EN 980:2008(E) - Graphical Symbols for Labeling Medical Devices

J

jjcontrol

#1
I need this standard "EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices" Can someone help me with this?
 
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Ajit Basrur

Staff member
Admin
#2
Re: EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices

I need this standard "EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices" Can someone help me with this?
Welcome to the cove

Regarding your request, EN 980 is copyright document and we strictly do not encourage exchangeof copyrighted documents.

You could get EN 980:2008 from various sources like BSI or any other sources.
 
V

vinqua

#3
Re: EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices

Hi JJerez,
You can order it from Tech Street...
 
J

jjcontrol

#4
Re: EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices

Thank you for your help
 
Last edited by a moderator:
J

jjcontrol

#5
Re: EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices

:agree1:Dear Vinqua,

Thank you for your information, I went to Tech Stree web page and I ordered the EN 980:2008....
 
W

Woman on a mission

#6
Re: EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices

Before I invest in a copy does anyone know if there is a symbol in the EN980:2008 to show when a product must be disposed of after opening? The jar symbol with the time in months inside the jar is perfect but I believe this is only for cosmetics and may not be used on medical device packaging. I have written to the MHRA and am awaiting a reply, I thought maybe this forum could answer quicker. Many thanks
 
G

gar4guv

#7
Re: EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices

there is an hourglass symbol for "Use By"

the notes state: "the symbol is intended to indicate that the device should not be used after the end of the month shown or the day, if applicable."
 
W

Woman on a mission

#8
Re: EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices

there is an hourglass symbol for "Use By"

the notes state: "the symbol is intended to indicate that the device should not be used after the end of the month shown or the day, if applicable."
Thanks for your reply, I have this symbol ready for when the new MDD comes into play, but the use by date is the shelf life, I need something which depicts a symbol which shows that the patient needs to throw away the device 6 months after opening the package, which is different to the ´use by´ date. Much the same concept as the open jar on the cosmetic packaging, if this makes sense, :thanx:
 
M

MIREGMGR

#9
Re: EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices

AFAIK, no such symbol is generally recognized.

Note that if you intend to distribute in the US, symbolic communication without an associated text message is highly restricted by the FDA anyway.
 

bio_subbu

Super Moderator
#10
Re: EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices

Thanks for your reply, I have this symbol ready for when the new MDD comes into play, but the use by date is the shelf life, I need something which depicts a symbol which shows that the patient needs to throw away the device 6 months after opening the package, which is different to the ´use by´ date. Much the same concept as the open jar on the cosmetic packaging, if this makes sense, :thanx:
Hi

Find attached guidance document “NB-MED/2.2/Rec3, “Use-by“ date for Medical Devices” Hope, this guidance will give better idea.

Thanks and Regards
S. Subramaniam
 

Attachments

Thread starter Similar threads Forum Replies Date
bio_subbu EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices ISO 13485:2016 - Medical Device Quality Management Systems 4
B Was EN 980:2008 superseded by EN 15223-1:2012 on January 31, 2013 CE Marking (Conformité Européene) / CB Scheme 2
L Medical Device Labeling Requirements - EN:980:2008 Other Medical Device Regulations World-Wide 2
C Where can I download the EN 980:2008 Medical Device IFU Symbols? Other Medical Device Related Standards 16
Y Consultation: EN 980 still recognized by EU regulation? EU Medical Device Regulations 4
rob73 When will BS EN ISO 15223-1:2012 replace EN 980 EU Medical Device Regulations 2
J Symbol for manufacturing date - Is ISO 980 expired? CE Marking (Conformité Européene) / CB Scheme 11
M BS EN ISO 15223-1:2012 replaces EN 980 - What is the effect of the change? Quality Manager and Management Related Issues 44
B Do we need to put the box around the SN symbol listed in EN 980? Other ISO and International Standards and European Regulations 5
L Use of the EN 980 Manufacturer Symbol CE Marking (Conformité Européene) / CB Scheme 3
B Need guidance for getting EN 980 Medical Symbols Other Medical Device Related Standards 2
R Use of EN 980 and ISO 15223 Symbols for Non Medical Mevices Other Medical Device Related Standards 6
R Text associated with EN 980 Symbols Other Medical Device Related Standards 10
T EN 1041 or EN 980 - Need Documents Please! EU Medical Device Regulations 2
I BS EN 1041 - BS EN 980 - BS EN ISO 14630 revisions - What are the changes Other Medical Device Related Standards 4
N CE Marking MDD & EN 980 Labeling Requirements, IFU, Packaging, etc. EU Medical Device Regulations 6
C ISO 15223 or EN 980 - What standard should be used in CE technical file? EU Medical Device Regulations 9
S Graphical Symbols - EN 980 - Labeling of Medical Devices and EN 60601-1 Symbols Other Medical Device Related Standards 17
S Is using ANSI/ASQ Z1.4-2008 the correct sampling plan to determine Pass/Fail of Apparel measurements? AQL - Acceptable Quality Level 4
A ISO 10993-7:2008/ Amd.1:2019 - Classification of special populations Other Medical Device Related Standards 3
Q What is the ISO 9001:2008 certificate status after 15 Sep 2018? Registrars and Notified Bodies 7
qualprod What is the difference between 7.4.1 (2008) and 8.4.1 (2015)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Surveillance Audit of 2008 before Transition Audit to ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
T ISO 9001:2008 to 2015 transition - How much work to change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
G Upkeep of ISO 9001:2008 during Transition TO ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Sidney Vianna IAF Ruling - No more ISO 9001:2008 nor ISO 14001:2004 audits after 2018-03-15 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
W Internal Approval of Deviations - ISO 9001:2008 & ISO 13485:2003 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
D Internal Audit During the Transition Period from ISO9001:2008 to ISO9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Customer Audit - Root Cause Help - ISO 9001:2008 Cl. 7.5.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q Incorrectly Performed ISO 9001:2008 Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Total number of Requirements for ISO 9001:2008 vs. ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
P ISO 9001:2008 Design and Development Process & Forms examples wanted Design and Development of Products and Processes 3
P Need a new video for employee training ISO 9001:2008 Training - Internal, External, Online and Distance Learning 6
J ISO 9001:2008 - Can I still conduct Internal Audits in my company? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Objective and Goals - ISO 9001:2008 Frequency Revision Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
C Internal Auditing Requirements (ISO 9001:2008) Internal Auditing 3
Q Drawings from Client - ISO 9001:2008 Clause 4.2.3 or 7.5.4? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C Process Map Transition from ISO9001:2008 to ISO9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
C ISO 9001:2008 Surveillance Audit - No Internal Audits Internal Auditing 9
P Small company of approx 28 Employees - ISO-9001:2008 Guidelines ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T TS16949 - What extras over the ISO 9001:2008? Gap Analysis IATF 16949 - Automotive Quality Systems Standard 5
P Tasked to change ISO 9001:2008 to ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Verification instead of calibration?(ISO 9001:2008) Calibration Frequency (Interval) 10
D Comparison of ISO 9001:2008 and CAN3-Z299.3 Other ISO and International Standards and European Regulations 1
K Must I update the Quality Policy? (ISO 9001:2008) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
C ISO 9001:2008 to 2015 Transition Training ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A Tailored ISO 9001:2008 for DLA (AS9100) (AS9003) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
C Checklist comparison between ISO9001:2008 and ISO 3834 Quality Management System (QMS) Manuals 1
Marc ISO 9001:2015 vs. 2008 - Internal Audits - What changes are you making? Internal Auditing 44
B Global / Local Management Review - ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8

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