Applicability of Means of Protection, working voltage in an Automated External Defibrillator

#1
Dear Experts,

I am currently designing an AED device.
My device is internally powered and has a plastic enclosure. the patient connections are defib electrodes, used for ECG acquisition and defib shock.
In my design, the high-voltage (2000V) and low-voltage (18V) parts have a common Ground plane (GND). I sent my design for validation to a test lab.
But reviewing my architecture, the test lab for certification considers that ALL the electronic board has a WORKING VOLTAGE of (2000V) due to this common ground.
So the test lab considers that I need MOP 2000V isolation between the high-voltage circuit and electrodes, and also MOP 2000V isolation between the ECG path and electrodes, which means that the ECG path resistors should withstand 4kV D.C. because bridging a 2000V MOP (according to 60601-1 ed.3 sect. 4.8).

On my side I have a totally different interpretation of the regulation:
- I consider the WORKING VOLTAGE of my device to be 18V ( according to 60601-2-4 chapter 201.8.8.3 : For the dielectric tests of the general standard, the WORKING VOLTAGE is determined without regard to the presence of defibrillation or pacing voltages.)
- I consider that High-voltage is isolated from Low-voltage of circuit (even if common ground). This is proven by validation test of 60601-2-4 201.8.8.3
- So I don't need MOP 2000V isolation between ECG path and electrodes
- I don't need MOP 2000V isolation between High-Voltage Circuit and electrodes, because current is intended to flow through patient (60601-1 ed.3 sect. 8.4.1)
- BUT I need to pass all the tests of 60601-2-4.

Could someone tell me if my approach is ok or am I totally wrong in my comprehension of 60601-1 and 60601-2-4?


Thanks in advance!

Mars
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
E Medical device applicability to WEEE Other ISO and International Standards and European Regulations 2
S Defibrillator Protection applicability When using Multiple applied parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D ISO 14971 applicability in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
F Applicability of CSR's IATF 16949 - Automotive Quality Systems Standard 1
A Applicability of Photobiological Safety Evaluation for LED used in medical devices Reliability Analysis - Predictions, Testing and Standards 2
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
S Applicability of 60601 vs. 60335 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Applicability of Cybersecurity EU MDR 2017/745 Annex 1 23.4(ab), 14.2(d) CE Marking (Conformité Européene) / CB Scheme 3
K Applicability of eIFU as per EU MDR 2017/745 Annex 1 23.1 CE Marking (Conformité Européene) / CB Scheme 0
R MDD x PPE Directive - Statement of Non-Applicability EU Medical Device Regulations 3
B Exclusions or justification for non-applicability of IEC standards Reliability Analysis - Predictions, Testing and Standards 1
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Qualification and Validation (including 21 CFR Part 11) 5
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 4
N EU MDR - Applicability Article 22 Systems and Procedure Packs CE Marking (Conformité Européene) / CB Scheme 4
R Applicability of new non-harmonized standards (MDD/MDR) EU Medical Device Regulations 14
A MDR Article 22 applicability - Legal manufacturer EU Medical Device Regulations 8
K Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 7
V Applicability of IEC 62366-1 usability to resorbable bone substitutes IEC 62366 - Medical Device Usability Engineering 9
E Commission Regulation (EU) No. 207/2012 E-IFU Applicability EU Medical Device Regulations 5
M ROHS : Applicability for AIMDs RoHS, REACH, ELV, IMDS and Restricted Substances 2
L Dying a slow SCOPE death - NEW ISO APG Paper on Scope and Applicability May 2020. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M Applicability of IEC 60950-1 Table K2 - Minimum clearances between circuits Various Other Specifications, Standards, and related Requirements 0
R Applicability of ISO 14708-3 RF Transmitter and Implantable RF Receiver Other Medical Device Related Standards 1
R Applicability of ISO 14708-3 - RF transmitter and implantable RF receiver Other Medical Device and Orthopedic Related Topics 1
M Oxygen enriched environment applicability - Operating table used in general surgeries in hospital IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
E CB scheme applicability for battery powered medical devices CE Marking (Conformité Européene) / CB Scheme 0
I IATF 16949 - 8.4.2.3 - Applicability to Shipping Suppliers IATF 16949 - Automotive Quality Systems Standard 11
S CQI-12 - Applicability to Raw Materials Customer and Company Specific Requirements 1
C Applicability of ISO 9001:2015 Section 8.5 - Engineering company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Applicability of EN 13795 for Incise Drape EU Medical Device Regulations 0
S Applicability of the standard IEC 60601-2-18 to an arthroscopy pump IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Q Partial non applicability of ISO 9001 Cl. 7.1.5 (not having services)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M User Interface of Unknown Provenance (UOUP) applicability IEC 62366 - Medical Device Usability Engineering 8
E Applicability of Low Voltage Directive (LVD) for 12V equipment CE Marking (Conformité Européene) / CB Scheme 4
Y Counterfeit Parts - AS9100 D Cl. 8.1.4 - Can I claim no applicability? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
M IEC 62304 Applicability - GUI Control Software IEC 62304 - Medical Device Software Life Cycle Processes 3
D Clarification of Applicability of TS 16949 Requirements to a Non-Automotive Business IATF 16949 - Automotive Quality Systems Standard 13
Richard Regalado Sharing a Statement of Applicability (SOA) for ISO/IEC 27001:2013 IEC 27001 - Information Security Management Systems (ISMS) 2
G Not quite old news: Statement of Applicability IEC 27001 - Information Security Management Systems (ISMS) 3
G Question on Statement of Applicability (SOA) IEC 27001 - Information Security Management Systems (ISMS) 2
L TS 16949 applicability for Supplier's Supplier IATF 16949 - Automotive Quality Systems Standard 8
R ISO 22000:2005 Clause 7.10.4 Withdrawal - Applicability and documentation required? Food Safety - ISO 22000, HACCP (21 CFR 120) 3
A Applicability of electrical safety standards to a dedicated PC IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
A Help me understand the applicability of 21 CFR Part 820.198 (Customer Complaints) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Y New Draft FDA Guidance for Applicability of GLP in Medical Device Submission Other US Medical Device Regulations 2
G TS 16949 applicability for Bulk Material Product IATF 16949 - Automotive Quality Systems Standard 25
Q Two AS9102 Applicability and Interpretation Questions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
R HIPAA (Health Insurance Portability and Accountability Act) applicability Other US Medical Device Regulations 3
E Applicability of Defibrillator Energy Test to Implantable Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
S OEM Supplier of Accessories Registration and 21 CFR 820 QSR Controls Applicability 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11

Similar threads

Top Bottom