No Defined Shelf Life/Expiration Date - Disposable single-use, non-invasive, non-sterile

#1
The product in question is disposable single-use, non-invasive, non-sterile. This product in the past would have been considered an unclassified accessory. There is no guidance on this accessory and no corresponding product code.

My question is whether or not we need shelf life data or if a justification/rationale would be sufficient? The materials are known as non-degradable and there are no foreseeable environmental/storage conditions that would lead to any sort of breakdown affecting safety or effectiveness. For labeling would manufacturing date and no expiration date be sufficient?
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#3
I don't know the answer to your specific question, but...

Do you have all this documented in your Risk File? Also consider transport conditions and excursions from normal storage temperature ranges.
 
Thread starter Similar threads Forum Replies Date
G Remote support - IATF allowed words defined? IATF 16949 - Automotive Quality Systems Standard 11
J Example of a defined procedure for carrying out Material Review Board (MRB) Manufacturing and Related Processes 0
J Action Not defined in procedure - NC - Incoming inspection AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
J Controlled information versus defined documents / records ISO 13485:2016 - Medical Device Quality Management Systems 3
M Is there any pre-defined Control plan format/template acc. VDA? VDA Standards - Germany's Automotive Standards 1
C Design and implementation of process audits as defined within IATF 16949 IATF 16949 - Automotive Quality Systems Standard 2
S How are Medical Device Components and Subassemblies defined? ISO 13485:2016 - Medical Device Quality Management Systems 1
Mikishots Definition Defined - Definition and meaning of "defined" Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 10
E Defined Roles in Small Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
A Short Term vs. Long Term SPC Study - Where is Cp and Cpk Defined Statistical Analysis Tools, Techniques and SPC 8
P Validation of Processes - What is meant by 7.5.6 (a) - Defined Criteria for Review ISO 13485:2016 - Medical Device Quality Management Systems 7
J Measuring Leakage Currents with IEC 60601 defined Measurement Device (MD) IEC 60601 - Medical Electrical Equipment Safety Standards Series 15
R Technical Files Sampling Rule defined in NBOG 2009-4 EU Medical Device Regulations 2
J What results need to be defined in IATF 16949 Clause 8.3.4 IATF 16949 - Automotive Quality Systems Standard 3
J Deformation specification not defined in print Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
S How others have defined "reaudits"? 21 CFR Part 820.22 Internal Auditing 1
R Property - What is defined as Property in ISO 14971 ISO 14971 - Medical Device Risk Management 4
C AS9100 Requirement Definition - Defined vs. Documented AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
X Are defined roles and responsibilities mandatory for ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Root Cause of 'Supplier Evaluation Not defined' Nonconformance and Corrective Action 15
J Is painting considered a Special Process as defined by ISO 9001 7.5.2? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
sagai Preventive Action vs. Corrective Action as defined by 21CFR820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
A How is Segregation of Duties defined in the IT World? IEC 27001 - Information Security Management Systems (ISMS) 4
Q Must Support Processes have defined KPI's (Key Performance Indicators)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K What constitutes (is defined as) as a Medical Device? Other Medical Device and Orthopedic Related Topics 3
Chennaiite External Audit re-defined Imported Legacy Blogs 4
B Definition Diagnostic - Is "diagnostic" defined in the EU Medical Device Standards? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 10
H Document Control Defined? Determining what documents must be controlled ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
V QbD Approach - What are the "New Processes" to be "Defined / Introduced" US Food and Drug Administration (FDA) 6
kedarg6500 What is the meaning of "define/defined" in ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
S No Process Defined to Capture the Special Requirements of Customers Problem Solving, Root Cause Fault and Failure Analysis 10
G How is a Medical Device defined in the EU? ISO 13485:2016 - Medical Device Quality Management Systems 2
Q Suspect Product: How can Suspect Product be defined? TS 16949 IATF 16949 - Automotive Quality Systems Standard 15
G SEI CMMI Dev v1.3 - Defined (ML2) and Managed (ML3) Process Areas Software Quality Assurance 1
T TS 16949 Internal Audit Effectiveness Defined Internal Auditing 5
V Definition Documented versus Defined Procedures Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 5
J Control of Outsourced Processes defined within the Quality Management System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
I Does a QMS defined by the element-by-element approach meet the intent of 4.1a? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
T A confusing Non-conformity - No defined QMS processes intended for 'Management' ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
A Defined intervals for review of quality system documents? Document Control Systems, Procedures, Forms and Templates 13
S Non-conformance regarding Lean Process - Lean Process is not defined ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
P Specified stages of design and development shall be defined - TS 16949 clause 7.3.4.1 IATF 16949 - Automotive Quality Systems Standard 4
M Common tools defined Funny Stuff - Jokes and Humour 3
C Measurement of Uncertainty ?as defined by the US Pharmacopeia? Measurement Uncertainty (MU) 9
P Defined Records Retention Time Of Customer/Regulatory Requirements Records and Data - Quality, Legal and Other Evidence 4
A Accepted / litigated AQLs in the Automotive Industry? Where is this defined? AQL - Acceptable Quality Level 7
C Definition Internal Laboratory as defined in TS16949 - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 14
G Customer Complaint(s) - Can what a Customer Complaint is be defined? Customer Complaints 34
apestate Poorly Defined Product Requirements - ISO 9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Manix GD&T Dimensional Control Frames - How the tolerance is defined Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8

Similar threads

Top Bottom