Horizontal and Vertical Standards - Definitions in EU Technical File - ER checklist

E

Ethan Loh

#1
Hi can anybody teach me what is the differences between horizontal and vertical standards in EU technical file ER checklist ?
 
Elsmar Forum Sponsor

rob73

looking for answers
#2
Re: What is horizontal and vertical standards in EU technical File - ER checklist?

Ethan
A quick google search gave this from the Molnycke web site

"For the purposes of EU medical device regulation, standards are essentially divided into "horizontal" and "vertical" standards. Horizontal standards are those that apply equally to all medical devices.

Examples are EN46001 and EN46002 for quality management in manufacturing, EN30993 for biocompatibility, EN552 for sterilisation, and EN980 for symbols. Vertical standards apply to specific products or product groups. Examples are EN600 for condoms and EN455 for medical gloves"

Cheers and a happy Christmas
Rob
 
Thread starter Similar threads Forum Replies Date
O Air Flow - Which is the operational difference between LAF (vertical and horizontal) and RLAF? Manufacturing and Related Processes 2
J Datum B and C are each both vertical and horizontal - Tolerance of Position Question Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
L Process Maps - Change from Vertical to Horizontal Swimlanes - Visio Process Maps, Process Mapping and Turtle Diagrams 3
L Vertical vs Horizontal Integration ISO9000 QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M ISO 17025 Audit check list to conduct horizontal and vertical audits ISO 17025 related Discussions 10
S GR&R for an "R" value instrument installed on my 10K Horizontal Tester Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
V Horizontal Boring Machine Calibration General Measurement Device and Calibration Topics 7
kedarg6500 Horizontal Deployment of Corrective Action - is it Preventive Action? Nonconformance and Corrective Action 21
R ISO 17025 vertical audit checklist wanted Document Control Systems, Procedures, Forms and Templates 2
R Vertical Supplier Audit Plan Supplier Quality Assurance and other Supplier Issues 4
G Testing and Validating a New Vertical Milling Machine AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
E Oscilloscope Measurement Uncertainties - MU Components for Vertical Deflection Measurement Uncertainty (MU) 3
B SMED in a vertical CNC Lathe Workstation consisting of 3 similar machines Lean in Manufacturing and Service Industries 2
B Laboratory Vertical Audit advice and information needed General Auditing Discussions 1
D Clipboards (vertical) for Chemical Laboratory? General Measurement Device and Calibration Topics 1
I How to add a vertical reference line in my excel .xls bar graph Excel .xls Spreadsheet Templates and Tools 9
M Packaging standards - ASTM vs ISTA Other Medical Device Related Standards 0
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 10
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 3
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 13
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 4
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
S 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
A Technical File - Updating Applied Standards EU Medical Device Regulations 4
A NB (Notified Body) Audit of Standards ISO 13485:2016 - Medical Device Quality Management Systems 3
R Applicability of new non-harmonized standards (MDD/MDR) EU Medical Device Regulations 14
dgrainger Informational EU published new Harmonised Standards List for the Directives (25/3/2020) Medical Device and FDA Regulations and Standards News 0
P Static Electricity/Pacemaker - Standards for static electricity generation CE Marking (Conformité Européene) / CB Scheme 3
M Referencing Harmonised Standards in Declarations of Conformity EU Medical Device Regulations 4
Pmarszal External Standards and Regulations Management Process Document Control Systems, Procedures, Forms and Templates 10

Similar threads

Top Bottom