Biocompatibility Testing (ISO 10993)

Show that the materials in your device are safe for the body they touch, with a test plan based on the type and duration of contact.

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How Biocompatibility Testing (ISO 10993) works

1Assessment of requirement
2Sample collection
3Right lab assigned
4Testing
5Test report

Each step explained

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Overview of Biocompatibility Testing (ISO 10993)

Tested by: NABL-accredited partner lab
Regulation: ISO 10993 & MDR 2017
Typical turnaround: 3–8 weeks
Sample needed: Finished, sterilised devices

Any device or material that touches a patient, from gloves and catheters to implants and dressings, needs a biological evaluation to ISO 10993-1. The standard asks you to plan tests by type of contact (skin, mucosa, blood, tissue, bone) and duration (under 24 hours, up to 30 days, or longer), and to start with chemical characterisation of the materials.

The basic set for most devices is cytotoxicity, sensitisation and irritation. Devices with longer or deeper contact add systemic toxicity, genotoxicity, implantation and haemocompatibility. Tests are done on the finished, sterilised device, because processing and sterilisation can change what leaches out. Results support the device master file in CDSCO applications and technical files for export.

What we do for you

Lab and parameter list chosen for your purpose: licence, export, buyer or internal QC
Sampling guidance, and pickup or on-site sampling where needed
One contact who follows up with the lab until the report is issued
Report explained in plain language, with next steps if a result fails

What to send

The lab confirms the exact quantity and packing for your product when we book the test.

Sample

Quantity: Finished, sterilised devices
Sealed and labelled with the product name, batch number and date
Packed securely so that it is not damaged in transit

Details to share

Device name, intended use and risk class under the Medical Device Rules
Materials, parts that contact the patient and duration of contact
Instructions for use, labels and any existing test reports
Markets where the device will be sold

How we handle Biocompatibility Testing (ISO 10993)

1
Assessment of requirement
We confirm the standard, the list of tests and how many samples your product needs.
2
Sample collection
We collect the samples from your factory or warehouse, or tell you exactly where to send them.
3
Right lab assigned
We choose an accredited lab (NABL, BIS-recognised or ILAC) that covers your standard and can start soonest.
4
Testing
The lab tests your samples against the standard. We follow up and tell you at once if a test fails.
5
Test report
You receive the signed test report, ready to use for BIS, WPC, CE or your buyer.

What the lab tests

Parameter	Why it is checked
Cytotoxicity (ISO 10993-5)	Effect on cells, the first screen
Sensitisation (ISO 10993-10)	Allergic reactions
Irritation (ISO 10993-23)	Skin and mucosal irritation
Acute systemic toxicity (ISO 10993-11)	Effects beyond the contact site
Haemocompatibility (ISO 10993-4)	Blood-contacting devices
Chemical characterisation (ISO 10993-18)	What the materials release

The final list depends on your product, its standard and the purpose of testing. We confirm it with you before the sample goes to the lab.

Frequently asked questions

Do we need every ISO 10993 test?

No. The tests depend on how and for how long the device contacts the body. A risk-based plan, supported by chemical characterisation and existing data on the materials, often reduces the number of animal and in vitro tests needed.

Will CDSCO accept the report?

Testing is done at labs accredited by NABL for the standard, or registered under the Medical Device Rules where your application needs it. We confirm what your licence application, tender or export market asks for before testing.

Who carries out the testing?

Instacertify’s partner laboratories, accredited by NABL to ISO/IEC 17025 for the parameters on your report. We choose the lab, arrange the sample, follow up until the report is issued and explain the results to you.

What our clients say

“Instacertify helped us get BIS CRS certification for our entire product range within just 6 weeks. Their team handled everything from documentation to lab coordination. Highly professional service.”

Akash GuptaBIS CRS · Electronics brand

“They handled complete certification for us, from ISO 9001 to BIS for PVC cables and plugs. Thorough, professional and always available — they knew what needed to be done and when.”

Shivank VishnoiISO 9001 & BIS · Cables

“Getting TEC approvals for our access-control products seemed confusing and complex, but Instacertify made it simple.”

Jiten ShahTEC approval · Access control

Not sure which certification you need?

Send us the product name and the countries you sell in. A specialist replies with the standards that apply, the documents to prepare, the lab cost and the timeline. The assessment is free.

The list of approvals comes to you in writing
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