BS EN ISO 15223-1:2012 replaces EN 980 - What is the effect of the change?

M

Mondo 22

#1
BS EN ISO 15223-1:2012 replaces EN980 at the end of this month.

Does anyone forsee any impact with this?
 
Elsmar Forum Sponsor

rob73

looking for answers
#3
Mondo
Actually you have until January 31st 2013 when BS EN 980 get withdrawn (as stated in the 31st July 2012 corrigenium I recieved this morning).
I cannot see a huge difference between them, other than the inclusion of an extended range of infusion/transfusion symbols.
Rob
 
D

drewsky1

#4
I also do not see much of a change as the symbols are the same with the titles but I would be interested to hear others perception of this standard.
 
S

SteveK

#5
BS EN ISO 15223-1:2012 replaces EN980 at the end of this month.

Does anyone forsee any impact with this?
As an addition to the comments made, one minor obvious impact will be that you will need to update Standard references in product Technical Files (i.e. before EN 980 expires - keeping up with 'state of the art').:2cents:

Steve
 
D

drewsky1

#7
We are having a difference of opinion about any requirement that may be in place from the directive that harmonized symbols need to be translated. We are looking at the updated EN ISO 15233 that will go into effect January 31, 2013. I understood that if a symbol was harmonized that it would not need to be translated in the labeling. However, others feel it is a requirement of the MDD to translate a symbol even if it is harmonized. I thought that was one of the purposes of harmonized symbols in that translation not be required and the symbol should be well known in all markets. I realize that some regulations may override this standard in that respect, but as a rule translation is not required for harmonized symbols. Any input would be appreciated.

Thanks
 
A

AimeeC

#8
re an earlier post in this thread:

"We are looking at the updated EN ISO 15233 that will go into effect January 31, 2013."

***Where is the EN ISO effectivity date posted?***
I would love to get a copy to use as justification for updating my QS documents, etc.:agree:

Thanks.
ac
 
A

AimeeC

#9
Mondo
Actually you have until January 31st 2013 when BS EN 980 get withdrawn (as stated in the 31st July 2012 corrigenium I recieved this morning).
I cannot see a huge difference between them, other than the inclusion of an extended range of infusion/transfusion symbols.
Rob
Hi Rob,

Where can I get a document with the effectivity date of EN ISO 15223-1?
 
C

cspofford1

#10
I see lots of comments on EN 980:2008 being withdrawn as of Jan 31, 2013 but as of today this information is not listed on the EUROPA website .

Neither is the introduction of ISO 15223-1:2012 as a new harmonized standard.

Does anyone see something I am missing? I find it very doubtful that the EU would withdraw EN 980:2008 that quickly after the release of ISO 15223-1:2012.
 
Thread starter Similar threads Forum Replies Date
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
K EN ISO 15223-1:2012 Clarification or Examples on when to use Safety Symbols Other Medical Device Related Standards 3
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
A ISO/DIS 15223-1:2020 - Country of manufacture label (IEC 60417 No. 6049) - Which national law requires this symbol? Other Medical Device Related Standards 0
S ISO 15223-1:2020 Symbols Other Medical Device Related Standards 1
K ISO 15223-1 Do Not Reuse and Do Not Resterilize Other Medical Device Related Standards 5
K ISO 15223-1 Sterile barrier system - The 3-layer symbol EU Medical Device Regulations 1
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
ernieto 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
R Is BS EN ISO 15223-1 a harmonised standard? EU Medical Device Regulations 2
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
chris1price Archiving of paper records - ISO 9001 7.5.3.1b Records and Data - Quality, Legal and Other Evidence 4
M Transferring ISO 17025 from one company to another ISO 17025 related Discussions 1
D Common practices in ISO 9001 deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
B ISO 17025:2017 risk management Risk Management Principles and Generic Guidelines 0
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO 2768-mk print call out Other ISO and International Standards and European Regulations 11
T ISO 17024, clauses 4.3.8. and 5.1.1. Other ISO and International Standards and European Regulations 4
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
John C. Abnet ISO 26262 ISO 26262 - Road vehicles – Functional safety 3
Marc ISO 26262- Road vehicles – Functional safety ISO 26262 - Road vehicles – Functional safety 0
John C. Abnet ISO 26262 IATF 16949 - Automotive Quality Systems Standard 0
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
K PDCA cycle and ISO processes alternative model Quality Management System (QMS) Manuals 14
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
D Which ISO Standard to purchase? ISO 13485:2016 - Medical Device Quality Management Systems 7
V ISO 10360-5: 2020 Gap analysis and Action plan Excel .xls Spreadsheet Templates and Tools 1
Q ISO 9001 - Reseller Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
C ISO 45001 6.1.2.1 Hazard Identification Occupational Health & Safety Management Standards 1
T The difference between ISO 14644-3:2005 and ISO 14644:2019 Other Medical Device Related Standards 2

Similar threads

Top Bottom