Routine test for MD finished product

J

jayanthi

#1
Hi
We already tested our MD prototype for IEC 60601./Now for regular production, What are the test we have to make it routine in regular production to comply with IEC 60601. Is there any requirement in IEC std
?
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
It depends on what the regulatory system requires you to do. Generally, you need to perform leakage current, protective earthing and dielectric strength, cause this is mentioned in the second edition of IEC 60601 and thus has historically been the rouutine tests required by regulators (the third edition makes no mention to routine tests of the finished product).

From a response from another (http://elsmar.com/Forums/showthread.php?t=38433) thread:

The problem with dielectric strenght is that it´s a very destructive test. In Brazil, we are changing the routine tests required. We´ll begin using IEC 62353, which uses insulation resistance testing in place of the hipot test. Insulation resistance also measure the quality of the insulatio nbarriers, but does not damage the equipment.

You might use a rationale of this kind for justifying not implementing routine dielectric strenght testing, and then ask what your notified body thinks about it.
 
Thread starter Similar threads Forum Replies Date
E Routine production tests - dielectric voltage withstand test IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
N Heavy tare to simulate high load in a routine sensitivity test of a floor scale? General Measurement Device and Calibration Topics 3
T Nonconforming product at customer detected by a routine inspection by field service Nonconformance and Corrective Action 9
M Routine testing of medical electrical systems - What specific electrical safety tests should be performed? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
N Referencing of a standard's year in routine regulatory compliance documents Other Medical Device Related Standards 3
M Medical Device News FDA - Eliminating Routine FDA news 14-09-18 - Re-Review of Third Party 510(k) Reviews Other US Medical Device Regulations 0
S Routine Testing for Class I Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 24
N ISO 11135 Monitoring Routine ETO Sterilisation Parameters Other Medical Device Related Standards 3
C Dose Mapping - How to relate back to Routine Monitoring Position ISO 13485:2016 - Medical Device Quality Management Systems 3
B Number of Biological Indicators for Routine Monitoring of ETO Sterilization Cycle Other Medical Device Regulations World-Wide 8
J FDA Routine Inspection Pre-Anouncement - What will be checked? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
M Identifying Routine and Non-Routine Activities: OSHA OHSAS 18001 Occupational Health & Safety Management Standards 6
S How you define 'Normal & Abnormal' Conditions and 'Routine & Non-routine' Activities ISO 14001:2015 Specific Discussions 8
RoxaneB Environmental Objectives - Do they need to be linked into with Routine Indicators? Miscellaneous Environmental Standards and EMS Related Discussions 6
RoxaneB Search for another name for "Standardization Process" or "Routine Management" Quality Tools, Improvement and Analysis 4
D Line clearance - Routine components in the prep room for universal use ISO 13485:2016 - Medical Device Quality Management Systems 8
R Inspection and Detection - Kit to production - Need an inspection routine Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
E Test report to certify compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 1
E Tensile test machine, tinius olsen 602 Manufacturing and Related Processes 1
M Test failure Root cause not found Customer Complaints 10
Moumen H Variations between ASTM A29 Standard for steel bars and Mill test certificates specs Manufacturing and Related Processes 1
D Tip test 10° -> 5° IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Sponsor name presented in the test report EU Medical Device Regulations 4
M Packing Validation & Accelerated Aging Test ISO 13485:2016 - Medical Device Quality Management Systems 2
S OEM full range calibrations vs Validation special test points Medical Device and FDA Regulations and Standards News 0
C IEC 60601 - 8.8.3 Dielectric Strength test. 4kv being applied to the ground conductor?! IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Shelf Life Test for IFU and Implant Card Other Medical Device Related Standards 1
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
S Critical characteristic on manufacturing operations test procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
R IEC 60601-1 Clause 15.3.2, Push test IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Knee Implant (Femoral -Cobalt chrome)-Sub chronic toxicity test (ISO 10993-11)choice of root Medical Device and FDA Regulations and Standards News 2
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
A Is calibration of test weight required General Measurement Device and Calibration Topics 4
S Non parametric test for semi-quantitative data. Statistical Analysis Tools, Techniques and SPC 5
Ed Panek Disaster Recovery Test IT (Information Technology) Service Management 3
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
M Is it normal / sufficient to have only the IEC 60601-1-2 test report without indicating IEC 60601-1? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Z Is Op Amp Common-Mode Rejection Ratio (CMRR) test applicable to battery operated devices? Other Medical Device Related Standards 0
E When to perform accelerated aging studies and transport test(OQ or PQ) Qualification and Validation (including 21 CFR Part 11) 4
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
A Test requirements for marketing in US when RATED values are not of US IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
H Secondary Circuits, Voltage Test and Clearance/Creepage IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Fogging test as per DIN 75201(50ug/g ) VDA Standards - Germany's Automotive Standards 3
R HV Test of HF Surgical Unit IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R IEC 60601-1 - 11.1.3 e) Test criteria - Temperature Measurements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E 60950-1 resistance to abnormal heat test Various Other Specifications, Standards, and related Requirements 0
S User evaluation for self monitoring blood glucose test systems US Food and Drug Administration (FDA) 4
E MSA for Push and Pull test Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
Z IEC 60601-2-25; Frequency response test Medical Device and FDA Regulations and Standards News 1

Similar threads

Top Bottom