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ISO 10993 Biocompatibility for Medical Silicone Tubing: Cytotoxicity, Sensitization, Irritation
2026-10-20 12:57:29
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ISO 10993 is the international standard family for biological evaluation of medical devices. This guide explains what cytotoxicity, skin sensitization and skin irritation reports cover, why oxygen concentrator tubing benefits from them, how ISO 10993 differs from USP Class VI, and how to request the reports with your order.
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Technical Guide · Biocompatibility
ISO 10993 is the international standard family for the biological evaluation of medical devices. For our medical grade silicone tubing we reference three test reports — cytotoxicity, skin sensitization and skin irritation — each answering a different question about the material. They are available on request, in addition to ISO 13485 quality-system documentation.
| Standard familyISO 10993Biological evaluation | Reports referencedThreeCytotoxicity · sensitization · irritation | System documentationISO 13485On request | ProductionClass 100,000Cleanroom |
What each of the three tests covers
ISO 10993 is a family of standards, not a single certificate. What ISO 10993 silicone tubing documentation contains is a set of reports, each describing one biological endpoint. Which endpoints apply depends on how the material contacts the body: gas carried to a patient and a cleaning agent carried inside a machine are not evaluated with the same scope.
The three reports below are the set we reference for our medical silicone tubing. They are material-level tests: each works on an extract prepared from the material under defined conditions, not on a finished assembly.
| Report | Question it answers | How the test works, in principle |
|---|---|---|
| Cytotoxicity | Do extracts of the material harm cells? | Cells are cultured, exposed to a prepared extract, and their response is graded. |
| Skin sensitization | Could the material provoke a sensitization response? | The extract is applied in a controlled test system to see whether a sensitization response is produced. |
| Skin irritation | Does the material produce local irritation? | The extract is applied to skin or a skin model, and the local response is scored. |
Cytotoxicity
Cytotoxicity is the broadest of the three questions, which is why it is usually the first report a quality file asks for: if extracts of a material harm cells, little else in the biological evaluation matters. In principle the test prepares an extract of the silicone at a defined surface-area-to-volume ratio in a defined vehicle, exposes cultured cells to it, and grades their response.
For a tube, this asks what the material releases into the extract, not what a data sheet says. The report is evidence about that extract under those conditions, not a certificate for the finished assembly.
Skin sensitization
Sensitization is a different question from irritation: a material can irritate without sensitizing, and a sensitization response typically develops after repeated contact rather than on first exposure. The test asks whether the material can provoke such a response, using the prepared extract in a controlled system — a predictive test on the material, not a clinical trial.
For tubing it matters because of repeated contact. In a home-care circuit the tube is handled daily, coiled, stored and replaced as a consumable, and the cannula rests against skin. Procurement files for home-care devices therefore often ask about sensitization potential specifically.
Skin irritation
Irritation is the local, short-term response at the contact site: whether the material produces a local reaction, again using the extract under defined conditions. Its practical relevance is the part of the circuit that touches skin or mucosa.
None of the three is a pass mark for a device. Each describes how the material behaved in one defined test, which is why we present all three together and do not extend the list: if a file needs an endpoint we hold no report for, we say so at the enquiry stage. What a buyer can file is the report for each endpoint.
Why oxygen concentrator tubing benefits from this
The case for a biocompatibility silicone hose is easiest to see at the end of a concentrator circuit. Gas leaves the device, travels through braided silicone tubing for oxygen concentrators, and reaches the cannula or mask. The tube is the last polymer the breathing gas touches, and in home care it is also the part the patient handles most.
"Medical silicone" is a material description; biocompatibility testing turns it into evidence of how an extract of that material behaved in defined biological tests.
One construction detail keeps the scope honest. Our braided medical hose is a platinum-cured silicone liner, a reinforcement braid and a silicone cover. The liner is the gas-contact surface and the braid sits outside it, so the report that matters for the gas path is the report on the liner material.
The limits deserve stating as plainly as the benefits. These are material-level tests: device-level biological evaluation, contact duration, cleaning cycles and any regulatory submission stay with the device manufacturer.
ISO 10993 vs USP Class VI — what is the difference?
They are different systems, and a device file may reference one, the other, or both.
ISO 10993 is an international family of standards for the biological evaluation of medical devices. It is organised around the device and its contact with the body: the type and duration of contact determine which endpoints are relevant, and the output is a set of test reports for those endpoints. USP Class VI is a classification of plastic materials in the United States Pharmacopeia, built on a defined set of biological reactivity tests.
| ISO 10993 | USP Class VI | |
|---|---|---|
| What it is | International standard family for biological evaluation of medical devices | A classification of plastic materials in the United States Pharmacopeia |
| Organised around | The device and its contact with the body | The material and a defined set of biological reactivity tests |
| What you receive | Test reports for the endpoints in scope | A material classification with the data behind it |
| What to ask for | The reports for the endpoints your file lists | The material classification, and the tests behind it |
For our tubing the position is simple: we do not hold or claim USP Class VI, and we do not describe our silicone as USP Class VI material. What we provide is the ISO 10993 side — the three reports named on this page — together with ISO 13485 quality-system documentation and cleanroom production.
