What is the applicable standard for Chair Mounted Dental Unit for CE

W

william_N

#1
Hello all,
Does anyone know the applicable standard for this product to get CE mark?
some information see below:
▲Main unit
Control panels on both dentist and assistant sides
4-hole instrument hose 3pcs
3-way syringe 2pc
Intra X-ray film viewer 1pc
Rotatable ceramic cuspidor
Rotatable assistant holder
Clean water system
Water heater system
Saliva ejector 1pc
Air suction (with filter) 1pc
Operating light & arm (D200YA) 1pc
Foot controller 1pc
▲Patient chair
FJ94 chair
Complete electric dental chair
24V safety low voltage motor driven
Pre-Programmable position for all function
Left armrest 1set
Right armrest 1set
Seamless upholstery
Joystick foot controller 2sets
Headrest for adult and children
▲Basic package including
Main unit 1set
Patient chair (FJ94) 1set
Dental stool (FJ108) 1set
Dimensions (mm):1440*1130*1130

Thanks
 

Attachments

Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
You don't "get a CE mark". You comply with all the applicable requirements of the Medical Devices Directive (93/42/EEC), and all other applicable EC directive that provide for CE marking, and then you apply the CE mark.

Typically, there's no single standard that will guarantee such compliance. You can make use of harmonized standards (see the MDD article 5) but there's more to it.

If you are unfamiliar with the MDD and/or the EC "new approach" scheme then I recommend you start off with some reading, or hire a consultant to walk you through.

Cheers,
Ronen.
 

mehrnaz

Starting to get Involved
#3
I have a question regarding dental unit and dental chairs. Is the combination of them a ME system according clause 16 of IEC 60601-1?
 
Thread starter Similar threads Forum Replies Date
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
D Control chart applicable? Percentage of compliance with a standard Statistical Analysis Tools, Techniques and SPC 2
P Is Internal and external audit of Account Department applicable to any ISO standard Internal Auditing 5
M Who has the final say on which subclauses are applicable from a given standard? EU Medical Device Regulations 1
C AS9100, ISO Standard Applicable to Lighting for Workstations and Inspection Stations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
C Device 'A' has no applicable Standard, but a very similar product 'B' does Other Medical Device Related Standards 6
D FMEA with 2 or 3 criteria? Standard applicable to the Medical Device industry ISO 14971 - Medical Device Risk Management 13
Q ISO 9001 vs. TL9000 - Which standard is more applicable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N Which standard is applicable for IR LED in conjunction with medical devices? Other Medical Device Related Standards 5
Raffy ISO22000:2005 Food Safety Management System - Applicable Internal Audit standard? General Auditing Discussions 7
J Are complaints applicable to development of medical devices? Customer Complaints 2
Z Is Op Amp Common-Mode Rejection Ratio (CMRR) test applicable to battery operated devices? Other Medical Device Related Standards 0
R Applicable ISO standards - packaging and others Medical Device and FDA Regulations and Standards News 4
M Change management procedure when 7.3 is not applicable ISO 13485:2016 - Medical Device Quality Management Systems 5
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Machine directory (2006/42/EEC) is applicable or not Other Medical Device Related Standards 0
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4
R An indication that the device is a medical device (MDR, Annex 23.2q) - applicable for accessories? EU Medical Device Regulations 5
N Is capability applicable for a destructive test? Capability, Accuracy and Stability - Processes, Machines, etc. 9
DuncanGibbons Are the IQ OQ & PQ procedures applicable to the aerospace industry? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
G App - Local regulations applicable EU Medical Device Regulations 2
M Do you need an Applicable general safety and performance requirements Checklist? EU Medical Device Regulations 2
S SOPs applicable for Regulatory Affairs department Other ISO and International Standards and European Regulations 1
DuncanGibbons Who are ISO/IEC 17065 and 17025 applicable to? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
G Is impact test according to IEC 60601-1 applicable for HAND-HELD equipment if also classified as BODY-WORN? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B EU MDR Quality System Requirements - Applicable to Class I? EU Medical Device Regulations 5
R CQI-15 for ultrasonic welding splices on wiring harness, is applicable? Customer and Company Specific Requirements 3
C Is IEC 60601 applicable to our smart bed? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
D Applicable MDR Annex's for Class IIa Medical Devices EU Medical Device Regulations 0
M Dilemma about choosing the most applicable clause related to Risk ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
DuncanGibbons To what extent are NASA standards applicable to commercial aviation? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
B Does EMC Directive 2014/30/EU cease to apply when the Machine Directive 2006/42/EC is applicable? CE Marking (Conformité Européene) / CB Scheme 4
M Accelerated Ageing Test for Orthopedic Implants -- ASTM F 1980 or ISO 11607 or both are applicable ? Other Medical Device and Orthopedic Related Topics 2
Z CQI-15 Welding System Assessment - Robotic Ultrasonic Foam onto Plastic "Weld" applicable? Various Other Specifications, Standards, and related Requirements 3
M CEP requirements in MEDDEV 2.7/1, rev 4 and MDR - Are all MEDDEV requirements still applicable? EU Medical Device Regulations 7
MrTetris GDPR - General Data Protection Regulation - Only applicable to EU data? Other ISO and International Standards and European Regulations 6
qualprod Only manufacturing, non applicable - ISO 9001 Clause 8.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
K Assigning the Correct Procedures Applicable to Job Titles General Auditing Discussions 15
L Pneumatic powertool (Drill) - Is IEC 60601-1 applicable? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Q Applicable Medical Device Wifi regulations for various Countries Other Medical Device Regulations World-Wide 7
pcoltsqe AS9100 - The statement 'applicable statutory and regulatory requirements' AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
qualprod Is it a NC, if a clause is not declared as non applicable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A ISO 13485:2016 Applicable regulatory requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
R ISO 9001:2015 Clause 7.1.5.2 - Is Measurement traceability applicable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
T To Identify the Applicable MDD Directive - Prepared blood smear EU Medical Device Regulations 13
qualprod Non applicable clauses in a reseller? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N Class I 510(k) exempt - Applicable Standards 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T IATF16949:2016 8.7.1.4 Control of non-applicable reworked product IATF 16949 - Automotive Quality Systems Standard 3
B Standards Needed In House - Determining what standards are applicable Various Other Specifications, Standards, and related Requirements 3
M ISO13485:2016 - Exemption vs. Not Applicable ISO 13485:2016 - Medical Device Quality Management Systems 16

Similar threads

Top Bottom