EN 1041 or EN 980 - Need Documents Please!

T

Tara Burrell

#1
:read:

Hello Elsmar! This will be my first post....

I am the only member in my companies Quality Team with only one year of experience, with NO previous experience prior to this job. I visit this forum frequently and appriciate the info.

My question is: Does anyone have a copy of EN 1041 or EN 980 that you would be will to share with me? I am creating technical files for our products, and would like to have these requlations due to the fact that we ONLY sell internationally and a lot of our business is in the EU. I would appricate any help, website direction, copies, etc.... of anything that will help me master this ENORMOUS task!

Thank you!
Tara
 
Elsmar Forum Sponsor
S

SteveK

#3
As will be pointed out - there is a copyright issue here. You have to buy them! Join e.g. BSI and get them a half price (if you are going to buy a number of standards in the future).
 
Thread starter Similar threads Forum Replies Date
I BS EN 1041 - BS EN 980 - BS EN ISO 14630 revisions - What are the changes Other Medical Device Related Standards 4
M Is Harmonised EN 1041 (Information Supplied By Manufacturer) Worth Looking At? EU Medical Device Regulations 7
J Sterile Medical Device Labeling Requirments - ISO 1041 Other Medical Device and Orthopedic Related Topics 1
G What are the changes in the BS EN 1041:2008 recently published amendment Other Medical Device Related Standards 11
V External Standards - EN 1041 - Medical Devices Book, Video, Blog and Web Site Reviews and Recommendations 3
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
B Was EN 980:2008 superseded by EN 15223-1:2012 on January 31, 2013 CE Marking (Conformité Européene) / CB Scheme 2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
L Medical Device Labeling Requirements - EN:980:2008 Other Medical Device Regulations World-Wide 2
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
C Where can I download the EN 980:2008 Medical Device IFU Symbols? Other Medical Device Related Standards 16
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
J EN 980:2008(E) - Graphical Symbols for Labeling Medical Devices ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
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
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
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 0
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
J Need a contract monitoring Tool General Information Resources 0
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 0
J Need Help with FPY Data in Assembly Process Manufacturing and Related Processes 7
W 17025 and NIST handbook relationship (need advice) ISO 17025 related Discussions 8
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
K Need procedure for D&D inputs? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Need help on "Country of Origin" Medical Device and FDA Regulations and Standards News 0
Ed Panek Immediate need for 80601-2-56 Consulting expert. PM me for details Career and Occupation Discussions 0
Tagin You're Gonna Need a Bigger Root Cause Coffee Break and Water Cooler Discussions 12
M PSA Suppliers - CSR matrix and need the quality manual of PSA APQP and PPAP 2
M Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
K "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
I Do I need to sign off my annual audit calendar? Internal Auditing 2
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
M Do I need separation in my circuit with a medical charger? IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
V Certified Auditor - Need of additional certification specific to industry ( GMPs) ASQ vs ECA vs others Professional Certifications and Degrees 1
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3
K Do I need a "State of the art" plan? CE Marking (Conformité Européene) / CB Scheme 1
S Need advice for schooling Quality Manager and Management Related Issues 5
R What information do i need to get from the device manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Need guidance on project ISO 13485:2016 - Medical Device Quality Management Systems 2
H Need MSA 4th ed. compliant attribute MSA template General Measurement Device and Calibration Topics 4

Similar threads

Top Bottom