If your file is written around USP Class VI, say so at the enquiry stage: it is a different evidence set, and better to know before the specification is fixed. Medical device biocompatibility files work the same way — the useful question is not which logo a supplier shows but which report covers which material, under which conditions. That is what medical grade silicone tubing certification should mean in practice: a document set you can trace, not a badge.
What we can provide, and how to request it
Cleanroom production, ISO 10993 biocompatibility reports and ISO 13485 can be provided according to customer requirements.
The ISO 10993 test reports, a COA and a TDS can travel with a quotation or a shipment; the third column shows the requirement each answers.
| Document | What it covers | Where it fits in your file |
|---|---|---|
| ISO 10993 cytotoxicity report | Cytotoxic response in the extract test | Biological evaluation — cytotoxicity endpoint |
| ISO 10993 skin sensitization report | Sensitization potential of the material | Biological evaluation — sensitization endpoint |
| ISO 10993 skin irritation report | Local irritation response to the material | Biological evaluation — irritation endpoint |
| Certificate of analysis (COA) | Batch-level results for the delivered lot | Incoming inspection and lot release |
| Technical data sheet (TDS) | Construction, dimensions, hardness, temperature range | Specification and drawing review |
What to send with the request — six lines are enough for a precise answer:
- Construction and size, with wall thickness or hardness if fixed.
- The application, and where the tubing sits.
- The documents your file lists — three reports, COA, TDS, or a subset.
- Destination country, if the documents feed a regulatory submission.
- Any tolerance, colour or packaging requirement affecting the material.
- The date your file needs the documents by.
A biocompatibility report is issued against the material, not an order number, so one report covers every size built from that material. The reports describe the silicone, the COA is batch-specific, the TDS describes the construction.
On timing: in-stock samples ship in 3 days, standard items are 5–7 days, and custom builds are typically 10–20 working days. The material is platinum-cured silicone rated −40 °C to +200 °C, and like our other medical silicone hose ranges it is not for human implant.
Frequently asked questions
What are the three ISO 10993 tests you reference?
Cytotoxicity, skin sensitization and skin irritation. Each answers a different question about the material: whether extracts harm cells, whether the material could provoke a sensitization response, and whether it produces local irritation. We name the ISO 10993 three tests in full rather than quoting a standard number alone.
Can you provide the reports with a quotation?
Yes. Cleanroom production, ISO 10993 biocompatibility reports and ISO 13485 can be provided according to customer requirements. Send the construction, the size and the list of documents your file needs, and we will confirm what applies to the material you are ordering, with the COA and TDS.
Do you hold USP Class VI?
No. USP Class VI is a classification in the United States Pharmacopeia, and a different evidence set from ISO 10993; we do not hold or claim it. We provide the ISO 10993 side — cytotoxicity, skin sensitization and skin irritation reports — plus ISO 13485 documentation and cleanroom production when your file requires them.
Why does oxygen concentrator tubing need biocompatibility reports?
The tube is the last polymer the breathing gas touches before the cannula, and in home care it is handled and replaced as a consumable. A file that qualifies a concentrator or a replacement circuit usually asks for material documentation; the three reports and a batch COA are the usual answer.
How do I request the test reports?
Send one message with the construction and size, the application, and the documents your file lists, plus the destination country if the documents feed a regulatory submission. In-stock samples ship in 3 days, standard items are 5–7 days and custom builds are typically 10–20 working days.
Related reading
- Braided silicone hose for oxygen concentrators — how an oxygen concentrator hose is specified on a circuit.
- Burst pressure and vacuum ratings in braided silicone hose — the pressure side of the same construction.
- Silicone oxygen supply tubing — the product range this documentation applies to.
Next step
Tell us the construction and size, the application and the documents your file lists. If your file is built around a different scheme, say so in the first message; we will tell you what we hold and what we do not.
Need the biocompatibility reports for your tubing order?
Send the construction, size and document list, and we will confirm which of the three ISO 10993 reports apply.
