Oxygen enriched environment applicability - Operating table used in general surgeries in hospital

M

mehrnaz

Starting to get Involved
#1
#1
Hi all,
there is an operating table which is used in general surgeries in hospital. as far as I am concerned, the sub-clause 11.2 Fire prevention of 60601-1 relates to circuits which are suitable in the presence of Oxygen with the amount greater than 25%. is it correct to consider that device for compatibility to this sub-clause? the equipment has a control box with a transformer 220:24 and for relays for actuators, which I suppose can not be excluded in single faults of oxygen enriched environment.
however I assume as the control box is below a metal table top and has a compartment maybe it could be correct to no consider this clause.

thanks in advance
 
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
N Medical Devices in oxygen rich environment IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
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
K What is mean by Oxygen Rich Environment as per the IEC 60601-1 clause no 11.2.2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
P IEC 60601 11.2.2 - Oxygen Rich Environment sources of ignition IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
C Requirements for dissolved oxygen and/or head space oxygen in Pharmaceuticals Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
S Oxygen mask and nebilzer mask Applied standards EU Medical Device Regulations 2
M Regulations for oxygen/air-tubing and connectors inside of ME equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
F Heat and Moisture Oxygen Port Changes Classification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T CFDA issues notice for Small Oxygen Respirators (9/16/2013) China Medical Device Regulations 0
B Defining Expected Oxygen Leakage for Safety Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Ronen E Nidek Medical Class I recall: Medical Mark5 Nuvo Lite Oxygen Concentrators Other US Medical Device Regulations 0
N Chemical Oxygen Demand (COD) Determination in Industrial Waste Water General Measurement Device and Calibration Topics 5
R Testing Medical Equipment used in conjunction with Oxygen Rich Environments IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M Oxygen Data Logger that we can place with each shipment via aircraft ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
T Is Oxygen a Drug per FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
A An Example of a Risk Analysis Report for a Class II Medical Device (Oxygen Mask) ISO 14971 - Medical Device Risk Management 29
A Recreational Oxygen Concentrator - FDA or other requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
H Oxygen Purity Requirements - Oxygen to use in electrical arc furnace ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
F Risk of fire in an Oxygen rich environment - Fire Prevention - IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
sonflowerinwales Oxygen gauge on Nitrogen supply ISO 13485:2016 - Medical Device Quality Management Systems 16
F Oxygen Concentrator Hazards ISO 13485:2016 - Medical Device Quality Management Systems 9
ScottK Oxygen Cleaning and Surfactants used for leak detection Various Other Specifications, Standards, and related Requirements 1
S Do we need to submit our memory foam oxygen mask gasket for FDA approval? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C How about the classification under 93/42/EEC? Sterile oxygen mask ISO 13485:2016 - Medical Device Quality Management Systems 7
G Process monitoring of portable & stationary oxygen units: Can we use Cpk, Ppk, SPC ? Capability, Accuracy and Stability - Processes, Machines, etc. 3
G Process monitoring - Stationary and portable oxygen units ISO 13485:2016 - Medical Device Quality Management Systems 1
D Controlled Environment requirements Miscellaneous Environmental Standards and EMS Related Discussions 1
D Infrastructure: Equipment, Work Environment and Contamination Control ISO 13485:2016 - Medical Device Quality Management Systems 4
F Hi friends, can anyone show me an example of a procedure for ISO 13485 6.4.1 Work Environment? ISO 13485:2016 - Medical Device Quality Management Systems 2
M Informational US FDA draft guidance – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Medical Device and FDA Regulations and Standards News 0
B Practical ideas for information labelling in healthcare environment IEC 27001 - Information Security Management Systems (ISMS) 2
I CAP/CLIA Environment - Part 11 Compliance Qualification and Validation (including 21 CFR Part 11) 3
G Infrastructure and Environment for the operation of processes (ISO 9001 7.1.3 & 7.1.4) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Informational DITTA White Paper on Cybersecurity: Best Practices in the Medical Technology Manufacturing Environment Medical Device and FDA Regulations and Standards News 0
I Documents for Manufacturing Environment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
L PC in patient environment - BF applied part that uses USB to connect to PC IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
M AS9100d (section 7.1.3) example of compliance in machine shop environment. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
G ISO 17025 - Requirement to Monitor Environment ISO 17025 related Discussions 10
T Exxon - Environment Information - Climate Change - Wait and see (June 2017) Miscellaneous Environmental Standards and EMS Related Discussions 7
E Rich O2 Environment Testing Laboratories (Clause 11.2.2 ME EQUIPMENT and ME SYSTEMS) IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
M Process Capability in a High Precision Environment Capability, Accuracy and Stability - Processes, Machines, etc. 7
L How to Introduce the Quality Function to the production floor in a bad environment Misc. Quality Assurance and Business Systems Related Topics 6
Q What to consider in 6.4 work environment? ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
T EMC for Medical Devices in Home Environment Other US Medical Device Regulations 4
N Work Environment - ISO 9001 Clause 6.4 vs. OSHA Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
V Open vs Closed Systems - Criteria for Categorization in cGMP Environment Qualification and Validation (including 21 CFR Part 11) 4
R QA department in a manufacturing environment Manufacturing and Related Processes 6
G Assessment Form for Workspace & Workplace Environment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Digital Signature Solutions acceptable to use in an FDA Medical Device Environment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Clean Room as a Controlled Environment - Requirements ISO 13485:2016 - Medical Device Quality Management Systems 12

Similar threads

Top Bottom