Standards and Copyrights wrt citing them in Procedures

v9991

Trusted Information Resource
#1
is it within legal/regulatory laws to cite the contents of the 'standards' in procedures, even if we have not purchased them, nor have a written permission for same.

some citations could be as simple as definitions, others, it could be detailed acceptance sampling table or lot acceptance criteria!!!

we often get the snippets, excerpts of the standards in certain articles, drafts or white papers on the internet. (which are free for access/download)
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
Ed Panek MDR Harmonized Standards Updated EU Medical Device Regulations 1
B Calibration of Thread Gages with Metric Standards with Conversion to Imperial Units General Measurement Device and Calibration Topics 3
E Sources of every single paragraph of the ISO 9001 standards? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
E Do I need test reports for all standards mentioned in my 510k application? Other Medical Device Related Standards 8
Q Harmonised Standards (EN ISO 13485 / EN ISO 14971) in MDR (2017/745/EU) ISO 13485:2016 - Medical Device Quality Management Systems 3
placebo_master How to comprehend the paragraph architecture of OSHA standards in 1910 Subpart S Occupational Health & Safety Management Standards 6
K MHLW MO169 2021 Japan Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics Japan Medical Device Regulations 2
M Periodically verifying revision levels of published standards Other ISO and International Standards and European Regulations 4
S Which ISO Standards to Purchase - EN ISO and/or ISO Other Medical Device Related Standards 1
D Customer requirements on specific standards Various Other Specifications, Standards, and related Requirements 6
M Does 4.5 - Alternative RISK CONTROL apply to the Particular Standards? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
N How to validate Regulations and Standards? ISO 13485:2016 - Medical Device Quality Management Systems 12
E Comparison of Personal Protective Equipment Standards EN 14605 vs GB24539 and ISO 13982 vs GB 24539 Occupational Health & Safety Management Standards 0
E Comparison of Respiratory Protective Equipment Standards (China Standard Compare with EU standard of EN149 Occupational Health & Safety Management Standards 2
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Special Controls and Standards Other US Medical Device Regulations 0
A Industry Standards for Cosmetic Inspection Criteria Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
G How to record Regulations and Standards as Design Inputs? Design and Development of Products and Processes 15
Ed Panek External Standards List - Should this document include previously revised standards? ISO 13485:2016 - Medical Device Quality Management Systems 4
S MDR GSPR Standards EU Medical Device Regulations 1
S Class 1 and 2 changes in CM standards (aerospace industry) Federal Aviation Administration (FAA) Standards and Requirements 0
S 316 Stainless Steel Standards Other Medical Device Related Standards 3
U Is there any website out there that summarizes all relevant standards? Medical Device and FDA Regulations and Standards News 1
M Packaging standards - ASTM vs ISTA Other Medical Device Related Standards 1
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 5
M Why are EU harmonized particular standards so old & out-of-date? IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
R Weld Penetration Standards and Requirements Manufacturing and Related Processes 2
S Any ISO standards around Artificial Intelligence and Machine Learning? Medical Information Technology, Medical Software and Health Informatics 4
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
M MDR harmonized standards EU Medical Device Regulations 7
S Where do l get calibration standards to run a calibration lab? Other ISO and International Standards and European Regulations 2
C Appendix Z in Harmonised Standards? EU Medical Device Regulations 15
Ajit Basrur Corporate management standards ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Revision36 Engineering Change Order Industry Standards Other Medical Device and Orthopedic Related Topics 6
R Applicable ISO standards - packaging and others Medical Device and FDA Regulations and Standards News 4
Q Standards for Shipping by Sea US Food and Drug Administration (FDA) 2
N Database that lists labs accredited to ASTM / ANSI standards Various Other Specifications, Standards, and related Requirements 6
SANTHSH API Spec.Q1 Standards Version in Purchasing Information Oil and Gas Industry Standards and Regulations 1
B Exclusions or justification for non-applicability of IEC standards Reliability Analysis - Predictions, Testing and Standards 1
P Citing EN standards Other Medical Device Related Standards 6
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3
N Harmonized Standards for MDR Certification EU Medical Device Regulations 7
A Some questions about voluntary consensus standards in traditional 510(k) submission US Food and Drug Administration (FDA) 6
D Imaging/Image Quality Standards Other Medical Device Related Standards 1
R ECG Risk Analysis Standards ISO 14971 - Medical Device Risk Management 2
I Management review in conformity assessment standards - Certification Bodies Management Review Meetings and related Processes 6
Govind Informational ISO COVID-19 response: freely available ISO standards Other ISO and International Standards and European Regulations 1
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4
T Assessing Hazard-Related Use Scenarios where control measures exist through standards IEC 62366 - Medical Device Usability Engineering 32
Richard Regalado Informational ISO makes available relevant BCMS standards free for online access Business Continuity & Resiliency Planning (BCRP) 6
Al Rosen Technical File - Updating Applied Standards EU Medical Device Regulations 4

Similar threads

Top Bottom