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Tygon® ND 100-65

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TYGON® ND 100-65

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Description

Tygon® ND 100-65 - dialysis, chemotherapy drug delivery and minimally invasive surgeries

The next generation in non-DEHP tubing

Tygon® ND 100-65 tubing, one of the medical industry’s first non-DEHP tubing offerings, has been formulated specifically to meet the demanding challenges of applications such as dialysis, chemotherapy drug delivery and minimally invasive surgeries.

Characteristics

From open heart surgery to dialysis, Tygon® ND 100-65 tubing has been specially formulated for medical device manufacturers that require a non- DEHP plasticized material. ND 100-65 sets the new standard for performance and durability in blood contact applications. The unique chemistry enables Tygon® ND 100-65 to demonstrate very low extractables in both soapy water and refluxed water, which is rare for this type of material. Tygon® ND 100-65 also demonstrates excellent blood interaction characteristics.

Tygon® ND Series was formulated to meet the requirements of Regulation (EC) 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and does not contain any reportable substances or chemicals of concern. To ensure compliance, every individual compound lot is tested to ensure DEHP levels are <1000 ppm. During the extrusion process, individual product dimensions are maintained and monitored through in-line micrometers and off-line verification with computerized imaging equipment.

Consistent with many medical tubing requirements, Tygon® ND-100-65 material can be effectively bonded/welded using the following methods: heat, electronic (RF)/ultrasonic, solvent and adhesive. Factors to be considered when selecting the components include: security of the bond required, effect on the integrity of the materials to be joined and presence of residues or extractables that may affect biocompatibility. When bonding procedures are not used, mechanical clamps are recommended to provide secure attachment.

Biocompatibility

Tygon® ND 100-65 tubing is made from a biocompatible non-DEHP polymer material developed specifically for blood contact medical device needs. Tygon® ND 100-65 has been tested to various elements of ISO 10993 and USP including cytotoxicity, hemocompatibility, genotoxicity, and <88> Class VI plastic material (refer to the next page for a detailed list of completed tests). Tygon® ND 100-65 is not intentionally made or manufactured with animal derived material.

Features and benefits

crystal clear for easy visualization of fluid flow
ideal for contact with bodily fluids
non-wetting surface permits complete drainage
meets USP Class VI criteria
REACH compliant
withstands EtO, gas and gamma sterilization

Typical applications

minimally invasive devices
Blood and IV solutions
dialysis equipment
wound drainage
inhalation equipment
chemotherapy drug delivery
kidney dialysis pumps
peristaltic pumps
catheters

