Standard guide for shelf life determination of non sterile component with degradation materials

#1
Hi,

We have a non sterile single use component that is attached to the medical device which has materials that degrades with time. We are intending to perform real time and accelerated aging testing. What standard should I use for aging conditions? ASTM F1980 is for sterile devices. Is there any for non-sterile ones?
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
ASTM F1980 is intended for the sterile barrier. It has little to do with sterility itself.
There is no other accelerated ageing published standard that I'm aware of.
Do you understand the mechanism of degradation in the subject component? That's the key. If it's a chemical reaction of order 0 or 1 you may be able to use the Arrhenius equation or the simplified Q10 model that is based on it (i.e. generally follow F1980). Otherwise you'll have to develop and validate your own rational model.
No, actually you may elect to act irrationally... When it comes to accelerated ageing, this seems to be the norm.
 
Thread starter Similar threads Forum Replies Date
M A Guide or Standard for Calibration Interval (Frequency) Calibration Frequency (Interval) 2
J What Standard/s can a tourist guide be certified to? Service Industry Specific Topics 4
D Seeking Equipment Verification Standard Procedure books/guide/links Book, Video, Blog and Web Site Reviews and Recommendations 1
V ASTM E2476 - 09 Standard Guide for Risk Assessment ...of PAT processes for pharma FMEA and Control Plans 1
G Standard to use as a guide in measuring surface "roughness" of aluminum tubing General Measurement Device and Calibration Topics 1
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
Y UL 1998 Standard: software classes Software Quality Assurance 0
G What to do with correction factors overlooked by an accredited standard (6.4.11)? ISO 17025 related Discussions 5
G Copy of withdrawn ISO 9001:1994 Quality Management Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Anonymous16-2 SOP (Standard Operating Procedure) Numbering Document Control Systems, Procedures, Forms and Templates 7
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3
Skooma Deburring and Tolerances - Is there a Standard for deburring or removing material? Manufacturing and Related Processes 3
B Purchasing AS9100D Standard in Japanese AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
O In addition to the standard, what other ISO 13485 sources do people recommend? ISO 13485:2016 - Medical Device Quality Management Systems 5
B ASTM E18-2020 - Rockwell testing standard changes? General Measurement Device and Calibration Topics 2
M Informational RoHS Standard - EN 63000:2018 to replace EN 50581:2012 Medical Device and FDA Regulations and Standards News 11
M IEC 60601-1 1988 - Device developed in 2012 with standard of 1988 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
P Cenelec updated standard information CE Marking (Conformité Européene) / CB Scheme 1
S Is there a standard for sample size during R&D phase Other ISO and International Standards and European Regulations 18
J Standard used to determine if check fixture gauge is acceptable Reliability Analysis - Predictions, Testing and Standards 2
N Program or application for standard time measurement in industry from video surveillance? Human Factors and Ergonomics in Engineering 1
I Where can I beg, steal (just kidding of course) or borrow good training material on the ISO 9001:2015 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Question on whether IEC 60601-2-62 standard is applied IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
B Clause 5.1.12 of Technical Standard IEC 62304/A1 IEC 62304 - Medical Device Software Life Cycle Processes 5
M Viable count Measurement ISO Standard Other Medical Device Related Standards 1
I When exactly was "competence" added to the ISO-9001 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S Managing specification changes on standard parts purchased through trading companies Document Control Systems, Procedures, Forms and Templates 2
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
S Average and standard deviation of Cumulative Data Statistical Analysis Tools, Techniques and SPC 5
R Standard Filter for Calibration Colorimeter ISO 17025 related Discussions 1
B Standard for Dielectric Strength Test IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Specific Absorption Rate (SAR) Testing - What Standard to Use? Other ISO and International Standards and European Regulations 1
M Harmonised RED Standard ETSI EN 440 - Which Version? Other ISO and International Standards and European Regulations 0
R QMS Standard appilications on different Defense Sector Quality Management System (QMS) Manuals 1
A Supplier Quality Standard vs Senior Management Direction Supplier Quality Assurance and other Supplier Issues 2
B To detect the non standard variable IATF 16949 - Automotive Quality Systems Standard 5
J What is the minimum standard for automotive component traceability? Manufacturing and Related Processes 2
B Need For BIS Standard Mark? Imported OEM's Power supply,Li-Ion Battery Other Medical Device Regulations World-Wide 0
C On spontaneous but non-standard rankings FMEA and Control Plans 3
E Post Market Surveillance Standard Various Other Specifications, Standards, and related Requirements 4
A IEC 60601-2-2 - Defib-proof test amendment to base standard IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N Is there a standard / rules pertaining to eating in medical device manufacturing area? Manufacturing and Related Processes 5
M Performance Standard for Balloon Trocars Other Medical Device Related Standards 2
D Using "Particle Size Standard" templates as gauges - How to avoid giving a gauge # while using for process control? General Measurement Device and Calibration Topics 2
S Where to get online AS standard audit certification classes? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P ISO 10993-1:2018 - When will the European equivalent become a Harmonized Standard? Other Medical Device Related Standards 13
M Informational From AAMI – FDA Recognizes AAMI Standard and TIR Medical Device and FDA Regulations and Standards News 0
S Implementing a 45001 Health & Safety standard - Internal audit plan wanted Internal Auditing 1
S CTS/CSE Waveforms Testing - Partial Recognition of IEC 60601-2-25 Standard by FDA IEC 60601 - Medical Electrical Equipment Safety Standards Series 3

Similar threads

Top Bottom