SBS - The best value in QMS software

Question related to Single Fault Conditions

P

ps_alsa

#1
In 60601-1 III ed. in 8.1 b) the Standard states:
"SINGLE FAULT CONDITION includes:
- short circuit of any one insulation that complies with the requirements for one MEANS OF
PROTECTION as specified in 8.8;
NOTE This includes short circuiting of either constituent part of DOUBLE INSULATION that complies with 8.8."

This means:
all insulations that constitute a MEANS OF PROTECTION (i.e. all the insulations existing on my eletromedical device)
OR
all insulations that constitute a MEANS OF PROTECTION part of double insulation ?
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
I personally can't help, but here is a quick "Bump" - My Thanks in advance to anyone who can help with this one.
 
#3
- short circuit of any one insulation that complies with the requirements for one MEANS OF PROTECTION
The SFC requirement applies to all insulations (that provide a MOP).
But each insulation is shorted separately - one at a time.

For double insulation that means 2 tests - one for each half of the double insulation.
 
Thread starter Similar threads Forum Replies Date
D Equipment Register related question ISO 13485:2016 - Medical Device Quality Management Systems 1
S Interesting ITAR related question from our Certification Body ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
R Six Sigma / DPMO Related Inquiry - A 6 Sigma related Statistical Sampling question Six Sigma 2
ScottK Z-Score question: Is this Z related to the normal distribution Z values? Six Sigma 3
W Question on Clause 7 Design Related Exclusions Design and Development of Products and Processes 19
Q ISO 9001/IATF 16949 Audit Finding Question - Document Retention IATF 16949 - Automotive Quality Systems Standard 0
J IATF 16949 Calibration/Verification records question ISO 26262 - Road vehicles – Functional safety 2
I IMDS Error Message Question RoHS, REACH, ELV, IMDS and Restricted Substances 1
lanley liao Question regarding the calibration of monitoring and measure equipment. Oil and Gas Industry Standards and Regulations 0
C Gauge R&R Question Using Minitab Software 1
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
K Question on MDR classification EU Medical Device Regulations 4
D Question on equipment - when to use reference only or research only stickers ISO 13485:2016 - Medical Device Quality Management Systems 5
D Work Instruction Question ISO 13485:2016 - Medical Device Quality Management Systems 5
M Clinical Decision Support Software Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
John C. Abnet VDA 6.3 - Question 7.3 - "blocking of parts" VDA Standards - Germany's Automotive Standards 6
D Approved supplier list - Distributors question ISO 13485:2016 - Medical Device Quality Management Systems 6
D Equipment Register and PM question ISO 13485:2016 - Medical Device Quality Management Systems 2
D Question regarding "storage and distribution" ISO 13485:2016 - Medical Device Quality Management Systems 1
D Calibration tolerance question using Pipettes Medical Device and FDA Regulations and Standards News 3
D Question regarding customer feedback process ISO 13485:2016 - Medical Device Quality Management Systems 3
S Study sign off question / responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 3
S Qualification question - ISO 13485 - Setting up a small lab Reliability Analysis - Predictions, Testing and Standards 2
M Question for Auditors - "Off the Record" Conversation? General Auditing Discussions 14
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
A Question on Authorized Representative in Malaysia Other Medical Device Regulations World-Wide 3
D Limited Scope for second site Question? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
Anonymous16-2 Labeling Question (Dietary Supplements/Food) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
T Question for: Cg & Cgk calculation General Measurement Device and Calibration Topics 3
N ASL Question for GitHub ISO 13485:2016 - Medical Device Quality Management Systems 6
hogheavenfarm GDT Flatness measurement question Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
A Question on ISO 14001:2015 - Are annual audits required? ISO 14001:2015 Specific Discussions 11
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Another DFAR question 252.225-7009 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
F Conflict Mineral Smelter Question RoHS, REACH, ELV, IMDS and Restricted Substances 8
R NRTL - Scope Question - Off-the-Shelf Plug In IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D API 6A Certification Question Oil and Gas Industry Standards and Regulations 4
dinaroxentool Question about qualification as a medical device or accessory in Europe EU Medical Device Regulations 2
R DHR question: Traceability of components ISO 13485:2016 - Medical Device Quality Management Systems 2
C MDR - Question around software accesories EU Medical Device Regulations 2
K My question is, what/when is a nonconformity? Therefore what requires an NCR? Nonconformance and Corrective Action 9
Watchcat Authoritative References about the Research Question? Quality Tools, Improvement and Analysis 0
T Question about Quality Department employee position titles Quality Manager and Management Related Issues 10
N Question on creepage/clearance requirements for HF Active Accessories for 2nd edition 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
J Question: How to create an IMDS RoHS, REACH, ELV, IMDS and Restricted Substances 3
K Question on whether IEC 60601-2-62 standard is applied IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
B QMS question in regards to multiple medical devices/products and N/A activities Other Medical Device Related Standards 12
C NB approval - Basic question about Notified Bodies and their role EU Medical Device Regulations 10

Similar threads

Top Bottom