UV Absorption Test - What is it's purpose and what specifically is it looking for?

dore_m

Starting to get Involved
#1
Hello. I'm new to this forum and it looks like I've found a great resource and community for future work....

My company is working on a catheter product that involves plastic, UV glue and needle. We notice that there is a common UV absorption test that needs to be done involving a wavelength range of 250 nm - 320 nm. This test is found in a number of standards, including ISO 8536-4:2010.

Does anyone know the purpose of this test? I mean, what specifically is it looking for?

-Dore
 
Elsmar Forum Sponsor
I

isoalchemist

#2
Re: UV Absorption Test - What is it's purpose and what specifically is it looking for

:2cents:Can you provide a bit more information such as a reference for the testing. I've been out of the labs for too many years but I believe most plastics do not absorb in that range, but the additives would. It may be a "purity" check. At this point its just a guess.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#3
Re: UV Absorption Test - What is it's purpose and what specifically is it looking for

This is also required under IEC 60601-1 and the -2-xxx series. It is looking for damage across the UV range that may occur to the instrument in question. There are additional standards where such radiation testing (and more than UV as well) is required, for example, a specific version of the test is required if a lab wants to have photobiological in the scope of accreditation.

Hope this helps.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: UV Absorption Test - What is it's purpose and what specifically is it looking for

Hi,

It might be for detection of un-cured leftovers of UV curable adhesive.

Since the test is done on an extract solution, I believe it has little to do with the integrity of the infusion set itself.

Cheers,
Ronen.
 

dore_m

Starting to get Involved
#5
Re: UV Absorption Test - What is it's purpose and what specifically is it looking for

Let me try to explain:

The plastic is PP and the needle is stainless steel, sourced from a catheter company. We used commonly used UV curable adhesive (I don't remember which), etc.

We have an official testing house that is telling us that our samples don't pass the test, yet we've sent a set from the same batch to another test house and passed without a problem. I'd have to get with one of more technical people to give more specifics.

-Dore
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Re: UV Absorption Test - What is it's purpose and what specifically is it looking for

Let me try to explain:

The plastic is PP and the needle is stainless steel, sourced from a catheter company. We used commonly used UV curable adhesive (I don't remember which), etc.

We have an official testing house that is telling us that our samples don't pass the test, yet we've sent a set from the same batch to another test house and passed without a problem. I'd have to get with one of more technical people to give more specifics.

-Dore
Hi,

If I had both test houses test reports in front of me, I might have been able to comment. Otherwise, it's just guesswork.

Sorry,
Ronen.
 

dore_m

Starting to get Involved
#7
Re: UV Absorption Test - What is it's purpose and what specifically is it looking for

Ronen-

Thanks for your help. The other day, the official test house called us and just told us over the phone that we didn't pass. We're meeting with them tomorrow to try to get the test data.

But prior to sending our samples to the official test house, we sent to another for pre-confirmation. We have this report, and the curve basically looks like a line descending from (250 nm, 0.076) to (320 nm, .03). We also have the curve from 200nm to 800nm. It looks like an inverse square curve.

The official test house told us over the phone that our level was 0.13/250nm, but did not elaborate. We need below 0.1 to pass. We may not get a report from the official test house - but we can ask for information. Is there something in particular you would recommend?

Again, thanks for your help.

-Dore
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Re: UV Absorption Test - What is it's purpose and what specifically is it looking for

If there is only one report, I don't see where the problem is.

BTW, does the report you have on hand come from a qualified / accredited test house?

Please feel free to send me a private message if there are details you don't wish to expose.

Cheers,
Ronen.
 

dore_m

Starting to get Involved
#9
Re: UV Absorption Test - What is it's purpose and what specifically is it looking for

Since I'm new to the forum, I can't yet send you a PM.....
 
Thread starter Similar threads Forum Replies Date
M Specific Absorption Rate (SAR) Testing - What Standard to Use? Other ISO and International Standards and European Regulations 1
B Machine Shop Yield and Cost - Productivity, Yield and Absorption Performance Manufacturing and Related Processes 3
M How to monitor performance of AAS (Atomic Absorption Spectrometer) Equipment General Measurement Device and Calibration Topics 2
R Surgical Sutures and Absorption - Break strength retention (BSR) properties ISO 13485:2016 - Medical Device Quality Management Systems 1
E Test report to certify compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 2
E Tensile test machine, tinius olsen 602 Manufacturing and Related Processes 1
M Test failure Root cause not found Customer Complaints 10
Moumen H Variations between ASTM A29 Standard for steel bars and Mill test certificates specs Manufacturing and Related Processes 1
D Tip test 10° -> 5° IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Sponsor name presented in the test report EU Medical Device Regulations 4
M Packing Validation & Accelerated Aging Test ISO 13485:2016 - Medical Device Quality Management Systems 2
S OEM full range calibrations vs Validation special test points Medical Device and FDA Regulations and Standards News 0
C IEC 60601 - 8.8.3 Dielectric Strength test. 4kv being applied to the ground conductor?! IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Shelf Life Test for IFU and Implant Card Other Medical Device Related Standards 1
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
S Critical characteristic on manufacturing operations test procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
R IEC 60601-1 Clause 15.3.2, Push test IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Knee Implant (Femoral -Cobalt chrome)-Sub chronic toxicity test (ISO 10993-11)choice of root Medical Device and FDA Regulations and Standards News 2
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
A Is calibration of test weight required General Measurement Device and Calibration Topics 4
S Non parametric test for semi-quantitative data. Statistical Analysis Tools, Techniques and SPC 5
Ed Panek Disaster Recovery Test IT (Information Technology) Service Management 3
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
M Is it normal / sufficient to have only the IEC 60601-1-2 test report without indicating IEC 60601-1? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Z Is Op Amp Common-Mode Rejection Ratio (CMRR) test applicable to battery operated devices? Other Medical Device Related Standards 0
E When to perform accelerated aging studies and transport test(OQ or PQ) Qualification and Validation (including 21 CFR Part 11) 4
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
A Test requirements for marketing in US when RATED values are not of US IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
H Secondary Circuits, Voltage Test and Clearance/Creepage IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Fogging test as per DIN 75201(50ug/g ) VDA Standards - Germany's Automotive Standards 3
R HV Test of HF Surgical Unit IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R IEC 60601-1 - 11.1.3 e) Test criteria - Temperature Measurements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E 60950-1 resistance to abnormal heat test Various Other Specifications, Standards, and related Requirements 0
S User evaluation for self monitoring blood glucose test systems US Food and Drug Administration (FDA) 4
E MSA for Push and Pull test Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
Z IEC 60601-2-25; Frequency response test Medical Device and FDA Regulations and Standards News 1
J Confusing on Harmonic Emissions/Voltage Fluctuations/Flicker test for CISPR 11 Class A Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Routine production tests - dielectric voltage withstand test IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D Difference between Test Method Validation and Gage R&R Qualification and Validation (including 21 CFR Part 11) 18
Crimpshrine13 Laboratory Scope - Calibration vs. Test Methods - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 3
N IEC 60601-1-1 - Stress test, reference voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
E Mentor for Test Method Validation (TMV) Design and Development of Products and Processes 2
L ASQ's Biomedical Auditor Course Test ASQ - American Society for Quality 1
W Regarding Requirement for Hi pot & Leakage Current test Station Set-up IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
R Regulatory Affairs Certification (RAC) prep - Practice test versus actual exam Professional Certifications and Degrees 1
R SAT (System Accuracy Test) temperature according to AMS2750E AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
R MSA for ATE (Automatic Test Equipment Embedded Software) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom