Standard Medical Device (Health) Icons?

D

dcrawfe

#1
While researching medical icons, I stumbled across the site and thought maybe someone could help. I am a new employee at a medical device company and I've been given the task of determining if there are internationally recognized, standard medical (health) icons.

Somewhere in my searching, I did see a standard for medical symbols; however, I am unfamiliar with the details of ISO standards. If I purchase this standard, should I expect that it will contain all standardized medical icons - or- will it be a text document explaining what the standards are? Ideally, I'd like to see the icons, of course.

Also, please keep in mind, while the icons I am interested in will appear on a medical device, the icons themselves are not entirely "medical" in nature. For example, I need an icon for stress, exercise, diet, etc.

I'd really appreciate it if anyone can point me in the right direction. Thanks.
 
Elsmar Forum Sponsor

chris1price

Trusted Information Resource
#3
Re: Standard Medical (Health) Icons?

Hi

If your looking at symbols for CE Marking in Europe, the only harmonised standard is EN980:2003. This has symbols for

  • Do not Reuse
  • Use By
  • Batch Code / Lot Number
  • Serial Number
  • Date of manufacture
  • Sterile (+method)
  • Catalogue Number
  • Caution, Consult accompanying documents
  • Manufacturer
  • EU Representative
  • IVD
  • Temperature Limits

If you use any other symbols, you should translate the meaning.
 

Le Chiffre

Quite Involved in Discussions
#5
Re: Standard Medical (Health) Icons?

should I expect that it will contain all standardized medical icons - or- will it be a text document explaining what the standards are? Ideally, I'd like to see the icons, of course.
To answer this question, yes, ISO 15223 does have the icons, but not much more information than the symbol font file that Wes posted. It's still not defined when they should be used, how big (or small) they can be on the label.

While we're on the topic, I purchased ISO 15223:2000 and now see there's a 2007 version. Anyone know the differences? I don't feel like paying another $50...
 

Avraham Harris

Involved In Discussions
#6
Re: Standard Medical (Health) Icons?

Does anyone know on which inner packaging the Date of Manufacture must appear if it appears on the outer box (an IVD)?
 
S

Shamann2

#7
Which standard to purchase?

I am interested in purchasing ISO 15223:2007 or 980 if they actually contain the symbols that can be used for label drawings. Too many times I've purchased a standard only to find out that it refers to another standard that actually has the info that I need. Does anyone know the answer? What else would you recommend as a resource?

Thanks,
Sue
 
A

Adele

#8
There is a 2008 version of EN980 available.

When you say "they actually contain the symbols that can be used for label drawings" what do you mean specifically?

If you mean an electronic version with the symbols in various formats for you to use, then no - the versions you purchase from standards organisations won't contain this. But you can source these from some standard and other organisations.

If you mean you only need them if they contain the symbols that are relevant to your labelling, then you need to do some research on that.

There are a number of symbol standards. Which ones you get depend upon your device(s) specific requirements. I think at a minimum you will need ISO 15223-1 and EN 980. If your device is electrical you then need to consider symbols for electrical equipment. You may also want to consider ISO 7000 which is a more general symbol standard and may be useful for packaging symbols.
 
M

MIREGMGR

#9
Re: Which standard to purchase?

I am interested in purchasing ISO 15223:2007 or 980 if they actually contain the symbols that can be used for label drawings.
EN980 is available from various sources in an optical-disk form (i.e. CD-ROM) containing both images of the text document of the standard itself, and copyable computer artwork of the symbol set.

See for instance http://www.bsigroup.com/Shop/Publication-Detail/?pid=000000000030194914.

The above is offered by a particular vendor, with whom I have no business connection. I mention them only as an example...I'm sure that other standards-sellers offer the same product.
 

bio_subbu

Super Moderator
#10
Re: Standard Medical (Health) Icons?

Hi

If your looking at symbols for CE Marking in Europe, the only harmonised standard is EN980:2003. This has symbols for

  • Do not Reuse
  • Use By
  • Batch Code / Lot Number
  • Serial Number
  • Date of manufacture
  • Sterile (+method)
  • Catalogue Number
  • Caution, Consult accompanying documents
  • Manufacturer
  • EU Representative
  • IVD
  • Temperature Limits

If you use any other symbols, you should translate the meaning.
Hi
I would like to update the information, the current version is EN 980:2008 (Symbols for use in the labeling of medical devices)
 
