ISO 15223-1 Sterile barrier system - The 3-layer symbol

kunal9218

Starting to get Involved
#1
Hi, I was referring the Sterile Barrier Association's guidance document and came across this and also it says:
Note: The 3-layer symbol has been validated, but will not be part of ISO 7000.
Capture.PNG

So, does this mean I can't use this symbol. I have a product where the inner carton box serves as a protective packaging outside and have two sterile barrier pouches inside.
Thoughts?
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
K ISO 15223-1 Do Not Reuse and Do Not Resterilize Other Medical Device Related Standards 5
B Does EN ISO 15223-1:2016 include the graphic symbols to be added to software and IFU? Other Medical Device Related Standards 9
A MDRS Standards Harmonisation - copy of ISO 15223-1 EU Medical Device Regulations 3
J ISO 15223-1: Keep dry vs. humidity limitation label symbol Other Medical Device Related Standards 2
E Where can I buy ISO-15223-1 CD with graphic symbols? Other Medical Device Related Standards 13
E ISO 15223-1 (Medical Device Label Symbols) - Revisions, EU commission? Other ISO and International Standards and European Regulations 1
K EN ISO 15223-1:2012 Clarification or Examples on when to use Safety Symbols Other Medical Device Related Standards 3
R Is BS EN ISO 15223-1 a harmonised standard? EU Medical Device Regulations 2
rob73 When will BS EN ISO 15223-1:2012 replace EN 980 EU Medical Device Regulations 2
renenatasha BS EN ISO 14971:2012, BS EN 62366:2008 and BS EN 15223-1:2012 Questions EU Medical Device Regulations 12
M BS EN ISO 15223-1:2012 replaces EN 980 - What is the effect of the change? Quality Manager and Management Related Issues 44
R Use of EN 980 and ISO 15223 Symbols for Non Medical Mevices Other Medical Device Related Standards 6
bio_subbu ISO 15223-2 for safer use of symbols with Medical Devices - Released new standard Other Medical Device Related Standards 1
C ISO 15223 or EN 980 - What standard should be used in CE technical file? EU Medical Device Regulations 9
R Device Labeling Standards: Is ISO 15223:2000 Replacing EN980? ISO 13485:2016 - Medical Device Quality Management Systems 3
T ISO 13485 - 5.5.1 Responsibility and authority - Small Company Independence ISO 13485:2016 - Medical Device Quality Management Systems 13
A Refusal to discuss ISO 9001 obligations... what to do? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
B Can we be ISO 9001 certified without a physical office? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
J Informational ISO 24971:2020 Released ISO 14971 - Medical Device Risk Management 0
S ISO 45001 and outsourcing the transporation of products Occupational Health & Safety Management Standards 2
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
A Question on ISO 14001:2015 - Are annual audits required? ISO 14001:2015 Specific Discussions 8
N Which EN ISO 17664 version compliance to EU MDR? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
Sidney Vianna Informational New edition of ISO 29001 released (June 2020) Oil and Gas Industry Standards and Regulations 0
R Who is the customer in the ISO/IEC 17025:2017? ISO 17025 related Discussions 1
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
L Combining 3 ISO 9001 registrations into 1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Risk Analysis Flow - Confusion between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 7
C Compliance with ISO 17025 requirement 8.4.2 - Controls - Records recovery ISO 17025 related Discussions 4
N EN ISO 13640:2002 vs EN ISO 23640:2011 Other Medical Device Related Standards 1
O ISO 13485 vs. GMP - Comparison matrix wanted EU Medical Device Regulations 0
A ISO 10002:2018 Checklist Needed (Complaints Handling) Customer Complaints 5
N Sampling Plan for Internal Audits - ISO 2859 or 3951 - Or Neither? Internal Auditing 6
O ISO 13485 - Is management review required before stage 1? ISO 13485:2016 - Medical Device Quality Management Systems 6
BeaBea ISO 9001 Customer Feedback Methods - What has worked for your company? Service Industry Specific Topics 16
O In addition to the standard, what other ISO 13485 sources do people recommend? ISO 13485:2016 - Medical Device Quality Management Systems 5
Watchcat ISO 13485 for IVD (In-vitro Diagnostic Device) Manufacturers? ISO 13485:2016 - Medical Device Quality Management Systems 9
G New to ISO 9001 - Where to begin? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 35
G ISO 17025-2017 Management Review reporting items - Inputs ISO 17025 related Discussions 1
F Logistics and IT clauses in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Q Automation in manufacturing - Print Shop ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
B ISO 14971 Applied to Software ISO 14971 - Medical Device Risk Management 2
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 11
V Quality Objectives - ISO 9001 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
H ISO 13485:2016 Gap Analysis by NB ISO 13485:2016 - Medical Device Quality Management Systems 7
Gun46 ISO 9001 : 2015 Lead Auditor Exam General Auditing Discussions 5
Q ISO 9001:2015 man days for surveillance audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Similar threads


















































Top Bottom