X-ray based NDT Test Equip. Mfger. seeking CE Mark - Must X-Ray Source be included?

W

w_grunfeld

#1
A manufacturer of X-ray based NDT test equipment is seeking CE mark for the tester. The tester can work with different X- ray generators which are purchased by users separately, in fact requires different types of sources as a function of the inspected item.
Based on the above arguments , the manufacturer would like to exclude the X-ray source from the CE conformity assessment/testing. My advice to him is that he cannot do this as the tester cannot perform its intended function without an X source. I also think that if different sources are required for different item types to be inspected by the test equipment, it needs to be assessed /tested with each. Any thoughts on this?
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Re: X-ray based NDT Test Equip. Mfger. seeking CE Mark - Must X-Ray Source be include

A Quick Bump!

Can someone help Willy?

Thank you very much!!
 

Mikishots

Trusted Information Resource
#3
Re: X-ray based NDT Test Equip. Mfger. seeking CE Mark - Must X-Ray Source be include

A manufacturer of X-ray based NDT test equipment is seeking CE mark for the tester. The tester can work with different X- ray generators which are purchased by users separately, in fact requires different types of sources as a function of the inspected item.
Based on the above arguments , the manufacturer would like to exclude the X-ray source from the CE conformity assessment/testing. My advice to him is that he cannot do this as the tester cannot perform its intended function without an X source. I also think that if different sources are required for different item types to be inspected by the test equipment, it needs to be assessed /tested with each. Any thoughts on this?
If those purchasable generators are not the ones specified by the manufacturer, the device as a whole does not comply with the CE directive.

If a product is sold that has a design feature that allows peripheral or optional parts, the CE mark is intended to apply to the product with each of those parts. The source cannot be excluded from the technical package.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: X-ray based NDT Test Equip. Mfger. seeking CE Mark - Must X-Ray Source be include

Have all applicable EC Directives, Regulations, Decisions etc. been identified? Typically, the governing directive would have the definitions and requirements to answer such questions, right in the first few articles.

In general I tend to agree that the CE marking relates to product use together with any specified accessories (= elements required for allowing it to achieve its designated goal).
 
W

w_grunfeld

#5
Re: X-ray based NDT Test Equip. Mfger. seeking CE Mark - Must X-Ray Source be include

Ronen,
The governing Directive is the LVD- I didn't find in it any hint.
Willy
 

CharlieUK

Quite Involved in Discussions
#6
Re: X-ray based NDT Test Equip. Mfger. seeking CE Mark - Must X-Ray Source be include

I would imagine that you will also be considering the EMC directive.

You should consider how using different sources might affect the safety or EMC performance of you device.
You should ensure that your product can be used whilst adhering to typical safety/handling/operating requirements for X-ray sources (I don't know what these are)
 