Thread starter Similar threads Forum Replies Date
U Leakage test Standard for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
P Medical device testing lab/service standard Other Medical Device Related Standards 1
N Is there a standard / rules pertaining to eating in medical device manufacturing area? Manufacturing and Related Processes 5
P Usability/human factors engineering requirement (standard) for IVD medical device Other Medical Device Related Standards 2
G Electrical Safety standard for medical device not covered by IEC 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Q JIS T 1115 Comparison (Japan Medical Device Standard) Japan Medical Device Regulations 0
F Which Medical Device Standard Registrar would you recommend? CE Marking (Conformité Européene) / CB Scheme 5
S Medical Device Clinical Evaluation Standard Operating Procedure / SOP Document Control Systems, Procedures, Forms and Templates 12
S Medical Device Clinical Evaluation Standard Operating Procedure / SOP Imported Legacy Blogs 1
S Medical Device Reporting SOP (Standard operating procedure) example Other Medical Device and Orthopedic Related Topics 1
R Is there a mandatory medical device warehouse standard for europe? EU Medical Device Regulations 3
M Partial Compliance to an ISO Standard for Medical Device CE Marking EU Medical Device Regulations 13
J Quality Procedure to handle some standard Medical Device Processes Document Control Systems, Procedures, Forms and Templates 1
A Classification of Medical Device with Partial Compliance with a particular standard IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
G Old Medical Device Equipment - Compliance with New or Old Standard - What to do? Other Medical Device Related Standards 3
W EN ISO 15225 (2010) - Medical Device Nomenclature - A Harmonized Standard? EU Medical Device Regulations 1
R Regulation/Standard for Labelling in the UK - Medical Device Directions for Use ISO 13485:2016 - Medical Device Quality Management Systems 7
E Reference Standard for Shelf Life Testing of Packaging for Sterilized Medical Device Other US Medical Device Regulations 3
Marc ISO 13485 - Medical Device Quality Management System Standard ISO 13485:2016 - Medical Device Quality Management Systems 30
D FMEA with 2 or 3 criteria? Standard applicable to the Medical Device industry ISO 14971 - Medical Device Risk Management 13
P Version of Medical device safety standard - IEC 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
G Medical Device Choke Hazard standard or guidance ISO 13485:2016 - Medical Device Quality Management Systems 2
lilybef A standard that gives requirements for medical device transportation studies? Other ISO and International Standards and European Regulations 7
A Which Standard Regulates Dirt, Fibers, Hairs, etc. on/in a Medical Device? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
S Usability standard IEC 60601-1-6 in the Medical Device Industry IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
A QC (Quality Control) Visual Standard for Medical Device Product ISO 13485:2016 - Medical Device Quality Management Systems 7
T Suppliers Registered to Automotive Standard Who Manufacture Medical Device Components Supplier Quality Assurance and other Supplier Issues 4
J Standard for Packing and Transport of Sterilized Medical Devices Various Other Specifications, Standards, and related Requirements 2
S Clinical evaluation standard operating procedure / SOP for medical devices Document Control Systems, Procedures, Forms and Templates 1
P Amendment 1 to 60601-1, 3rd Edition Medical Electrical Equipment Standard IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
N Medical Devices - Standard Format for Barcoding in EU Other Medical Device Related Standards 2
S 12 Volt Medical Suction Equipment - Which Standard Applies? Other Medical Device Related Standards 4
bio_subbu ISO 15223-2 for safer use of symbols with Medical Devices - Released new standard Other Medical Device Related Standards 1
triathlonx13 ISO vs. ANSI Thread Standard (Dimensions) and Luer Taper for Medical Devices Various Other Specifications, Standards, and related Requirements 4
S Medical Gas Change Over Unit - Which Standard to use? Other Medical Device Related Standards 4
M Cal 133 flammability standard - Medical Devices - Stupid Customer Tricks 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
N Which standard is applicable for IR LED in conjunction with medical devices? Other Medical Device Related Standards 6
A ISO 15189 - International Standard for Medical/Clinical Labs Other ISO and International Standards and European Regulations 1
W Soldering Standard - What is the soldering standard used for medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 12
T Which ISO Standard is relevant for Refurbished Medical Devices? ISO 13485:2016 - Medical Device Quality Management Systems 3
Ajit Basrur Mold Material Standard - Material for making molds supporting medical devices ISO 13485:2016 - Medical Device Quality Management Systems 10
A ISO 15189:2003 - Standard for Medical Laboratories ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
D Oil and Gas product standard Oil and Gas Industry Standards and Regulations 0
T Operator Acceptance Audit Standard AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
L Annex of ISO 13485:2016 as harmonized standard (MDR/IVDR) ISO 13485:2016 - Medical Device Quality Management Systems 2
D Is ISO 10993-1:2020 a Harmonized Standard? Other Medical Device Related Standards 3
D Is it required to have the operator initial their work in the IATF 16949:2016 standard? IATF 16949 - Automotive Quality Systems Standard 3
S FCC Part 15, 18 harmonized to a standard? Various Other Specifications, Standards, and related Requirements 3
H Is CLSI H7-A3:2000 standard edition currently valid? Other Medical Device Related Standards 0
N Upgrading obsolete standard - how to? General Measurement Device and Calibration Topics 3

Similar threads

Top Bottom