DongGuan Yutian Silicone Rubber Technology Co., Ltd (Yutian Silicone) — silicone extrusion manufacturer since 2012. 6,800 m² facility · 14 extrusion lines · 4 calendering lines · 7 compression moulding lines · Class 100,000 cleanroom · monthly capacity up to 8,000,000 meters. Room 801, Building 10, No. 2 Tutang Industrial 2nd Heng Road, Changping Town, Dongguan, Guangdong, China. Contact: Brown · +8618028921514 · salesmanager@yutiansilicone.com
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Dongguan Yutian Silicone Rubber Technology Co., Lt
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ISO 10993 Biocompatibility for Medical Silicone Tubing: Cytotoxicity, Sensitization, Irritation
Author：Dongguan Yutian Silicone Rubber Technology Co., Lt
Technical Guide · Biocompatibility
ISO 10993 is the international standard family for the biological evaluation of medical devices. For our medical grade silicone tubing we reference three test reports — cytotoxicity, skin sensitization and skin irritation — each answering a different question about the material. They are available on request, in addition to ISO 13485 quality-system documentation.
| Standard familyISO 10993Biological evaluation | Reports referencedThreeCytotoxicity · sensitization · irritation | System documentationISO 13485On request | ProductionClass 100,000Cleanroom |
What each of the three tests covers
ISO 10993 is a family of standards, not a single certificate. What ISO 10993 silicone tubing documentation contains is a set of reports, each describing one biological endpoint. Which endpoints apply depends on how the material contacts the body: gas carried to a patient and a cleaning agent carried inside a machine are not evaluated with the same scope.
The three reports below are the set we reference for our medical silicone tubing. They are material-level tests: each works on an extract prepared from the material under defined conditions, not on a finished assembly.
| Report | Question it answers | How the test works, in principle |
|---|---|---|
| Cytotoxicity | Do extracts of the material harm cells? | Cells are cultured, exposed to a prepared extract, and their response is graded. |
| Skin sensitization | Could the material provoke a sensitization response? | The extract is applied in a controlled test system to see whether a sensitization response is produced. |
| Skin irritation | Does the material produce local irritation? | The extract is applied to skin or a skin model, and the local response is scored. |
Cytotoxicity
Cytotoxicity is the broadest of the three questions, which is why it is usually the first report a quality file asks for: if extracts of a material harm cells, little else in the biological evaluation matters. In principle the test prepares an extract of the silicone at a defined surface-area-to-volume ratio in a defined vehicle, exposes cultured cells to it, and grades their response.
For a tube, this asks what the material releases into the extract, not what a data sheet says. The report is evidence about that extract under those conditions, not a certificate for the finished assembly.
Skin sensitization
Sensitization is a different question from irritation: a material can irritate without sensitizing, and a sensitization response typically develops after repeated contact rather than on first exposure. The test asks whether the material can provoke such a response, using the prepared extract in a controlled system — a predictive test on the material, not a clinical trial.
For tubing it matters because of repeated contact. In a home-care circuit the tube is handled daily, coiled, stored and replaced as a consumable, and the cannula rests against skin. Procurement files for home-care devices therefore often ask about sensitization potential specifically.
Skin irritation
Irritation is the local, short-term response at the contact site: whether the material produces a local reaction, again using the extract under defined conditions. Its practical relevance is the part of the circuit that touches skin or mucosa.
None of the three is a pass mark for a device. Each describes how the material behaved in one defined test, which is why we present all three together and do not extend the list: if a file needs an endpoint we hold no report for, we say so at the enquiry stage. What a buyer can file is the report for each endpoint.
Why oxygen concentrator tubing benefits from this
The case for a biocompatibility silicone hose is easiest to see at the end of a concentrator circuit. Gas leaves the device, travels through braided silicone tubing for oxygen concentrators, and reaches the cannula or mask. The tube is the last polymer the breathing gas touches, and in home care it is also the part the patient handles most.
"Medical silicone" is a material description; biocompatibility testing turns it into evidence of how an extract of that material behaved in defined biological tests.
One construction detail keeps the scope honest. Our braided medical hose is a platinum-cured silicone liner, a reinforcement braid and a silicone cover. The liner is the gas-contact surface and the braid sits outside it, so the report that matters for the gas path is the report on the liner material.
The limits deserve stating as plainly as the benefits. These are material-level tests: device-level biological evaluation, contact duration, cleaning cycles and any regulatory submission stay with the device manufacturer.
ISO 10993 vs USP Class VI — what is the difference?
They are different systems, and a device file may reference one, the other, or both.
ISO 10993 is an international family of standards for the biological evaluation of medical devices. It is organised around the device and its contact with the body: the type and duration of contact determine which endpoints are relevant, and the output is a set of test reports for those endpoints. USP Class VI is a classification of plastic materials in the United States Pharmacopeia, built on a defined set of biological reactivity tests.
| ISO 10993 | USP Class VI | |
|---|---|---|
| What it is | International standard family for biological evaluation of medical devices | A classification of plastic materials in the United States Pharmacopeia |
| Organised around | The device and its contact with the body | The material and a defined set of biological reactivity tests |
| What you receive | Test reports for the endpoints in scope | A material classification with the data behind it |
| What to ask for | The reports for the endpoints your file lists | The material classification, and the tests behind it |
For our tubing the position is simple: we do not hold or claim USP Class VI, and we do not describe our silicone as USP Class VI material. What we provide is the ISO 10993 side — the three reports named on this page — together with ISO 13485 quality-system documentation and cleanroom production.
