Labeling/Marking Location for BF Symbol

Thread Attachment browser
Q

QM Becky

Involved In Discussions
#1
#1
Hi Everyone, Hoping for a bit of guidance on the use of the BF symbol for on product identification.

We have a product in development that will require BF marking. During a review yesterday it became apparent that the location requirement for the on product marking may be difficult to achieve given the configuration of the device and an associated cover (think cell phone case).

Is the BF symbol REQUIRED to be located next to the connection point, or is it acceptable to be on the device in a visible location?

Appreciate any insight or guidance you all can provide.
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
P

Pads38

Trusted Information Resource
#2
#2
Clause 7.2.10 (of 60601-1 Ed 3.1)
...all APPLIED PARTS shall be marked with the relevant symbol,

The relevant symbol shall be marked adjacent to or on the connector for the APPLIED PART unless either:
...no connector, in which case... shall be on the APPLIED PART; or
- the connector is used for more than one AP with different classifications.

Clause 7.2.1 Minimum Requirements for marking
If the size...does not allow affixation of all markings...then at least the markings...7.2.10

Where no marking...is practicable...may be affixed to...packaging.

From all that I would suggest that a BF symbol adjacent to the relevant connector has to be 'high priority' - even if it means leaving of other symbols / information (eg IP rating - 7.2.9).
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
P Class 1 Medical Device Labeling and CE Marking Requirement EU Medical Device Regulations 8
J Marking (Labeling) Requirements on Medical Equipment per IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
C Class I Medical Devices - Country of Origin Marking on Retail Packaging (Labeling) Other US Medical Device Regulations 4
I MDD: CE Marking Labeling Requirements - Two questions... CE Marking (Conformité Européene) / CB Scheme 7
B Labeling for FDA and CE Marking EU Medical Device Regulations 1
T Part 880.5100 AC-powered adjustable Hospital Bed - Applied Parts Marking or Labeling Other US Medical Device Regulations 1
C 7.5.5 Preservation of Product - Marking and Labeling AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
N CE Marking MDD & EN 980 Labeling Requirements, IFU, Packaging, etc. EU Medical Device Regulations 6
D Labeling requirements for reagents, etc ISO 13485:2016 - Medical Device Quality Management Systems 4
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 0
Anonymous16-2 Labeling Question (Dietary Supplements/Food) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
L Medical-grade power adapter labeling Other US Medical Device Regulations 2
Y Labeling difference for storage and operating conditions EU Medical Device Regulations 1
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
S Special 510(K) - Labeling change from Rx to OTC Other US Medical Device Regulations 11
N Device Labeling - Medtronic Ventilator Files (Risk Management documents) Coffee Break and Water Cooler Discussions 2
JoCam Labeling to Customer Requirements EU Medical Device Regulations 1
Z Labeling for Medical Device Samples - Surgical instruments 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Change Control - Product Name Change and its associated labeling EU Medical Device Regulations 7
D Do User Manuals (Not Device Labeling) HAVE to be in their national languages for these countries? Will English Hardcopy not do? EU Medical Device Regulations 12
S How to decide which medical device symbols go on label and labeling? US Food and Drug Administration (FDA) 4
M MDR Legacy Medical Device Labeling compliance timeline EU Medical Device Regulations 3
M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0
M Labeling for off-label use - Prevention of off-label use of a medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Informational US FDA Final Guidance – Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations Medical Device and FDA Regulations and Standards News 0
P UDI labeling for power module IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
A Labeling - 2017/745 - EUMDR Requirements and Trademark Issues EU Medical Device Regulations 0
DitchDigger UDI, Labeling Accessories, General Insanity, Etc. US Food and Drug Administration (FDA) 1
K Labeling requirements - Date of manufacture for software devices EU Medical Device Regulations 5
E Annotated US Prescribing Labeling US Food and Drug Administration (FDA) 0
T Product Labeling - Modified the name of one of our products EU Medical Device Regulations 5
M Informational US FDA draft guidance – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Medical Device and FDA Regulations and Standards News 0
T Labeling Requirements - Creams in tubes EU Medical Device Regulations 3
K EU MDR Art. 22 - Device + insertion pack - User manual and Labeling EU Medical Device Regulations 4
M MDR 2017/745 sterile and non-sterile labeling EU Medical Device Regulations 12
M Professional Use Medical Software French Labeling for Canada -- Not Considered Medical Device Canada Medical Device Regulations 2
CPhelan Labeling template on QMS - Kitting and labeling documentation Manufacturing and Related Processes 9
G FDA UDI markings "label" vs. "labelling" (labeling)? US Food and Drug Administration (FDA) 4
G How is the labeling of units cleared for both Rx and OTC uses handled? US Food and Drug Administration (FDA) 4
E FDA Supplier Labeling Requirements ISO 13485:2016 - Medical Device Quality Management Systems 1
L Class IIa Medical Device, CE Mark & 510k - Labeling Content CE Marking (Conformité Européene) / CB Scheme 4
M Scrubbed version of a labeling procedure that is MDR compliant wanted EU Medical Device Regulations 3
M UDI labeling MDR requirement for reusable medical device accessories EU Medical Device Regulations 12
T Change to Country of Origin on Medical Device Labeling Other Medical Device Regulations World-Wide 0
L EU-MDR-Annex I - 10.4 (CMR & Endocrine-disrupting properties) - Labeling Content EU Medical Device Regulations 5
I Medical Device Packaging Multilingual Labeling EU Medical Device Regulations 3
T FDA proposed labeling standalone software cloud based US Food and Drug Administration (FDA) 4

Similar threads

Top Bottom