EMC & Safety Testing of the product with the same Sr. No. for EC Declaration

Harsh

Involved In Discussions
#1
Hello Everyone,

I was wondering for the EMC & Safety testing that for the testing is there any specific requirement to test the product with the same serial number for EC Declaration. I mean is it mandatory to have the same Sr. No. in all the test reports as these do not seem feasible to me in case we opt for multiple testing labs for testing the product.

For example, testing our products for the applicable 11 tests of EMC & EMI, we can send our product to two different labs simultaneously as one lab is accredited for testing according to 9 tests & another one for the two remaining tests. By opting for the method of sending multiple products simultaneously we can reduce the time of testing by a huge margin. I do want to confirm one thing that all the products which would be sent to the multiple labs must be identical when it comes to the internal & external components.

Please do let me know if any specific requirements are already present & I am missing those.

Thanks in advance.
 
Elsmar Forum Sponsor

CharlieUK

Quite Involved in Discussions
#2
No reason at all - most companies use different samples as EMC testing generally requires more thorough operating modes and monitoring.

What is important is that you know the build state of each, as that is what is being tested (and perhaps certified)
 

Harsh

Involved In Discussions
#3
Thanks, Mr. Charlie. That means there are not any current provisions or restrictions in the EMC & LVD directives & their harmonized standards regarding testing of single sr. no. product for EC declaration right?
 

CharlieUK

Quite Involved in Discussions
#4
that's correct
You can perform compliance testing using as many samples as you like - there's no "cumulative effect" of the tests that needs to be assessed
 
Thread starter Similar threads Forum Replies Date
B Evaluation of Basic Safety during EMC Immunity or Climate Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
Y New Japanese EMC/electrical safety standards - Additional product testing required? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
H Regarding the validity of EMC & Safety test reports without NABL & ILAC-MRA mark. CE Marking (Conformité Européene) / CB Scheme 2
H Regarding EMC & Safety retesting requirements of the product CE Marking (Conformité Européene) / CB Scheme 2
M EMC Directive and product safety standards CE Marking (Conformité Européene) / CB Scheme 1
H External power supply - requirements in safety/EMC test? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
O Guide on EMC for Functional Safety CE Marking (Conformité Européene) / CB Scheme 3
B Safety & EMC certificate updated when MCU (MIcro-Controller) is changed? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Device with Safety & EMC Test Certificates from different Laboratories ISO 13485:2016 - Medical Device Quality Management Systems 22
M Combining EcoDesign with Compliance (Product Safety/EMC) Engineer Career and Occupation Discussions 2
C IEC60601-1-2 :2020 EMC Reliability Analysis - Predictions, Testing and Standards 2
D IEC 60601-1-2: Is EMC immunity testing required for a device without essential performance? IEC 60601 - Medical Electrical Equipment Safety Standards Series 25
S What EMC 60601-1-2 version to use with 60601-2-47 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
D Essential performance and EMC immunity testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M IEC 60601-1-2 EMC Tables IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
L IEC60601-1-11 Home Healthcare + IEC60601-1-2 EMC (Functional Earth allowed?) IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
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
F EMC testing for a system that is provided with a computer IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
O EMC - EFT (Electrical Fast Transients) on SIP couples erroneously with other cable CE Marking (Conformité Européene) / CB Scheme 1
K Is a 3V torch classified as medical electrical equipment needing EMI/EMC testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Arguing with the test lab about failing in an EMC test IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
E Airborne Medical Equipment EMI/EMC IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S Portugal ISO 13485 Certification and EMC Test Houses Other Medical Device and Orthopedic Related Topics 3
T Question: Do we consider 60601-1-2 (4th ed) EMC testing a mode for a diagnostic port? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
O Medical Device EMC Risk Management CE Marking (Conformité Européene) / CB Scheme 4
T CE Marking & Compliance to MDD, EMC, RoHS, and GPSD REACH and RoHS Conversations 4
J IEC 60601-2-2 - EMC Requirements - Surgical instrument manufacturer IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
O EMC testing per IEC 60601-1-2 for considering new cables CE Marking (Conformité Européene) / CB Scheme 1
O EMC testing under RED and IEC 60601-1-2 CE Marking (Conformité Européene) / CB Scheme 1
D EMC Testing for a Production Fixture CE Marking (Conformité Européene) / CB Scheme 0
Q IVD vs EMC OJ (Official Journal of the European Union) Harmonised Standard Conflicts EU Medical Device Regulations 1
A EMC Emission Issues - Communication between PC and Monitor IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
F Is EMC + Radio Re-Test Required? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
E Particular standards, essential performance in EMC Immunity Test IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
F EMC (Electromagnetic Compatibility) Conformity Charts - IFU Requirements Misc. Quality Assurance and Business Systems Related Topics 3
G CE Marking - Low Voltage Directive and EMC Directive CE Marking (Conformité Européene) / CB Scheme 4
T Firmware version in EMC report / DoC CE Marking (Conformité Européene) / CB Scheme 1
W EMC, ESD for battery operated apparatus Other Medical Device and Orthopedic Related Topics 1
N New EMC IEC60601-1-2 4.0 Ed. Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
B What is our requirement for maintaining the EMC series of standards? IEC 61000 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
P EMC requirements for an accessory to a medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
T EMC for Medical Devices in Home Environment Other US Medical Device Regulations 4
J EMI/EMC Test differences for Radiography Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M EMC Testing for a US-only, Home-Based Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
T EMC Tests - While certified power supply is part of device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B EMC Repeat Justification - Reducing NRTL testing required after modification of ME IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
C EMC Test Report Requirements to IEC 60601-1-2:2009 ISO 13485:2016 - Medical Device Quality Management Systems 4
O CE TCF (Technical Construction File) Template for LVD/EMC/Pressure Directive CE Marking (Conformité Européene) / CB Scheme 5
P New EMC standard IEC 60601-1-2:2014 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
T IEC 60601-1-2 EMC and WiFi IEC 60601 - Medical Electrical Equipment Safety Standards Series 8

Similar threads

Top Bottom