If your file is written around USP Class VI, say so at the enquiry stage: it is a different evidence set, and better to know before the specification is fixed. Medical device biocompatibility files work the same way — the useful question is not which logo a supplier shows but which report covers which material, under which conditions. That is what medical grade silicone tubing certification should mean in practice: a document set you can trace, not a badge.
What we can provide, and how to request it
Cleanroom production, ISO 10993 biocompatibility reports and ISO 13485 can be provided according to customer requirements.
The ISO 10993 test reports, a COA and a TDS can travel with a quotation or a shipment; the third column shows the requirement each answers.
| Document | What it covers | Where it fits in your file |
|---|---|---|
| ISO 10993 cytotoxicity report | Cytotoxic response in the extract test | Biological evaluation — cytotoxicity endpoint |
| ISO 10993 skin sensitization report | Sensitization potential of the material | Biological evaluation — sensitization endpoint |
| ISO 10993 skin irritation report | Local irritation response to the material | Biological evaluation — irritation endpoint |
| Certificate of analysis (COA) | Batch-level results for the delivered lot | Incoming inspection and lot release |
| Technical data sheet (TDS) | Construction, dimensions, hardness, temperature range | Specification and drawing review |
What to send with the request — six lines are enough for a precise answer:
- Construction and size, with wall thickness or hardness if fixed.
- The application, and where the tubing sits.
- The documents your file lists — three reports, COA, TDS, or a subset.
- Destination country, if the documents feed a regulatory submission.
- Any tolerance, colour or packaging requirement affecting the material.
- The date your file needs the documents by.
A biocompatibility report is issued against the material, not an order number, so one report covers every size built from that material. The reports describe the silicone, the COA is batch-specific, the TDS describes the construction.
On timing: in-stock samples ship in 3 days, standard items are 5–7 days, and custom builds are typically 10–20 working days. The material is platinum-cured silicone rated −40 °C to +200 °C, and like our other medical silicone hose ranges it is not for human implant.
Frequently asked questions
What are the three ISO 10993 tests you reference?
Cytotoxicity, skin sensitization and skin irritation. Each answers a different question about the material: whether extracts harm cells, whether the material could provoke a sensitization response, and whether it produces local irritation. We name the ISO 10993 three tests in full rather than quoting a standard number alone.
Can you provide the reports with a quotation?
Yes. Cleanroom production, ISO 10993 biocompatibility reports and ISO 13485 can be provided according to customer requirements. Send the construction, the size and the list of documents your file needs, and we will confirm what applies to the material you are ordering, with the COA and TDS.
Do you hold USP Class VI?
No. USP Class VI is a classification in the United States Pharmacopeia, and a different evidence set from ISO 10993; we do not hold or claim it. We provide the ISO 10993 side — cytotoxicity, skin sensitization and skin irritation reports — plus ISO 13485 documentation and cleanroom production when your file requires them.
Why does oxygen concentrator tubing need biocompatibility reports?
The tube is the last polymer the breathing gas touches before the cannula, and in home care it is handled and replaced as a consumable. A file that qualifies a concentrator or a replacement circuit usually asks for material documentation; the three reports and a batch COA are the usual answer.
How do I request the test reports?
Send one message with the construction and size, the application, and the documents your file lists, plus the destination country if the documents feed a regulatory submission. In-stock samples ship in 3 days, standard items are 5–7 days and custom builds are typically 10–20 working days.
Related reading
- Braided silicone hose for oxygen concentrators — how an oxygen concentrator hose is specified on a circuit.
- Burst pressure and vacuum ratings in braided silicone hose — the pressure side of the same construction.
- Silicone oxygen supply tubing — the product range this documentation applies to.
Next step
Tell us the construction and size, the application and the documents your file lists. If your file is built around a different scheme, say so in the first message; we will tell you what we hold and what we do not.
Need the biocompatibility reports for your tubing order?
Send the construction, size and document list, and we will confirm which of the three ISO 10993 reports apply.
DongGuan Yutian Silicone Rubber Technology Co., Ltd (Yutian Silicone) — silicone extrusion manufacturer since 2012. 6,800 m² facility · 14 extrusion lines · 4 calendering lines · 7 compression moulding lines · Class 100,000 cleanroom · monthly capacity up to 8,000,000 meters. Room 801, Building 10, No. 2 Tutang Industrial 2nd Heng Road, Changping Town, Dongguan, Guangdong, China. Contact: Brown · +8618028921514 · salesmanager@yutiansilicone.com
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