Test Procedure or Standard for Accelerated Aging for AIMD

B

benderspeck

#1
Hi All,

I am searching for a test procedure or standard to evaluate the electronic lifespan inside our active implantable medical device (not the packaging, but the device itself).

I am looking for something that would be accelerated and take into account body tissue (in saline at 37C). Right now I am looking at subjecting the product to some of the military environmental tests (MIL-STD-202 and MIL-STD-810). Preferably I would like to find an accelerated aging standard that outlines an elevated temperature/cycle that I could use for the product in saline and estimates X years of aging in a human body.

Does anyone know if this exists, or can I modify/justify ASTM1980 for my own purposes?

thanks
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

From a formal point of view, you are on an acceptable path.

From a wise point of view, you better start with an analysis of the possible time-dependent failure mechanisms, that would eventually end the device life (i.e. drive any of its critical characteristics below spec). You can't accelerate something before you define and understand it; even then, some failure mechanisms can't be accelerated in a reliable way.

I already wrote about it in Elsmar: http://elsmar.com/Forums/showthread.php?t=33072

Cheers,
Ronen.
 
M

Murphys Law

#3
From an electronics point of view, the human is a benign environment. It is pretty constant temperatures. The semiconductor should not reach its wearout stage.

Corrosion could be something to consider. Your problems are goings to be more on defect management and designing for low ppms. (You should consider other techniques such as redundancy.)

You should take a read of http://www.inemi.org/project-page/medical-components-reliability-specifications-project-completed

Basically the project was created to fill the gap of industrial methods of qualifying electronics to an medical component one.
 
Thread starter Similar threads Forum Replies Date
S Critical characteristic on manufacturing operations test procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
D Calibration & Test Laboratory Non-Conformance Procedure Example wanted General Measurement Device and Calibration Topics 3
M MetCal procedure for EM Test Devices General Measurement Device and Calibration Topics 1
S ASTM F2179-02 Glass Scratch Test Procedure Requirements Manufacturing and Related Processes 1
S Writing a Test Method Validation Procedure as well as Validation of Test Methods General Measurement Device and Calibration Topics 1
I Process Approach Litmus Test - Procedure Titles ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
L Calibration Procedure for an IC (Integrated Circuit) Test Socket Calibration and Metrology Software and Hardware 6
A Dial Test Indicator Repair Procedure General Measurement Device and Calibration Topics 3
R Identifying "or equivalent" Test Equipment when written in a Procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
B Software Beta Testing - Sample test plan or procedure wanted Other Medical Device and Orthopedic Related Topics 5
L Definition ATP (Acceptance Test Procedure) vs. QTP (Qualification Test Procedure) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
J Procedure for the calibration of Test Indicators and related log sheet General Measurement Device and Calibration Topics 3
G Seeking: Powder Coating on Steel Test Method or Procedure Various Other Specifications, Standards, and related Requirements 10
E Test report to certify compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 1
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
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

Similar threads

Top Bottom