Thread starter Similar threads Forum Replies Date
R Expected life span of Medical devices - X-Ray based diagnostic medical devices ISO 13485:2016 - Medical Device Quality Management Systems 6
K Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 5
M Informational MHRA Guidance – Dental radiographic X-ray imaging: dose to patients Medical Device and FDA Regulations and Standards News 0
M Raw stock material testing discrepancy using an XRF (x-ray fluorescence) analyzer Manufacturing and Related Processes 7
M Informational US FDA Medical X-ray Imaging Devices guidances Medical Device and FDA Regulations and Standards News 0
JoshuaFroud Import of X-Ray emitting device into Chile Other Medical Device Regulations World-Wide 0
K Is Compliance Testing of IEC 60601-2-63 mandatory for Europe - Dental X-Ray machine CE Marking (Conformité Européene) / CB Scheme 3
K Post Market Clinical Follow up and CE Marking for Class IIb medical X-Ray products CE Marking (Conformité Européene) / CB Scheme 1
K Calibration of Dose Area Product (DAP) Meter in our Class IIb X-Ray Medical Device General Measurement Device and Calibration Topics 1
M AS9100D Competence and Training Records - X-Ray AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
M FDA News USFDA Draft Guidance – Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment Medical Device and FDA Regulations and Standards News 0
R Software validation - off the shelf X-Ray Software Quality Assurance 3
J Looking for Testing facility to do testing of x ray sensors for us US Food and Drug Administration (FDA) 1
P MSA on an in-line automatic X-ray thickness measuring gage Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
U MRI, CT and X-ray deleted from the EUOJ standards list of May 16, 2014 EU Medical Device Regulations 1
E INDONESIA: Regulatory Requirements for Veterinary x-ray equipment Other Medical Device Regulations World-Wide 2
Y Labeling requirements for X-ray detector Other US Medical Device Regulations 1
M Clinical Evaluation sample for X-Ray Machine CE Marking (Conformité Européene) / CB Scheme 1
A CE marking for a X-ray Imaging Detector CE Marking (Conformité Européene) / CB Scheme 5
Q Gage R&R on X-Ray Fluorescence (XRF) Equipment Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
Marc Ray Harryhausen - The Stop Motion Animation King Coffee Break and Water Cooler Discussions 4
T ISO9001 book - Ray Tricker or David Hoyle? Book, Video, Blog and Web Site Reviews and Recommendations 5
T X-Ray Template Medical Device Classification (US) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Marc Ray Bradbury of "Fahrenheit 451" fame - RIP - June 5th, 2012 World News 4
Ronen E FDA distributes draft guidance related to X-ray Imaging Device 510(k)s Other US Medical Device Regulations 1
K X-Ray Fluorescent (XRF) Test - Definition Misc. Quality Assurance and Business Systems Related Topics 6
A Need help with a Kappa Study (MSA) - Reviewing x-ray Images Six Sigma 11
K Gamma Ray Sterilization Quarterly Dose Auditing Supplier Requirements ISO 13485:2016 - Medical Device Quality Management Systems 5
B Refurbisher (re-loader) of OEM X-Ray Tubes - Marketing to Canada ISO 13485:2016 - Medical Device Quality Management Systems 1
I Choosing a X-Ray Fluorescence Measuring Device for Chrome Coating Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
R What is the Device Classification for X-ray template in Europe ? EU Medical Device Regulations 9
S Registration Requirements for X-ray & Oncology Product in Russia Other Medical Device Regulations World-Wide 4
C X-Ray Producing Product Regulations in Mexico, Central America, and South America Other Medical Device Regulations World-Wide 2
A Software requirements and X-ray devices Other Medical Device Related Standards 5
Q Validation of X-RAY Process used in detecting voids in castings Qualification and Validation (including 21 CFR Part 11) 9
T X-ray's light testing - What is the standard to test the X-ray light brightness? ISO 13485:2016 - Medical Device Quality Management Systems 9
M IEC 60601-1-3 2nd Edition (X-ray Radiation Protection) IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D Tips/Documentation samples required for X-ray Film Processor Installation needed. ISO 13485:2016 - Medical Device Quality Management Systems 1
I X-Ray Films - CE-Mark and Related Standards Requirements ISO 13485:2016 - Medical Device Quality Management Systems 3
A X-Ray for Dimensional Inspection and Scanning for Defects within Polyurethane Foam Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
Marc Thinking of Vista OS from Microsoft? Will it play HD-DVDs or Blu-ray? After Work and Weekend Discussion Topics 2
R Bone Cement and Contrast Medium for X-Ray Purpose - A Combined Product? ISO 13485:2016 - Medical Device Quality Management Systems 6
B X-Ray / Scanning systems - Material - Celcon M90, 2-3mm thick General Measurement Device and Calibration Topics 3
C Is X-Ray Data Variable or Attribute? How to do a capability study? Statistical Analysis Tools, Techniques and SPC 3
Marc Next generation of DVDs - Blu-Ray vs. HD DVD format After Work and Weekend Discussion Topics 0
B How to classify a medical device based on MDR? EU Medical Device Regulations 3
I How to classify a medical device based on FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D Tolerance definition based on expected Cp/cpk Reliability Analysis - Predictions, Testing and Standards 13
S Risk based internal auditing Internal Auditing 6
G Any good examples of CAPA forms that include a risk based approach? ISO 13485:2016 - Medical Device Quality Management Systems 5
Similar threads


















































Top Bottom