CISPR 11 - Assessment of Conformity

B

b_malone

Hello All,

Need a little assistance... I have been reading CISPR 11 Clause 12 specifically around the sampling to determine 80/80 for serial manufactured devices.

Should Clause 12 be followed to ultimately determine conformity to the standard? I am assuming yes...

Has anyone performed the statistical analysis identified by CISPR 11? If so how did you go about doing it. I came across CISPR 16-4-3 that described in more detail on how to do it, just wondering if anyone has used that as well.

I appreciate any guidance anyone can provide.

thank you
 
B

b_malone

Hi Pads38 thanks for taking the time to respond. Yes I saw that response when I first started looking into this...it doesn't quite answer what I am looking for.

We defined our medical equipment manufacturing process as serial so we need to follow the statistical assessment identified by clause 12 to demonstrate that our manufacturing method will be able to produce equipment with 80% confidence that 80% of the equipment will comply with the limits (80/80).

The problem we are having is it isn't very clear on how the analysis should be done. CISPR 16-4-3 is a technical report that provides guidance on how to do statistical analysis...just wondering if others did the same

...does your test house ask about your manufacturing method? just asking because i am curious if they apply Clause 12 when it comes determining compliance
 
P

Pads38

Moderator
In answer to your question - no our test house does not ask about our manufacturing methods.

Quite often we will put in "fixes" at the test house - things like added ferrites, extra earth bonding etc. - when that happens we work with the test house to make sure that the "fix" is something that is straightforward to implement in production.

So all our tests have been a single representative sample only.

There is another thread where this has been discussed here:
http://elsmar.com/Forums/showthread.php?t=67656

I believe that the situation is the same - all of the 60601 series are based on a type test of a representative sample of production.

I suppose that manufacturing variability is something that you may have to address in your risk management process.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
J Confusing on Harmonic Emissions/Voltage Fluctuations/Flicker test for CISPR 11 Class A Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N The formal definition of Domestic Environments in in CISPR 11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A Difference between CISPR 11 and BS EN 55011 Other ISO and International Standards and European Regulations 2
E List of Complete EMC Test Requirements consisting of IEC, EN, Cispr, etc. General Measurement Device and Calibration Topics 2
T IVD Self-Test Notified Body Conformity Assessment Process EU Medical Device Regulations 0
John Broomfield The Common Assessment Standard (prequalifying construction suppliers to bid) Misc. Quality Assurance and Business Systems Related Topics 0
Y Gap assessment comparing RDC ANVISA 665/2022 and RDC ANVISA 16/2013? Other Medical Device Related Standards 0
A Risk Assessment for ISO 13485:2016 section 7?? ISO 13485:2016 - Medical Device Quality Management Systems 11
GreatNate Looking for Hazardous Material Management Plan example or HMMP assessment checklist Occupational Health & Safety Management Standards 6
Q External providers assessment - ISO 14001 ISO 14001:2015 Specific Discussions 4
L CQI-30 Special Process: Rubber Processing System Assessment - Mixing & Molding IATF 16949 - Automotive Quality Systems Standard 4
D Conformity Assessment for a System Class IIb EU Medical Device Regulations 0
M Safety assessment of cosmetic product EU Medical Device Regulations 1
J Conformity assessment route options under the UK MDR 2002 (2002 SI No. 618), as amended UK Medical Device Regulations 1
FuzzyD ISO 13485:2016 Customer Assessment OFI ISO 13485:2016 - Medical Device Quality Management Systems 2
M Regulatory Change assessment US Food and Drug Administration (FDA) 3
Q Product audit assessment IATF 16949 - Automotive Quality Systems Standard 4
I CQI-15 Welding System Assessment 2nd edition - Does not require Ultrasonic Welding anymore? Customer and Company Specific Requirements 0
B ERP software validation - risk assessment vs validation scope ISO 13485:2016 - Medical Device Quality Management Systems 11
D 21 CFR Part 11 Assessment (Fully Compliant or Not) Qualification and Validation (including 21 CFR Part 11) 9
T Travis Perkins Group Online Assessment -Ccharge Misc. Quality Assurance and Business Systems Related Topics 9
T Risk Assessment and Management [Deleted] Misc. Quality Assurance and Business Systems Related Topics 1
P Scenario based risk assessment IEC 27001 - Information Security Management Systems (ISMS) 1
Q KPI risk assessment - Criteria for the given score IATF 16949 - Automotive Quality Systems Standard 3
D Internal auditor competence assessment Internal Auditing 13
Q Measurement Equipment Revocation - Looking for a Disposal Form with Risk Assessment IATF 16949 - Automotive Quality Systems Standard 10
Moncia Chemical risk assessment / COSHH Manufacturing and Related Processes 5
Ed Panek FDA Remote Regulatory Assessment (RRA) Overview 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
M REACH assessment of PCBA/finished product REACH and RoHS Conversations 2
J Risk Assessment of Lithium Ion Batteries FMEA and Control Plans 3
A Qualification of clinical assessment scales EU Medical Device Regulations 1
Q FMEA and Risk assessment in Microsoft Access FMEA and Control Plans 6
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
thisby_ Post Market/Production Risk Assessment ISO 14971 - Medical Device Risk Management 0
M Control-self assessment Internal Auditing 5
Q Self-assessment audit information Quality Management System (QMS) Manuals 6
N ISO 27001 for Jumb Burger - Risk Assessment sheet IEC 27001 - Information Security Management Systems (ISMS) 14
C Risk Assessment Tools ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Complex IEC 60601-1 gap assessment IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
_robinsingh Security Risk Assessment Tool IEC 27001 - Information Security Management Systems (ISMS) 2
S EU MDR CAPA - GAP Assessment on CAPA SOPs EU Medical Device Regulations 1
P NICE Health Technology Assessment in the UK UK Medical Device Regulations 0
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
M SemaTech SSQA Standardized Supplier Quality Assessment - my favorite tool ever Manufacturing and Related Processes 1
L Biological Assessment (ISO 10993-1) Other Medical Device Related Standards 1
E HONDA HAA QAV-1 Self Assessment General Auditing Discussions 6
P Conformity assessment based on a quality management system or production quality assurance EU Medical Device Regulations 3
R Risk assessment on IT containers and the information they contain IEC 27001 - Information Security Management Systems (ISMS) 4
B Threat/Vulnerability Catalogue for risk assessment IEC 27001 - Information Security Management Systems (ISMS) 4
R FOD Risk Assessment - What tools would you recommend for assessing FOD risk? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1

Similar threads

Top Bottom