AAMI Standard - 6 Foot Radius Patient Vicinity

Bunny

Quite Involved in Discussions
#1
Does anyone know the AAMI standards that addresses medical equipment within the 6 foot radius around the patient?
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Not the answer to the question you asked but IEC 60601-1 provides a bit of guidance. They say that it is "difficult" to define the dimensions but indicates that 1.5 meters away from any point in the environment has been "justified in practice." (So if a patient is laying on a table, the patient environment includes the complete table; i.e., so 1.5 meters away from any point on the table). I can see a number of difficulties trying to exactly specify.
 

Bunny

Quite Involved in Discussions
#3
I am not questioning the 6 foot perimeter. We are questioning the requirements. An inspector on site is asking for test reports for the monitors we provided, but he is not asking for the test reports for the desktop computer or monitor that is sitting on the nurses desk right next to the monitor for our medical device. What is the difference? We need to get our hands on the AAMI standard he is referencing his information from.
 
Thread starter Similar threads Forum Replies Date
M Informational From AAMI – FDA Recognizes AAMI Standard and TIR Medical Device and FDA Regulations and Standards News 0
N FDA standard approval list - ANSI/AAMI SP10 - 1992 revision approval ISO 13485:2016 - Medical Device Quality Management Systems 2
A ANSI/AAMI versions of 60601-1-2 and related testing requirements Other Medical Device Related Standards 0
S Medical Device Endotoxin Testing for ANSI/AAMI ST72:2011/2016 Other Medical Device Related Standards 1
I Certification CISS by AAMI - I want to form a study group Professional Certifications and Degrees 5
L Can anyone enlighten me on the use of AAMI HE-74? Other Medical Device Related Standards 6
M AAMI draft report - Postmarket Risk Management ISO 14971 - Medical Device Risk Management 2
M AAMI/ANSI 11135-1:2007, EO Sterilization Other US Medical Device Regulations 8
E Cleaning Validations for Reusable Products - ANSI/AAMI TIR30:2011 Requirements Other Medical Device Related Standards 3
M Differences between international and regional standards (EN, AAMI, CSA...) Other Medical Device Related Standards 6
A IEC/TR 80002-1:2009 vs. AAMI TIR32:2004 Other Medical Device Related Standards 3
S AAMI EC57 for ECG Medical Device - Seeking 3rd Party Test Laboratory US Food and Drug Administration (FDA) 5
E Does anyone have a good understanding of the application of ANSI/AAMI AT6? Various Other Specifications, Standards, and related Requirements 3
L AAMI TIR(SW1)/Agile Practices in the Development of Medical Device Software IEC 62304 - Medical Device Software Life Cycle Processes 8
D Independent Testing of ECG Electrodes in accordance with AAMI standards Reliability Analysis - Predictions, Testing and Standards 5
A Cons and Flaws in AAMI 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
S AAMI TIR28:2009 Product adoption & process equivalency for ETO sterilization Other US Medical Device Regulations 2
M Harmonization of ANSI/AAMI PB70:2003, EN 13795? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M ISO/ANSI/AAMI PB70:2003 and EN13795 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R IEC/AAMI/ANSI 60601-1:2005 Checklist IEC 60601 - Medical Electrical Equipment Safety Standards Series 16
P Has AAMI TIR 14969 (ISO TR 14969) been released for ISO 13485:2003? ISO 13485:2016 - Medical Device Quality Management Systems 2
N Ansi/aami/iso13485:2003 + Iso14971:2000 + Iec60601-1-4:2000 + Mdd93/42/eec IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
G Copy of withdrawn ISO 9001:1994 Quality Management Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Anonymous16-2 SOP (Standard Operating Procedure) Numbering Document Control Systems, Procedures, Forms and Templates 7
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3
Skooma Deburring and Tolerances - Is there a Standard for deburring or removing material? Manufacturing and Related Processes 3
B Purchasing AS9100D Standard in Japanese AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
O In addition to the standard, what other ISO 13485 sources do people recommend? ISO 13485:2016 - Medical Device Quality Management Systems 5
B ASTM E18-2020 - Rockwell testing standard changes? General Measurement Device and Calibration Topics 2
M Informational RoHS Standard - EN 63000:2018 to replace EN 50581:2012 Medical Device and FDA Regulations and Standards News 11
M IEC 60601-1 1988 - Device developed in 2012 with standard of 1988 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
P Cenelec updated standard information CE Marking (Conformité Européene) / CB Scheme 1
S Is there a standard for sample size during R&D phase Other ISO and International Standards and European Regulations 18
J Standard used to determine if check fixture gauge is acceptable Reliability Analysis - Predictions, Testing and Standards 2
N Program or application for standard time measurement in industry from video surveillance? Human Factors and Ergonomics in Engineering 1
I Where can I beg, steal (just kidding of course) or borrow good training material on the ISO 9001:2015 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Question on whether IEC 60601-2-62 standard is applied IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
B Clause 5.1.12 of Technical Standard IEC 62304/A1 IEC 62304 - Medical Device Software Life Cycle Processes 5
M Viable count Measurement ISO Standard Other Medical Device Related Standards 1
I When exactly was "competence" added to the ISO-9001 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S Managing specification changes on standard parts purchased through trading companies Document Control Systems, Procedures, Forms and Templates 2
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
S Average and standard deviation of Cumulative Data Statistical Analysis Tools, Techniques and SPC 5
R Standard Filter for Calibration Colorimeter ISO 17025 related Discussions 1
B Standard for Dielectric Strength Test IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Specific Absorption Rate (SAR) Testing - What Standard to Use? Other ISO and International Standards and European Regulations 1
M Harmonised RED Standard ETSI EN 440 - Which Version? Other ISO and International Standards and European Regulations 0
R QMS Standard appilications on different Defense Sector Quality Management System (QMS) Manuals 1
A Supplier Quality Standard vs Senior Management Direction Supplier Quality Assurance and other Supplier Issues 2

Similar threads

Top Bottom