Stability Trials (Shelf Life, Expiry and Usage Dates, etc.) for Medical Devices

#1
Hi
This is my first post so I apologise greatly if I have got the wrong forum. (I’ve looked at other forums but can’t seem to find anything very easy to understand….)

I’m looking for some advice on setting up stability trials (shelf life, expiry and usage dates, etc, etc.) The medical device is a
meter and a probe.

One type of probe is built as 20 probes per batch. All the others are built individually.
I need to put together a plan for shelf life studies but not sure how to work out:

- sampling plan for the probes
- acceptance criteria
- confidence limits
- would I perform all the trials on 1 instrument, etc, etc.

I really would appreciate ANY advice AT ALL. (The sensors that we produce are extremely expensive and I’m really worried about not setting up the trial correctly.)


Thanks very much to such a great community!
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Hi
This is my first post so I apologise greatly if I have got the wrong forum. (I’ve looked at other forums but can’t seem to find anything very easy to understand….)

I’m looking for some advice on setting up stability trials (shelf life, expiry and usage dates, etc, etc.) The medical device is a meter and a probe.

One type of probe is built as 20 probes per batch. All the others are built individually.
I need to put together a plan for shelf life studies but not sure how to work out:
- sampling plan for the probes
- acceptance criteria
- confidence limits
- would I perform all the trials on 1 instrument, etc, etc.

I really would appreciate ANY advice AT ALL. (The sensors that we produce are extremely expensive and I’m really worried about not setting up the trial correctly.)

Thanks very much to such a great community!
Any advice?

Thank you!!

Stijloor.
 

pkost

Trusted Information Resource
#3
That's a huge area you are trying to look at and any advice I give is going to be vague because I don't know much detail, however:

- With regards to sampling you may want to look at ISO 2859 Sampling Procedures for Inspection by Attributes
- acceptance criteria, I don't know the product or test, but if there is a standard saying what is acceptable then use this, otherwise the pass/fail is whatever you can justify
- confidence limits - see acceptance criteria
- It is ok to perform multiple tests on one device if you can justify that it will not be detrimental to the test result!

Is the device you are testing sterile? there are a whole load of standards for this!

You mention that the devices are expensive - is there anyway you could use a part manufactured or blank device? For instance in package/sterility trials we can sometimes justify using parts that have failed QC checks in manufacturing or ones that have been part manufactured.
 
#4
Thanks very much for the advice. Yes, the device is sterile.
I will look at a copy of the ISO standard (& get back to you if I have any questions...).

I'm still confused over the formulae for determining minimum sample size for continuous and discrete (proportion) data. If I am to select a sample from a batch, which formula do I use?

Thanks very much again.
 

pkost

Trusted Information Resource
#5
With a sterile device you will also need to look at:
ASTM F1980 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ISO11607 – Packaging for terminally sterilized medical devices

You may also want to look at if appropriate:

ISO 11137-1 - Sterilization of health care products — Radiation

ASTM D5276 - Standard Test Method for Drop Test of Loaded Containers by Free Fall
ASTM F1140 - Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
ASTM F 1886M Determining integrity of seals for flexible packaging by visual inspection
ASTM F 1929 Standard test method for detecting seal leaks in porous medical packaging by dye penetration
 
