How to decide which medical device symbols go on label and labeling?

SGquality

Quite Involved in Discussions
#1
This question is always in my mind - the ISO 15223 has so many symbols but how to decide which medical device symbols go on product, product label, primary packaging, and so on?
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
This question is always in my mind - the ISO 15223 has so many symbols but how to decide which medical device symbols go on product, product label, primary packaging, and so on?
First, identify what information has to be on/in each of the labelling elements. This is mostly driven by applicable regulatory/statutory and customer requirements.
Then you may consider using symbols - for space considerations, translation avoidance or other reasons.
Last, use applicable standards to identify the correct symbols and use them in a compliant manner.
You don't have to use any symbol unless the regulations explicitly require it.
 
#4
Specific question in regards to single use labeling - is single use labeling required? For example a class 1 medical device that practitioners routinely clean, sterilize, and re-use although the labeling may not specify "single-use only" or "multi-use" Is it acceptable to not make either single use or multiuse claim on label?
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Specific question in regards to single use labeling - is single use labeling required? For example a class 1 medical device that practitioners routinely clean, sterilize, and re-use although the labeling may not specify "single-use only" or "multi-use" Is it acceptable to not make either single use or multiuse claim on label?
If the device requires reprocessing and this is not clearly stated in the labelling it's a safety issue, most likely unacceptable.
 
#6
Adding to what Yodon has mentioned, it's up to the manufacturer to decide how much is enough. The standards for e.g. IEC 60601-1 layout the principles/context of application, some of them depend on the device. Most importantly before asking “how many”, manufacturers should do a risk management of the application as stated in ISO 15223-1. For e.g., if the device is intended for home use then depending on the user profile a symbol may be misunderstood/ignored leading to an adverse event (AE).
 
Thread starter Similar threads Forum Replies Date
C Medical Device Manufacturing in Controlled Environment? How to decide? Other Medical Device Regulations World-Wide 1
silentmonkey How to decide what characteristics need to be verified during incoming inspection? ISO 13485:2016 - Medical Device Quality Management Systems 5
J ISO 9001 - How to decide if a company needs or will benefit from certification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
L Help me to decide which test to use - If each proportion belongs to the same population Using Minitab Software 7
T Can we remove a quality objective if we decide it is not measurable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
B How to decide on a sampling size for Xbar-R charts Statistical Analysis Tools, Techniques and SPC 2
J How to decide work-stream in scope of Quality - Roles and Responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 1
D Service Identification - How can we decide if X is a service or not? Lean in Manufacturing and Service Industries 4
R How to decide a suitable contact time from table 23 of IEC 60601-1:2005 IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
M Statistical Method to decide Threshold Value from a Data Set Statistical Analysis Tools, Techniques and SPC 1
P Gauge Design Tolerances - How to decide tolerances for gauge design? General Measurement Device and Calibration Topics 3
C Starting an MSA study - How to decide which is appropriate or required Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
S Lean or Six Sigma or TOC (Theory of Constraints) - How to decide Lean in Manufacturing and Service Industries 6
H How to decide AQL value? Sampling Plans AQL - Acceptable Quality Level 5
A Who to decide and select Internal Auditors and what are the criteria? Internal Auditing 18
M CAPA Rankings to decide if action is required Nonconformance and Corrective Action 7
D Who should decide on my salary and adjustments? Career and Occupation Discussions 9
P How do you decide what is an acceptable Internal and External PPM number? IATF 16949 - Automotive Quality Systems Standard 17
M Overhaul QMS or start over? How do you decide? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 40
P How do you decide what is a Process, a Procedure or Work Instruction? Document Control Systems, Procedures, Forms and Templates 89
J To Decide Which Factor has the Highest Influence on the Results Using Minitab Software 3
K Regulatory Requirements for ISO 13485 - Which country to decide? ISO 13485:2016 - Medical Device Quality Management Systems 6
B How to decide the ?U? to calcuate DPU and "opportunity" of DPMO Six Sigma 8
L Is the EPA is going to decide if the SPCC deadline is to be extended? Miscellaneous Environmental Standards and EMS Related Discussions 1
M CA (corrective action) or Continuous Improvement? It's hard to decide. Nonconformance and Corrective Action 19
M how to decide the submission level for PPAP APQP and PPAP 2
Y How do we use SPC or other stat tools to decide product spec? Statistical Analysis Tools, Techniques and SPC 5
D On-going capability - Can we decide for ourselves how often to measure cpk? Capability, Accuracy and Stability - Processes, Machines, etc. 6
dgrainger Informational MHRA's Software and AI as a Medical Device Change Programme UK Medical Device Regulations 0
dgrainger Informational Consultation on the future regulation of medical devices in the United Kingdom UK Medical Device Regulations 0
S Medical Device - Technical Documentation structure EU Medical Device Regulations 1
JoCam On-product labels for Medical Devices EU Medical Device Regulations 3
LostLouie Archived Specifications and Drawings for Medical Device Technical Files EU Medical Device Regulations 2
B Reprocessing of an accessory for a medical device EU Medical Device Regulations 4
V Taiwan - Veterinary medical devices Other Medical Device Regulations World-Wide 1
K System of medical devices EU Medical Device Regulations 0
A Class 1 medical device - Thailand Other Medical Device Regulations World-Wide 0
D Dental application - medical product or not? Other US Medical Device Regulations 8
P Interchangeable/alternative parts in BOM (medical device) Manufacturing and Related Processes 4
U Is Initial Importer Status Required if a Medical Device is Manufactured and Sterilized by an OEM in the US Other US Medical Device Regulations 1
B Research Use Only (RUO) IVD Medical Devices in China China Medical Device Regulations 2
J Shoe Covers - medical device class I EU Medical Device Regulations 3
A Are pipette heads "medical devices"? ISO 13485:2016 - Medical Device Quality Management Systems 9
J Software as a Medical Device - SaMD IEC 62304 - Medical Device Software Life Cycle Processes 3
R QMS for Medical products & Pharmaceutical Drugs in one facility Medical Device and FDA Regulations and Standards News 3
C CE Marking - Medical Device Accessories EU Medical Device Regulations 0
H Existing cloud based medical device - questions regarding improving the processes IEC 62304 - Medical Device Software Life Cycle Processes 6
L EOL milestone in Medical Devices Regulations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
U EN 455-4 Accelerated Shelf Life tests for Medical Gloves Other Medical Device Related Standards 2
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3

Similar threads

Top Bottom