Urine Analyzer standard besides the IVD standard (98-79-EEC)?

L

lqk980

#1
Dear All,
Now our Company is develop the urine analyzer - Is there a special standard applicable for Urine Analyzer besides the IVD standard (98-79-EEC)?
Thanks very much for your warmly replay:applause:
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
A quick "Bump" - If anyone here can help with this one, my Thanks in advance!
 

bio_subbu

Super Moderator
#3
Dear All,
Now our Company is develop the urine analyzer - Is there a special standard applicable for Urine Analyzer besides the IVD standard (98-79-EEC)?
Thanks very much for your warmly replay:applause:
Hi

Welcome to the Cove!!

I would like to correct you that IVDD 98/79/EEC is not a standard, it’s a regulation (Directive). Apart from said directive, I request you to go through the applicable European Commission guidelines (MEDDEV). This guidelines aim at promoting a common approach by manufacturers and Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the aforesaid Directive, and by the Competent Authorities charged with safeguarding Public Health.

To download the guidelines, please refer below European commission website

Please be patient, someone will help you as regards to product (Urine Analyzer) specific standards (list of applicable standards)

Regards
S.Subramaniam
 
L

lqk980

#4
Hi Subbu,
Thank you very much! I am fresh here and is my honor to get advice from you, I am also fresh in the IVD industry field. Now I on a deeper understanding of the EEC Directive.

Best Regards
QK
 
Thread starter Similar threads Forum Replies Date
Marc Urine Spills Staining Image of Wockhardt?s Generic Drugs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
B Urine Reagent Strips - Which directive should I put on the declaration? EU Medical Device Regulations 1
H Calibration of InfraRan Vapor Analyzer - where to get calibration for SF6 General Measurement Device and Calibration Topics 2
M Raw stock material testing discrepancy using an XRF (x-ray fluorescence) analyzer Manufacturing and Related Processes 7
M Normalizing a Spectrum Analyzer General Measurement Device and Calibration Topics 6
P How do you calibrate a VNA (Vector Network Analyzer) cal kit? General Measurement Device and Calibration Topics 4
A Accuracy for electrosurgical analyzer General Measurement Device and Calibration Topics 2
A Accuracy Calculation of Leakage Current for an Electrical Safety Analyzer General Measurement Device and Calibration Topics 5
A Intrinsic Uncertainty and Accuracy of a Medical Electrical Safety Analyzer General Measurement Device and Calibration Topics 1
Q Need help on MSA study on a torque analyzer Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
N Moisture Analyzer Out of Calibration - Easy Way to Confirm Everything Ok? General Measurement Device and Calibration Topics 3
N The Best Moisture Analyzer for Plastics General Measurement Device and Calibration Topics 6
F Moisture Analyzer Calibration Reference Standard General Measurement Device and Calibration Topics 7
G Is Agilent?s automated network analyzer verification ISO/IEC-17025 compliant? ISO 17025 related Discussions 4
J 3-D Surface Analyzer Service (Zygo) - Third Party Maintenance and Calibration General Measurement Device and Calibration Topics 5
5 Do you know a portable hydraulic oil analyzer? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
M Calibration of Cable & Antenna Tester: Site Analyzer General Measurement Device and Calibration Topics 8
D Has anyone had experience with a Portable XRF Analyzer? General Measurement Device and Calibration Topics 4
A Integrity of Flue gas analyzer? General Measurement Device and Calibration Topics 5
A Need to send out for Calibration or Self-calibration? HP model# 35670A analyzer General Measurement Device and Calibration Topics 4
D Valid study for CO samples both Analyzer and Drager Tube results? Statistical Analysis Tools, Techniques and SPC 1
A Is there a standard on tolerances of substances ? Medical Device and FDA Regulations and Standards News 0
P Pooled Standard Error - Minitab Statistical Analysis Tools, Techniques and SPC 0
SABRINA DJILALI SAIAH Implementation of the ISAS-MEDIA 9001 standard in a TV channel ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
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
B European Harmonized vs IEC standard IEC 62366 - Medical Device Usability Engineering 2
Moumen H Variations between ASTM A29 Standard for steel bars and Mill test certificates specs Manufacturing and Related Processes 1
D Which ISO Standard to purchase? ISO 13485:2016 - Medical Device Quality Management Systems 7
K IEC 60601-1:2005/AMD2:2020, Why this standard version is 3.0? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C Standard -Machinist Handbook Customer Complaints 4
N EN 813, EN 12277, EN 1497 - Testing some harness prototypes to an EN standard Various Other Specifications, Standards, and related Requirements 0
R Remote Audits for ISO 9001 (or any other standard) General Auditing Discussions 31
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
Y Auditory alarm standard IEC 60601-1-8 Reliability Analysis - Predictions, Testing and Standards 0
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
S Shore A hardness Tester Acceptance Criteria Standard Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 2
Sidney Vianna What ISO Standard (under the TC 176) supports the UN Sustainable Development Goal #10? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 11
John Broomfield Vote - Should ISO9004 Become a Requirements Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
J SAE J1739 standard IATF 16949 - Automotive Quality Systems Standard 2
Marcel DS LV 123 - BMW, AUDI, Mercedes Standard VDA Standards - Germany's Automotive Standards 1
F Standard Calibration Procedures: Recommended Practice ISO 17025 related Discussions 0
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
Y UL 1998 Standard: software classes Software Quality Assurance 0
G What to do with correction factors overlooked by an accredited standard (6.4.11)? ISO 17025 related Discussions 5
G Copy of withdrawn ISO 9001:1994 Quality Management Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Anonymous16-2 SOP (Standard Operating Procedure) Numbering Document Control Systems, Procedures, Forms and Templates 7
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3
Skooma Deburring and Tolerances - Is there a Standard for deburring or removing material? Manufacturing and Related Processes 3
B Purchasing AS9100D Standard in Japanese AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2

Similar threads

Top Bottom