Thread starter Similar threads Forum Replies Date
D What is the acceptance criteria/requirement for Stability Study? General Measurement Device and Calibration Topics 2
M Device mounted at IV pole - what about mechanical stability testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Use of OQ cleared batch for stability and clinical study use ISO 13485:2016 - Medical Device Quality Management Systems 0
C Surgical mask stability testing (CE mark) EU Medical Device Regulations 2
G Engineering retest in line - Machine stability issues IATF 16949 - Automotive Quality Systems Standard 8
G Accelerated stability of medical devices Other Medical Device Related Standards 1
R Revalidation machine line and Stability Studies impact. Medical Device and FDA Regulations and Standards News 3
S Stability accelerated vs. real-time Other Medical Device Related Standards 3
S Standards for real time stability for medical devices Other Medical Device Related Standards 2
C Medical Device Stability Studies - Non-validated pilot production Other Medical Device Related Standards 1
B Stability testing of medical devices as per ASTM F1980-16 CE Marking (Conformité Européene) / CB Scheme 0
lilybef Number of lots required for stability testing of a Class II device in the 510(k) Qualification and Validation (including 21 CFR Part 11) 3
V System suitability or stability during continuous usage Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
F Extension of a stability study for an API Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
O New stability - Yes or No - Similar product but for different intended use EU Medical Device Regulations 1
A Accelerated Stability Studies - Class III Medical Gloves Other Medical Device and Orthopedic Related Topics 1
ernieto On going Stability for IVDs Other US Medical Device Regulations 5
A Risks related to Method Validation and Stability Studies Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
N Sampling for stability studies - Class II surgically invasive devices Other Medical Device and Orthopedic Related Topics 1
K Food Shelf Life Stability Study Statistical Analysis Tools, Techniques and SPC 1
M Electrosurgical Electrodes - Stability Test Other Medical Device Related Standards 1
C IQ and OQ for a "Dormitory" Refrigerator - Temperature Stability Qualification and Validation (including 21 CFR Part 11) 4
R Holding time stability study of intermediates of drug substances US Food and Drug Administration (FDA) 2
S Stability test - primary packaging EU Medical Device Regulations 7
L MSA - Stability - Part of our PQ (performance qualification) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
C Sample Size for Stability Testing Other Medical Device and Orthopedic Related Topics 2
J EU Medical Device Class I - Stability (Shelf Life) Test EU Medical Device Regulations 2
E EN 13640:2002 or EN23640:2013 For stability testing of in vitro diagnostic reagents ISO 13485:2016 - Medical Device Quality Management Systems 2
M Is a Real Time Stability Study required to determine Expiration Date? EU Medical Device Regulations 9
P Specification and Tolerance in Stability Control Chart Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
P The correct way to do a Linearity and Stability Study on a Critical Dimension Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 8
M How to provide Stability Study for micron-precision tool Misc. Quality Assurance and Business Systems Related Topics 2
R Convincing Management Cpk without Stability is Meaningless Capability, Accuracy and Stability - Processes, Machines, etc. 7
M A question on Measurement System Analysis - Stability to measure got Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
R Drug Stability Data at the time of Filing US Food and Drug Administration (FDA) 3
V Can we apply bracketing & matrixing simultaneously for stability studies @ ICH Q1D US Food and Drug Administration (FDA) 1
M Ownership of Pre-Clinical cGMP Stability Testing Other Medical Device and Orthopedic Related Topics 2
R Shipping Stability for Class III IVD (Non Sterile) Medical Device Other Medical Device Related Standards 7
B How to Demonstrate Stability and Repeatability in very Short Run Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
J How do you perform a S3 Stability Study for a Non-Replicable Measurement System Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
E Company-wide MSA - Measurement Equipment Bias, Linearity & Stability Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
V ICH - Stability studies, alternate conditions... Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
L Stability of the Process vs Improvement during Auditing General Auditing Discussions 8
B Interpretation of Stability Study Data Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
M Are Bias, Stability, and Linearity studies required by TS 16949 7.6.1? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
I Statistical Stability for the PQ of Analytical Equipment Qualification and Validation (including 21 CFR Part 11) 1
L Medical Device Stability Testing Requirements EU Medical Device Regulations 1
R No Stability Standard on latest List of Harmonized Standards IVDD ISO 13485:2016 - Medical Device Quality Management Systems 2
C How to Quantify Significant Change for a Shelf Life Stability Test Other Medical Device Related Standards 15
I Stability Chamber Temperature Mapping General Measurement Device and Calibration Topics 5

Similar threads

Top Bottom