Dimensions

Tygon® Tube ND 100-65 - Diameters and wall thickness

Art.No.	Ø Inner	Ø Outer	Wall	Inch rounded	Crossref.
TY0,79ND2,38	0,79 mm (1/32")	2,38 mm (3/32")	0,79 mm (1/32")	0,8 x 2,4 x 0,8 mm	ADF00001-C
TY1,59ND3,18	1,59 mm (1/16")	3,18 mm (1/8")	0,79 mm (1/32")	1,6 x 3,2 x 0,8 mm	ADF02002-c
TY1,59ND4,76	1,59 mm (1/16")	4,76 mm (3/16")	1,59 mm (1/16")	1,6 x 4,8 x 1,6 mm	ADF02003-C
TY2,38ND5,56	2,38 mm (3/32")	5,56 mm (7/32")	1,59 mm (1/16")	2,4 x 5,6 x 1,6 mm	ADF00005-C
TY2,38ND3,97	2,38 mm (3/32")	3,97 mm (5/32")	0,79 mm (1/32")	2,4 x 4,0 x 0,8 mm	ADF02004-C
TY3,18ND6,35	3,18 mm (1/8")	6,35 mm (1/4")	1,59 mm (1/16")	3,2 x 6,4 x 1,6 mm	ADF02007-C
TY3,18ND4,76	3,18 mm (1/8")	4,76 mm (3/16")	0,79 mm (1/32")	3,2 x 4,8 x 0,8 mm	ADF02006-C
TY3,97ND7,14	3,97 mm (5/32")	7,14 mm (9/32")	1,59 mm (1/16")	4,0 x 7,1 x 1,6 mm	ADF02010-C
TY3,97ND5,56	3,97 mm (5/32")	5,56 mm (7/32")	0,79 mm (1/32")	4,0 x 5,6 x 0,8 mm	ADF00009-C
TY4,76ND11,11	4,76 mm (3/16")	11,11 mm (7/16")	3,18 mm (1/8")	4,8 x 11,1 x 3,2 mm	ADF00014-C
TY4,76ND6,35	4,76 mm (3/16")	6,35 mm (1/4")	0,79 mm (1/32")	4,8 x 6,4 x 0,8 mm	ADF00011-C
TY4,76ND7,94	4,76 mm (3/16")	7,94 mm (5/16")	1,59 mm (1/16")	4,8 x 7,9 x 1,6 mm	ADF02012-C
TY4,76ND9,53	4,76 mm (3/16")	9,53 mm (3/8")	2,38 mm (3/32")	4,8 x 9,5 x 2,4 mm	ADF00013-C
TY6,35ND11,11	6,35 mm (1/4")	11,11 mm (7/16")	2,38 mm (3/32")	6,4 x 11,1 x 2,4 mm	ADF02018-C
TY6,35ND12,7	6,35 mm (1/4")	12,7 mm (1/2")	3,18 mm (1/8")	6,4 x 12,7 x 3,2 mm	ADF00019-C
TY6,35ND7,94	6,35 mm (1/4")	7,94 mm (5/16")	0,79 mm (1/32")
TY6,35ND9,53	6,35 mm (1/4")	9,53 mm (3/8")	1,59 mm (1/16")	6,4 x 9,5 x 1,6 mm	ADF02017-C
TY7,94ND11,11	7,94 mm (5/16")	11,11 mm (7/16")	1,59 mm (1/16")	7,9 x 11,1 x 1,6 mm	ADF00022-C
TY7,94ND12,7	7,94 mm (5/16")	12,7 mm (1/2")	2,38 mm (3/32")	7,9 x 12,7 x 2,4 mm	ADF00023-C
TY7,94ND14,29	7,94 mm (5/16")	14,29 mm (9/16")	3,18 mm (1/8")	7,9 x 14,3 x 3,2 mm	ADF00024-C
TY9,53ND12,7	9,53 mm (3/8")	12,7 mm (1/2")	1,59 mm (1/16")	9,5 x 12,7 x 1,6 mm	ADF02027-C
TY9,53ND14,29	9,53 mm (3/8")	14,29 mm (9/16")	2,38 mm (3/32")	9,5 x 14,3 x 2,4 mm	ADF02028-C
TY9,53ND15,88	9,53 mm (3/8")	15,88 mm (5/8")	3,18 mm (1/8")	9,5 x 15,9 x 3,2 mm	ADF02029-C
TY11,1ND14,29	11,11 mm (7/16")	14,29 mm (9/16")	1,59 mm (1/16")
TY11,11ND17,46	11,11 mm (7/16")	17,46 mm (11/16")	3,18 mm (1/8")
TY11,11ND15,88	11,11 mm (7/16")	15,88 mm (5/8")	2,38 mm (3/32")	11,1 x 15,9 x 2,4 mm	ADF00033-c
TY12,7ND19,05	12,7 mm (1/2")	19,05 mm (3/4")	3,18 mm (1/8")	12,7 x 19,1 x 3,2 mm	ADF00038-c
TY12,7ND17,46	12,7 mm (1/2")	17,46 mm (11/16")	2,38 mm (3/32")	12,7 x 17,5 x 2,4 mm	ADF02037-C
TY12,7ND15,88	12,7 mm (1/2")	15,88 mm (5/8")	1,59 mm (1/16")
TY14,29ND19,05	14,29 mm (9/16")	19,05 mm (3/4")	2,38 mm (3/32")	14,3 x 19,1 x 2,4 mm	ADF00041-c
TY15,88ND23,81	15,88 mm (5/8")	23,81 mm (15/16")	3,97 mm (5/32")
TY15,88ND22,23	15,88 mm (5/8")	22,23 mm (7/8")	3,18 mm (1/8")	15,9 x 22,3 x 3,2 mm	ADF00046
TY15,88ND20,64	15,88 mm (5/8")	20,64 mm (13/16")	2,38 mm (3/32")
TY19,05ND25,4	19,05 mm (3/4")	25,4 mm (1")	3,18 mm (1/8")	19,0 x 25,4 x 3,2 mm	ADF00053
TY22,23ND28,58	22,23 mm (7/8")	28,58 mm (1-1/8")	3,18 mm (1/8")	22,2 x 28,6 x 3,2 mm	ADF00059
TY25,4ND31,75	25,4 mm (1")	31,75 mm (1-1/4")	3,18 mm (1/8")	25,4 x 31,8 x 3,2 mm	ADF00062

Physical properties

Typical Physical Properties of Tygon® ND 100-65 Tubing

Property	ASTM Method	Value of Rating
Durometer Hardness	D2240	65° Shore A, 15s
Color	-	Clear
Tensile Strength	D412	1,940 psi (14.3 MPa)
Ultimate Elongation	D412	373,00%
Tear Resistance	D1004	32,4 kN/m (185 lb-f/inch)
Specific Gravity	D792	1,19
pression Set, Constant Deflection @158°F (70°C) for 22 hrs.	D395	60,00%
Tensile Modulus, @100% Elongation	D412	817 psi (5.6 MPa)
Maximum Recommended Operating Temperature	-	165 °F (74°C)
Brittlenes by Impact Temperature	D746	-44°F (-42°C)
Water Absorption, % 24 hrs. @ 23°C	D570	0.12

Unless otherwise noted, all tests were conducted at room temperature (73°F). Values shown were determined on 0.075" thick extruded strip or 0.075" thick molded ASTM plaques or molded ASTM durometer buttons.

Tygon® ND 100-65 Characteristics

Tygon® ND 100-65 has met the following test requirements:

Genotoxicity, as described in ISO 10993-3 (Ames Assay 2007)*
Hemocompatibility, as described in ISO 10993-4 (2008)*
In Vitro Platelet Aggregation, as described in ISO 10993-4 (2007)*
Unactivated Partial Thromboplastin Time Assay, as described in ISO 10993-4 (2007)*
Cytotoxicity, as described in ISO-10993-5 (2009)*
Irritation/Sensitization, as described in ISO 10993-10 (2007)*
Plastic Class VI, as described in USP <88> (2022)
Tests for local effects after implantation, as described in ISO 10993-6 (2016)
Tests for systemic toxicity, as described in ISO 10993-11 (2017)
Tests for irritation, as described in ISO 10993-23 (2021)

*Fluid path only

Sterilization Methods

Autoclavable	Yes (steam 30 min at 15 psi, 250°F)
Gas	Yes (Ethylene Oxide)
Radiation	Yes (2.5 Mrad)