Pharma & Nutraceuticals, NABL-accredited lab
Medical Devices & Surgical Products
10 to 14 working days
Standard turnaround from sample receipt
NABL TC-5843
Accredited to ISO/IEC 17025:2017
Universal testing machine
Primary technique on this service
14,000 sq. ft.
Integrated laboratory in Jaipur
This service checks that a device performs mechanically and is safe in contact with the patient, combining strength, barrier and package integrity testing with sterility, endotoxin, ethylene oxide residue and biocompatibility screening. Each result is reported against the IS or ISO clause the Medical Devices Rules point to.
Registering a device or surgical disposable with CDSCO
Qualifying a sterilisation cycle or a new packaging format
Submitting a hospital or government tender that names test reports
Investigating a field complaint on strength, seal or sterility
What we test on this service
Panels are built from the list below. Tell us the market and the specification and we select the parameters it calls for rather than selling you the whole sheet.
Sterility, bioburden and bacterial endotoxin
Ethylene oxide residues
Tensile strength, elongation and burst pressure
Barrier performance and fluid resistance
Cytotoxicity and biocompatibility screening
Package integrity and seal strength
Method
How the analysis runs
Instrumentation and controls
Every batch runs with the controls its method requires, on calibrated equipment, and a second analyst reviews the data before the report is released.
Standards and methods
Results are reported against the method below, or against your buyer's specification where you send one with the sample.
Ask for the full NABL scope document if you need to confirm accredited coverage before sending the sample.
Not sure which parameters your buyer wants?
Send us the specification. We will tell you what to test and what it costs, at no charge.
The approvals this work is issued under
Testing is carried out under NABL TC-5843 and our CDSCO licence, in the formats used for device registration and for hospital tender qualification.
Before you send it
20 units in intact sterile packaging for each test group, with the device master file reference and the sterilisation method.
10 to 14 working days. Sterility and biocompatibility have fixed incubation periods that cannot be compressed.
Surgical disposable manufacturers
Device importers filing with CDSCO
Hospital procurement and tender evaluation
Packaging suppliers to the device industry
Send a sample
Fill in the Test Request Form, pack the sample as described above and courier it to the Jaipur laboratory. Call us first if the sample is perishable.
Get the TRFRelated queries
Questions we get asked
Do you do full ISO 10993 biocompatibility?
We cover cytotoxicity and the screening battery in house and coordinate the remaining animal-based endpoints through partner laboratories.
How many units do you need per test?
Twenty per test group is the usual requirement. Sterility and biocompatibility need their own units and cannot share with mechanical testing.
Can you test a device already in the market?
Yes. Retail or hospital stock is acceptable provided the packaging is intact and the batch is traceable.
Is ethylene oxide residue testing always needed?
Only where the device is EO sterilised. For gamma or steam sterilised products it does not apply.
Request a quote
Tell us what you need tested
Send the product, the market it ships to and the standard you are being held to. Our technical team replies with the parameter list, the sample quantity we need and a firm turnaround. Quotes usually go out the same working day.
+91-9950229764 / +91-9634063932
Sample receipt: Monday to Saturday, 9:30 am to 6:00 pm