Risk of fire in an Oxygen rich environment - Fire Prevention - IEC 60601-1

F

freewind

#1
Hi everyone,

I have a question regarding a fire prevention clause in the 3rd edition of the IEC 60601-1.

Oxygen rich environment is defined as an environment in which the concentration of oxygen is greater than 25% for ambient pressures up to 110kPa or the partial pressure of oxygen is greater than 27.5kPa at ambient pressures exceeding 110kPa.

If i have an outlet discharging 35% oxygen into an enclosure (approx 270x300x450mm) with 2 exhaust fans and the measured oxygen level 10mm away from the outlet is only 22% oxygen; so oxygen greater than 25% is only in that 10mm radius around the outlet, is that enclosure still considered an oxygen rich environment?

Appreciate any input!

PS. If the fans were not working, the radius increases to 25mm.
 
Elsmar Forum Sponsor
M

MIREGMGR

#4
Whenever a technically prescriptive standard isn't sufficiently technically specific to properly address a particular application, or is technically inappropriate or just plain wrong for your technical approach (perhaps because it was developed before your technology was created), my understanding is you have three possible courses of action:

1. Consult with the regulatory body for which you are attempting to apply the technically prescriptive standard as to how to adapt or modify the standard's requirements so as to better address the application;

2. Or, similarly consult with all or a subset of your customers in order to arrive at an acceptable technical product-performance stance, then market your product with a clear statement of your alternate compliance approach to the standard in question;

3. Or, follow option 2 on your own, without participation by customers.
 

Randy

Super Moderator
#5
Do some research in the Apollo 1 fire and see what their data says. The basic situations are different, but the end result is what you're trying to prevent.
 
Thread starter Similar threads Forum Replies Date
A IEC 60601 11.2.2.1 Risk of Fire in an Oxygen Rich Environment, Source of Ignition IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
F Risk + Disaster Assessment, Fire Alarm, etc. - Records Management Business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Business Continuity for IVD manufacturers - Our most severe risk is fire Business Continuity & Resiliency Planning (BCRP) 4
Marc Millions of Ford vehicles have fire risk part - Cruise-control deactivation switch World News 0
K Semi S14-0200 Fire Risk Assessment or S2-0200 Fire Protection Criteria Misc. Quality Assurance and Business Systems Related Topics 1
B ISO 17025:2017 risk management Risk Management Principles and Generic Guidelines 0
Q FMEA and Risk assessment in MS ACCESS FMEA and Control Plans 2
I Realization processes input into overall risk ISO 14971 - Medical Device Risk Management 2
M Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
thisby_ Post Market/Production Risk Assessment ISO 14971 - Medical Device Risk Management 0
S Risk Management Review ISO 14971 - Medical Device Risk Management 4
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
S Risk Management and other Files ISO 14971 - Medical Device Risk Management 8
silentmonkey Overall Benefit/Risk Analysis - Risk Management VS Clinical Evaluation ISO 14971 - Medical Device Risk Management 3
N ISO 27001 for Jumb Burger - Risk Assessment sheet IEC 27001 - Information Security Management Systems (ISMS) 11
C Risk Assessment Tools ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
qualprod Examples to mitigate risk from Covid ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G Risk of stopping your customer's line IATF 16949 - Automotive Quality Systems Standard 4
C Risk Matrix vs FMEAs ISO 14971 - Medical Device Risk Management 4
S IVD risk class II devices for Brazil and MDSAP Other Medical Device Regulations World-Wide 0
M ISO 14971:2019: Criteria for overall residual risk ISO 14971 - Medical Device Risk Management 6
M ISO14971:2019 - Verification of implementation and effectiveness of risk control ISO 14971 - Medical Device Risk Management 3
Aymaneh Medical Device Cybersecurity Risk Management IEC 27001 - Information Security Management Systems (ISMS) 2
S Traceability of requirements to design and risk Design and Development of Products and Processes 3
R Risk control measures as per ISO 14971 ISO 14971 - Medical Device Risk Management 6
D Deciding whether or not pre-market clinical investigation is required for low risk device EU Medical Device Regulations 5
R The term "Benefit Risk Ratio" in EU MDR, do I need to present benefit risk analysis as a RATIO Risk Management Principles and Generic Guidelines 4
_robinsingh Security Risk Assessment Tool IEC 27001 - Information Security Management Systems (ISMS) 0
A 21 CFR 820 - Risk Management - Looking for some guidance US Food and Drug Administration (FDA) 3
bryan willemot Contract Review and risk managment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D Risk Analysis using Monte Carlo Simulation instead of Scoring and Heat Map Risk Management Principles and Generic Guidelines 2
Sravan Manchikanti Software Risk Management & probability of occurrence as per IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
E Normal Condition Hazards in Risk Analysis ISO 14971 - Medical Device Risk Management 3
silentmonkey Rationalising the level of effort and depth of software validation based on risk ISO 13485:2016 - Medical Device Quality Management Systems 10
R Risk assessment on IT containers and the information they contain IEC 27001 - Information Security Management Systems (ISMS) 4
B Threat/Vulnerability Catalogue for risk assessment IEC 27001 - Information Security Management Systems (ISMS) 4
R Opportunity For Improvement vs Opportunity (Positive Risk) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
R FOD Risk Assessment - What tools would you recommend for assessing FOD risk? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
A ISO 14971 PFMEA Manufacturing Risk ISO 14971 - Medical Device Risk Management 2
Q Example of the Risk Template Document Control Systems, Procedures, Forms and Templates 1
K Overall residual risk according to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 5
A Risk Number for each software requirement IEC 62304 - Medical Device Software Life Cycle Processes 7
D Importing a general wellness low risk product Other US Medical Device Regulations 3
C Quantifying risk in choosing the number of parts, operators and replicates in a GR&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R AQL, Consumer Risk and MA Statistical Analysis Tools, Techniques and SPC 2
M Risk managment report of Surgical Mask Example ISO 14971 - Medical Device Risk Management 14
M Risk Analysis Flow - Confusion between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
R ECG Risk Analysis Standards ISO 14971 - Medical Device Risk Management 2
N Device Labeling - Medtronic Ventilator Files (Risk Management documents) Coffee Break and Water Cooler Discussions 2

Similar threads

Top Bottom