>Test temperature</b></entry><entry namest="col2" nameend="col2" rowsep="0" align="center"><b>Type of error</b>Sweat tmp.</entry><entry namest="col3" nameend="col8" align="center"><b>Sterile sample tubes</b>Welding temperature level II</entry></row><row><entry namest="col1" nameend="col1" /><entry namest="col2" nameend="col2" /><entry namest="col3" nameend="col3" align="center">Default* 430 ° C</entry><entry namest="col4" nameend="col4" align="center">V40 440 ° C</entry><entry namest="col5" nameend="col5" align="center">V41 440 ° C</entry><entry namest="col6" nameend="col6" align="center">V42 440 ° C</entry><entry namest="col7" nameend="col7" align="center">V43 440 ° C</entry><entry namest="col8" nameend="col8" align="center">V44 * 460 ° C</entry></row></thead><tbody valign="top"><row><entry namest="col1" nameend="col1" morerows="4" align="center"><b>5 ° C</b> (15 coils each)</entry><entry namest="col2" nameend="col2" align="center">Complete tear (> 10mm, rupture)</entry><entry namest="col3" nameend="col3" align="center">0</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Rip (≥1mm, hole!)</entry><entry namest="col3" nameend="col3" align="center">1 (7%)</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Strong tear (300µ ~ <1mm)</entry><entry namest="col3" nameend="col3" align="center">7 (47%)</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Slight tear (100µ ~ 300µ)</entry><entry namest="col3" nameend="col3" align="center">5 (33%)</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Exfoliate / delaminate</entry><entry namest="col3" nameend="col3" align="center">2 (13%)</entry><entry namest="col4" nameend="col4" align="center">15 (100%)</entry><entry namest="col5" nameend="col5" align="center">15 (100%)</entry><entry namest="col6" nameend="col6" align="center">15 (100%)</entry><entry namest="col7" nameend="col7" align="center">15 (100%)</entry><entry namest="col8" nameend="col8" align="center">15 (100%)</entry></row><row><entry namest="col1" nameend="col1" morerows="4" align="center"><b>16 ° C</b> (15 coils each)</entry><entry namest="col2" nameend="col2" align="center">Complete tear (> 10mm, rupture)</entry><entry namest="col3" nameend="col3" align="center">0</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Rip (≥1mm, hole!)</entry><entry namest="col3" nameend="col3" align="center">1 (7%)</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Strong tear (300µ ~ <1mm)</entry><entry namest="col3" nameend="col3" align="center">2 (13%)</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Slight tear (100µ ~ 300µ)</entry><entry namest="col3" nameend="col3" align="center">2 (13%)</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Exfoliate / delaminate</entry><entry namest="col3" nameend="col3" align="center">10 (67%)</entry><entry namest="col4" nameend="col4" align="center">15 (100%)</entry><entry namest="col5" nameend="col5" align="center">15 (100%)</entry><entry namest="col6" nameend="col6" align="center">15 (100%)</entry><entry namest="col7" nameend="col7" align="center">15 (100%)</entry><entry namest="col8" nameend="col8" align="center">15 (100%)</entry></row><row><entry namest="col1" nameend="col1" morerows="4" align="center"><b>22 ° C</b> (15 coils each)</entry><entry namest="col2" nameend="col2" align="center">Complete tear (> 10mm, rupture)</entry><entry namest="col3" nameend="col3" align="center">0</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Rip (≥1mm, hole!)</entry><entry namest="col3" nameend="col3" align="center">0</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Strong tear (300µ ~ <1mm)</entry><entry namest="col3" nameend="col3" align="center">6 (40%)</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row><entry namest="col2" nameend="col2" align="center">Slight tear (100µ ~ 300µ)</entry><entry namest="col3" nameend="col3" align="center">3 (20%)</entry><entry namest="col4" nameend="col4" align="center">0</entry><entry namest="col5" nameend="col5" align="center">0</entry><entry namest="col6" nameend="col6" align="center">0</entry><entry namest="col7" nameend="col7" align="center">0</entry><entry namest="col8" nameend="col8" align="center">0</entry></row><row rowsep="1"><entry namest="col2" nameend="col2" align="center">Exfoliate / delaminate</entry><entry namest="col3" nameend="col3" align="center">6 (40%)</entry><entry namest="col4" nameend="col4" align="center">15 (100%)</entry><entry namest="col5" nameend="col5" align="center">15 (100%)</entry><entry namest="col6" nameend="col6" align="center">15 (100%)</entry><entry namest="col7" nameend="col7" align="center">15 (100%)</entry><entry namest="col8" nameend="col8" align="center">15 (100%)</entry></row></tbody></tgroup><tgroup cols="8" colsep="0" rowsep="0"><colspec colnum="1" colname="col1" colwidth="19.68mm" /><colspec colnum="2" colname="col2" colwidth="19.68mm" /><colspec colnum="3" colname="col3" colwidth="19.68mm" /><colspec colnum="4" colname="col4" colwidth="19.68mm" /><colspec colnum="5" colname="col5" colwidth="19.68mm" /><colspec colnum="6" colname="col6" colwidth="19.68mm" /><colspec colnum="7" colname="col7" colwidth="19.68mm" /><colspec colnum="8" colname="col8" colwidth="19.68mm" /><tbody valign="top"><row><entry namest="col1" nameend="col8" align="justify">* Standard = without buffer layer</entry></row></tbody></tgroup></table></tables>