Testing Laboratories in Europe to IEC/EN 60601-2-47

T

tallu

#1
Any recommendation where to test device against IEC/EN 60601-2-47?

Does someone knows any test lab in Europe?
 
Elsmar Forum Sponsor

Peter Selvey

Staff member
Super Moderator
#3
Are you just interested in performance tests such as sensitivity/noise/frequency response/input impedance etc (201.12.4 in the 2012 edition), or the database tests (201.12.1, AHA, MIH, EST, etc)?

There is a big difference between the two, Clause 201.12.4 is relatively easy and many labs of the major agencies (TUVs, UL, CSA etc) now have the equipment to do these tests themselves, just need to ask around.

However Clause 201.12.1 is highly specialized and generally done by the manufacturer, the labs would normally exclude or use the manufacturer's data.
 
T

tallu

#4
Performance tests. Any advice? Should manufacturer perform tests inhouse or in test laboratory?

Database tests are easier to perform internally.
 

Peter Selvey

Staff member
Super Moderator
#5
Depends on a lot of things ...

For most modern regulations (Europe, USA, Australia, Canada, Japan etc), in house testing is OK as long as it can stand up to auditor/reviewer checks. Use qualified people, traceable equipment, validated set ups and keep good records and there should be no problem.

Known exceptions are China and Brazil. Brazil will accept reports from accredited labs, China is a bit unclear. There may be forum members with more experience on those countries than me.

If you are looking at product certification (mark on your product), you need to check with the agency what they will accept. Some will accept manufacturer tests without much effort, some will want to witness the tests, and some might prefer to do it themselves.

Lastly there is marketing, some manufacturers prefer a third party lab report as it looks better.
 
#8
Very helpful! Is in-house testing still OK for new 60601-2-47 applications? Do you think any certifications/accreditations would be required?
 

Peter Selvey

Staff member
Super Moderator
#9
There's always going to be standards like IEC 60601-2-47 which are difficult, rarely requested and subjective, so it's not economical for third party labs to be set up for. As such, modern regulations will never insist that accredited testing is required. However, agencies (e.g. Notified Bodies, auditors) may imply that third party testing is required, but really that's just a preference to make their life easier. If it's accredited, they can just record the report number, testing agency etc and move on. If it's not, they (should) check the detail in the reports, qualifications of persons doing, equipment is calibrated, raw data, completeness etc etc etc, which is a lot of work.

Some regulations (Brazil? China?) might insist on third party testing. However, this would be lip service only. Most labs are not set up so if a report existed it would be some form of a fudge, or detail would show the lab didn't really do the testing.
 
Thread starter Similar threads Forum Replies Date
E Rich O2 Environment Testing Laboratories (Clause 11.2.2 ME EQUIPMENT and ME SYSTEMS) IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
M ROHS & REACH in TEFLON Material - NABL Testing Laboratories REACH and RoHS Conversations 1
W IEC 60601-1-2 Testing Laboratories in the Middle East IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
S FDA Establishment Registration for Testing Laboratories 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
E Validation of Method(s) in Testing Laboratories General Measurement Device and Calibration Topics 9
J European Laboratories which can do IEC/EN 60601-2-50 Testing? (Close to Turkey) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
J ISO 17025 and Testing Laboratories Mentor / Advisor Needed ISO 17025 related Discussions 6
thisby_ EMC/FCC part 15 test (NRTL - Nationally Recognized Testing Laboratories) required? US Food and Drug Administration (FDA) 1
R AC7101/11 Nadcap Audit Criteria for Materials Test Laboratories ? Fastener Testing Various Other Specifications, Standards, and related Requirements 1
D Difference between Calibration, Testing and Inspection Laboratories? General Measurement Device and Calibration Topics 6
R Calibration Companies - IASonline.org under Testing Laboratories General Measurement Device and Calibration Topics 12
Q Internal Testing and Calibration Laboratories - MSA, Gage R&R and Control Plans IATF 16949 - Automotive Quality Systems Standard 2
R GB9706.1:2020 - in-country testing China Medical Device Regulations 0
A Bench Testing US Food and Drug Administration (FDA) 2
R Validation of Software used in Verification Testing ISO 13485:2016 - Medical Device Quality Management Systems 2
M Do i need to have equipment validation if 100% testing is completed? Qualification and Validation (including 21 CFR Part 11) 4
E Biocompatibility testing of our applied part seems redundant Other Medical Device Related Standards 2
A Recommended testing methods for weather stripping Manufacturing and Related Processes 6
T Shrinkage Testing for EPDM Material Various Other Specifications, Standards, and related Requirements 5
J Managing design verification regression testing of design changes Design and Development of Products and Processes 1
D Conductivity Water Samples testing temperature Qualification and Validation (including 21 CFR Part 11) 2
G Pricing Structure for Physical Mechanical Testing of Labs Manufacturing and Related Processes 1
S Skipped/Reduced testing in Pharma for Raw materials and Intermediates Manufacturing and Related Processes 0
S Pharmaceutical Shelf Life Testing Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
D How to testing of Pressure relief valve as per API 6D ? Oil and Gas Industry Standards and Regulations 1
J Impact Testing--Is conversion between Izod and Sharpy Possible? General Measurement Device and Calibration Topics 3
O Should a Covid vaccine and testing policy be included as part of ISO9001 or AS9100 risk management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
V How to select the tests for proficiency testing Measurement Uncertainty (MU) 0
B Customer Preference Testing Customer and Company Specific Requirements 2
N Pre-Clinical Performance Testing Design and Development of Products and Processes 3
I Software (SaMD) mobile application verification testing: objective evidence Medical Information Technology, Medical Software and Health Informatics 2
I How to find required testing for a specific device? Other US Medical Device Regulations 3
J CQI-9v4 Alternative TUS Testing Methods Various Other Specifications, Standards, and related Requirements 0
M ASTM F1717 Static and Dynamic Testing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Mold Limits for Microbiology Testing Other Medical Device Related Standards 3
S Orthopedic implant sterility testing Medical Device and FDA Regulations and Standards News 1
H Independence between the development and testing IEC 62304 - Medical Device Software Life Cycle Processes 6
M Issues with leakage current testing for a CLASS II device since no PE and FE is present IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Testing criteria - where to place Design and Development of Products and Processes 2
E 60601-1 - Tilt testing - Tensile safety factor IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
V Setup for testing against ISO14708 clause 16 (protection of the patient from herms caused by heat) Other Medical Device Related Standards 0
gramps What do you think about automated QA testing For software app industry? Misc. Quality Assurance and Business Systems Related Topics 5
B In house NIOSH pre Testing accepted by NIOSH? US Food and Drug Administration (FDA) 1
M Bacteriostasis/Fungistasis Testing Other Medical Device and Orthopedic Related Topics 6
P Sample Size for Distribution Simulation Testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
N EN 813, EN 12277, EN 1497 - Testing some harness prototypes to an EN standard Various Other Specifications, Standards, and related Requirements 0
S What should i choose for "testing procedure" characteristics? (N95) General Information Resources 0
D Essential performance and EMC immunity testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 12
Q Summative Usability Evaluation Testing: prior or during Clinical Investigation? Human Factors and Ergonomics in Engineering 10

Similar threads

Top Bottom