X-ray's light testing - What is the standard to test the X-ray light brightness?

Elsmar Forum Sponsor
T

Tiffany

#3
Re: X-ray's light testing

Thanks Mates!

What is the ISO/ IEC standards that need to comply or refer to?

Tiff...
 
M

MIREGMGR

#4
Re: X-ray's light testing

Is this inquiry about scanning electron microscopes (SEMs)? The posted link provides calibration resources for SEMs.

If the question instead was about medical-diagnostic Xray equipment, are calibration instruments for SEMs considered acceptable for medical-equipment calibration? The technology is very different, and I'm under the impression that the instrument-calibration-chain requirements for medical calibration are rigorous.

It would help if the original poster could more fully explain what equipment and application they're asking about.
 
T

Tiffany

#8
hI mateS,

Oops... misleading information given! ...

actually I am looking for the testing relevant to X-ray scanner's light testing BUT NOT the X-ray radiation. Is there any testing or specification for that light as specified in any national or international requirements?

Anyone there can help me??

looking forward.....

:thanx:
Tiffany ;0)
 
M

MIREGMGR

#10
Regarding national requirements in the US market...FDA 21 CFR 1020.31(d)(2) says:

(ii) When a light localizer is used to define the x-ray field, it shall provide an average illuminance of not less than 160 lux (15 footcandles) at 100 cm or at the maximum SID, whichever is less. The average illuminance shall be based on measurements made in the approximate center of each quadrant of the light field. Radiation therapy simulation systems are exempt from this requirement.
(iii) The edge of the light field at 100 cm or at the maximum SID, whichever is less, shall have a contrast ratio, corrected for ambient lighting, of not less than 4 in the case of beam-limiting devices designed for use on stationary equipment, and a contrast ratio of not less than 3 in the case of beam-limiting devices designed for use on mobile and portable equipment. The contrast ratio is defined as I1/I2, where I1 is the illuminance 3 mm from the edge of the light field toward the center of the field; and I2 is the illuminance 3 mm from the edge of the light field away from the center of the field. Compliance shall be determined with a measuring aperture of 1 mm.
Measurement of illuminance in lux or footcandles is a mature technology for which techniques are standardized, measurement laboratory service providers are broadly available, and laboratory instruments and corresponding calibration services are readily available.

As far as I know, the FDA has no other guidance or regulation specifically addressing guide lights. I think Form 3627 is in effect the report form for a product filing to demonstrate compliance with 21 CFR 1020.31 per above.
 
Thread starter Similar threads Forum Replies Date
D X-Ray sterilisation plants in the UK? Other Medical Device and Orthopedic Related Topics 3
B X-Ray Sensor Device Symbols for IFU Medical Device and FDA Regulations and Standards News 1
C Gamma to X-Ray Transition Other Medical Device Related Standards 12
L How to deal with the model number symbol for X-RAY PRODUCT Other Medical Device Related Standards 1
K Guidance on X-Ray Medical Devices for Animal Use - FDA US Food and Drug Administration (FDA) 0
B Process / Procedure - Radiographic (X-Ray) Non-Film Document Control Systems, Procedures, Forms and Templates 0
R X-RAY Based Diagnostic Veterinary medical Devices Medical Device and FDA Regulations and Standards News 2
K Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 7
R Expected life span of Medical devices - X-Ray based diagnostic medical devices ISO 13485:2016 - Medical Device Quality Management Systems 6
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, NADCAP and Aerospace related 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
W X-ray based NDT Test Equip. Mfger. seeking CE Mark - Must X-Ray Source be included? CE Marking (Conformité Européene) / CB Scheme 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
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

Similar threads

Top Bottom