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PRODUCT LINE 02 · MEDICAL & PHARMA

Medical Grade Silicone Tubing
with a documented chain

USP Class VI and ISO 10993 tested tubing, platinum-cured in a controlled area and lot-traced from compound to packed carton. Bores from 0.5 mm for catheter and pump duty.

AT A GLANCE

CompoundPlatinum-cured, medical grade

Hardness30 – 60 Shore A

Temperature−60 to 220 °C

Bore range0.5 – 25 mm ID

SterilisationSteam · EO · gamma

ComplianceUSP Class VI · ISO 10993

WHY THIS SPEC

The tube is the easy part.
The paperwork is the product.

A medical tube programme lives or dies on documentation. Which lot of compound went into which run, what the extractables profile looks like, whether the change you made to the die last month was communicated to the customer before it shipped. We run the extrusion and the record keeping as one process, because a tube without a traceable lot number is not a medical component.

Tubing is produced in a controlled area with filtered air and dedicated tooling, then packed double-bagged. Bores below 2 mm are drawn on a mandrel to hold concentricity, which is where most thin medical tube fails: an off-centre bore changes the pump stroke and the dose with it.

Lot-level traceability

Compound lot, extrusion run, operator shift and packing date recorded per carton.

Extractables on file

USP Class VI and ISO 10993-5/-10 reports per compound family, not per colour.

Controlled production

Filtered air cell, dedicated tooling, no reprocessed regrind in the medical stream.

Change control

Any compound, die or process change is notified before shipment, with a bridge report.

OPTIONS

Four ways to specify it

Same compound family, different construction. Mixing two options on one order is common and usually cheaper than splitting the purchase.

Pump & Infusion Tubing

Tight tolerance bore for volumetric dosing

ID 0.5–8 mm · ±0.05 mm

Drainage & Suction

Soft, kink-resistant, non-collapsing wall

ID 6–19 mm · 1.5–2 mm wall

Multi-Lumen

2–4 lumens for combined delivery and sensing

OD 2–8 mm · custom section

Catheter Shaft

High tear strength, thin wall, radiopaque option

OD 1–6 mm · 30–50 Shore A

WHERE IT RUNS

Applications this line is specified into

Infusion & IV

Dosing lines where bore tolerance drives the delivered volume.

Dialysis

Blood and dialysate paths; verified haemocompatibility data.

Surgical drainage

Soft walls that do not collapse under suction.

Ventilator & respiratory

Breathing circuits, 22 mm and custom connectors.

Drug delivery devices

Low extractables for injectable contact.

Wound care

Single-use sets, EO sterilisable, double-bagged.

DIMENSIONS

Bore, concentricity and wall

Concentricity matters more than wall tolerance on sub-2 mm bore. We hold TIR to 0.08 mm on the drawn sizes and supply a cross-section measurement with the first article.

ID (mm)	OD (mm)	Wall (mm)	Tol. (mm)	TIR (mm)	Shore A
0.5	1.5	0.50	±0.05	0.06	50
1.0	2.0	0.50	±0.05	0.06	50
1.6	3.2	0.80	±0.08	0.08	50
2.4	4.0	0.80	±0.08	0.08	50
3.2	6.4	1.60	±0.10	0.10	50
4.8	8.0	1.60	±0.10	0.10	50
6.4	11.2	2.40	±0.12	0.12	50
9.5	15.9	3.20	±0.15	0.15	50
12.7	19.0	3.20	±0.15	0.15	50

SWIPE TO SEE ALL COLUMNS →

FAQ

Questions engineers ask first

Can you send a USP Class VI report before we order?

Yes, for the compound family you are considering. Reports are per material family; if you need a report on the specific lot that ships to you, that is a separate biological test and adds roughly three weeks.

Which sterilisation methods are compatible?

Saturated steam, ethylene oxide and gamma irradiation. Gamma causes some cross-linking and a small hardness rise; if your dose is above 25 kGy, tell us at the quoting stage so we can start from a softer compound.

How do you handle change control?

A written notification goes out before any change to compound, die, or process that could affect the finished tube. The notification includes a comparison of the affected properties and, where relevant, first-article measurements from both versions.

Is the tubing produced in a cleanroom?

Extrusion runs in a controlled area with filtered air and dedicated tooling, and packing is double-bagged. We are not an ISO 13485 certified device manufacturer; if you need a certified cleanroom extrusion, say so and we will tell you honestly whether the programme fits.

What is the minimum order for a custom bore?

500 m for a new die, 200 m for an existing bore in a medical compound. First articles and a dimensional report are included in the tooling cost.

Send the drawing, not the catalogue number.

Bore, wall, concentricity, sterilisation method and the standard you are designing to. We come back with a compound recommendation, a dimension sheet and the documentation you will need for your technical file.

sales16@yutiansilicone.com
+86 136 6281 5387

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Medical Grade Silicone Tubing with a documented chain

The tube is the easy part. The paperwork is the product.