# Question on Table 6 "Test voltages for solid insulation forming a MEANS OF PROTECTION

P

#### ps_alsa

In 60601-1 3rd Edition 2007, Table 6 shows "Test voltages for solid insulation forming a MEANS OF PROTECTION".
Voltage reference to be used is Peak Working Voltage; regarding the "Protection from Mains Part" column "One Means of patient protection" is there someone who can explain me why Test value is multplied by sqrt of 2 and summed to 1000 up to 1414 Vpk and for a reference voltage higher than 1414 this voltage is divided by sqrt of 2?
It seems for reference voltages from 1414 Vpk, calculation uses its rms Value...not so clear the reason
Paolo

Moderator
Re: Question on Table 6 "Test voltages for solid insulation forming a MEANS OF PROTEC

For a working voltage (U) above 1414V the test voltage is U divided by root 2 +2000

The figures are derived from other standards such as 60950 (IT equipment) and 60664 (insulation co-ordination) as well as retaining values from the old edition 2 version of 60601.

Check the informative rationale, at Annex A, for some more details.

CQI-12 2nd Edition - Table D, question 2.1 - Powder Coat Painting IATF 16949 - Automotive Quality Systems Standard 4
R CQI-9 Heat Treatment Process Table C question IATF 16949 - Automotive Quality Systems Standard 3
Thermoplastic Elastomer Tolerance Table - ISO 3302 / RMA tolerance question Other ISO and International Standards and European Regulations 3
Question on Finding - BSI Stage 2 ISO 13485:2016 Certification - PMS ISO 13485:2016 - Medical Device Quality Management Systems 5
Quick question about 9001 Quality Objectives Manufacturing and Related Processes 9
PROCESS OWNERSHIP (QUICK QUESTION) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
Private Label Manufacturer Question Canada Medical Device Regulations 2
Question on finding • Failure to follow Work Instructions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
A question about Null Hypothesis for 1 Sample T-test Statistical Analysis Tools, Techniques and SPC 6
AS9102B Form 1, line 19 question. Is a printed name and signature both required or is only a signature sufficient? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
Question on registration of class 1 medical device in Turkey Other Medical Device Regulations World-Wide 0
General FMEA Question FMEA and Control Plans 2
What do you think of Chat GPTs answer to this Risk Acceptability question? ISO 14971 - Medical Device Risk Management 5
ISO 13485 Supplier Question ISO 13485:2016 - Medical Device Quality Management Systems 13
Question regarding new VDA_AIAG fmea approach for process FMEA FMEA and Control Plans 0
FDA Submission Question US Medical Device Regulations 3
Cleanroom Question Manufacturing and Related Processes 10
Aircraft GAPP Software Testing Compliance Question AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Quick question M3 screw plug gauge AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
FDA regulations medical device prescription fulfillment DME question US Medical Device Regulations 0
An interesting question about import company Other Medical Device Regulations World-Wide 5
Question about training Training - Internal, External, Online and Distance Learning 20
Labeling question about different manufacturers on a single label Manufacturing and Related Processes 4
Question regarding classification of custom made device EU Medical Device Regulations 5
Question about granite surface plates out of spec AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
MDR question - Meaning of Stability CE Marking (Conformité Européene) / CB Scheme 6
GD&T Question, True Position Confusion Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
Initial Importer question Other US Medical Device Regulations 2
Calibration question Manufacturing and Related Processes 4
Class Exempt Medical Device Recall Question US Food and Drug Administration (FDA) 3
Metric or Imperial; that is the question... After Work and Weekend Discussion Topics 6
Can someone help me with this CMM programming question? Manufacturing and Related Processes 2
A strange question about predicate device selected in 510(k) submission Medical Device and FDA Regulations and Standards News 8
Question regarding AQL - ISO 3951 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
Document Control Question involving DocuSign US Food and Drug Administration (FDA) 6
Question about Customer Supplied Equipment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
ISO 13485: 2016 Lot numbering question ISO 13485:2016 - Medical Device Quality Management Systems 4
Nadcap - Heat Treatment Proof of Verification question for Digital results AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Question of Calibration Cycles AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
Software Validation Question ISO 13485:2016 - Medical Device Quality Management Systems 10
8.5.1.1 Control Plan - question audit NC IATF 16949 - Automotive Quality Systems Standard 5
Document Identification Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Question regarding PCR workstation Fume Hood upon first use ISO 13485:2016 - Medical Device Quality Management Systems 0
ISO 9001 calibration question please ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Quick question on the sequence of ISO 17025 external audits ISO 17025 related Discussions 14
ISO 13485--Question regarding performing calibrations in house. ISO 13485:2016 - Medical Device Quality Management Systems 13
Document numbering question? ISO 13485:2016 - Medical Device Quality Management Systems 7
Has the facility been inspected? question in Certificate to Foreign Government application Other US Medical Device Regulations 0
ESTAR 510(k) submission question Medical Device and FDA Regulations and Standards News 0
Question on clause 5.2.2 IEC 62304 - Medical Device Software Life Cycle Processes 2