Do you classify applied parts?

#1
Dear all,

Do you classify applied parts separately to the main ME Equipment? For an ultrasound machine, the applied part (i.e. the transducer) is commonly given a separate Ingress Protection score. Would you also be expected to classify this part as a hand-held and perform push, drop and moulding stress relief tests on it?

Thank you very much!
 
Elsmar Forum Sponsor

Benjamin Weber

Trusted Information Resource
#2
In the first section of 15.3 "Mechanical strength" it says "ME equipment or its parts".
And of course different parts of the ME equipment can be classified differently.
In your case: The ultrasound device itself would most likely be classified as portable or mobile (if it has wheels) and the transducers as hand-held. As a consequence, different mechanical strength tests are applicable for different parts according to table 28 of 60601-1.
 
Thread starter Similar threads Forum Replies Date
D Supplier Quality - How to classify a supplier level Medical Device and FDA Regulations and Standards News 10
B How to classify a medical device based on MDR? EU Medical Device Regulations 3
I How to classify a medical device based on FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
A Device Classification - India CDCSO - How to classify the device? Other Medical Device Related Standards 1
D Example for Accessories of "Annex XVI non-medical devices" and how to classify it now with respect ot EU MDR Other Medical Device Regulations World-Wide 1
O Which part of ISO 14644 describe how can I classify cleanrooms between them? Other ISO and International Standards and European Regulations 0
L How to classify this computer-alike IT device EU Medical Device Regulations 2
C How to Classify a Medical Device Other Medical Device and Orthopedic Related Topics 6
W Let's play... Classify My Medical Device!!! EU Medical Device Regulations 15
A How does Japan PMDA classify Medical Devices - Classification Guidelines Japan Medical Device Regulations 6
M Is it necessary to classify nonconformance as minor, major, observations in an IQA? Internal Auditing 18
E How do you classify Contact Lenses ? Non-invasive, Invasive or Surgically Invasive? Other US Medical Device Regulations 1
I How do you classify/name your CAR (Corrective Action) types? Nonconformance and Corrective Action 6
G How to classify maintenance level of equipments? Manufacturing and Related Processes 3
K Would you classify this as a concession? Document Control Systems, Procedures, Forms and Templates 5
A How many ways do you classify your scrap? Quality Tools, Improvement and Analysis 15
A 60601-1 : Integrated Dry ECG Electrodes = 2 Patient connections inside 1 applied part? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
C IEC 60601 - 8.8.3 Dielectric Strength test. 4kv being applied to the ground conductor?! IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Separation of F-type applied part and remaining parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
N BF-type applied part MOPP vs secondary IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Identifying Applied Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
T Single Fault Condition IEC 60601 Clause 8.7.1 shorting Cr/Cl in Patient Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
R Defib-proof applied parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
B ISO 14971 Applied to Software ISO 14971 - Medical Device Risk Management 2
M 2xMOPP insulation for Applied Part B. IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
A Technical File - Updating Applied Standards EU Medical Device Regulations 4
K Question on whether IEC 60601-2-62 standard is applied IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
J ISO 14971 applied to ISO 13485? Low risk class 1 devices ISO 13485:2016 - Medical Device Quality Management Systems 5
T Overvoltages consideration in Applied Part for RMS Calculation. IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
B F-type applied part - Separation from ALL(?) other parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
G ISO 9001 8.4 applied to 7.1.3 - Suppliers of infrastructure requirements - IT and Print solutions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
E Functional Gage for TOP applied at RFS Design and Development of Products and Processes 5
K F-TYPE APPLIED PART IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
J ISO 9001 8.4.1 - Determining controls applied to externally provided processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
T IEC60601-1: Isolation for an applied part with working voltage of 1500Vp. IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
L PC in patient environment - BF applied part that uses USB to connect to PC IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
N Applied Parts Classification Clarification - Breast Pump IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
E Are EEG electrodes considered as one applied part? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
H Defib Protected Applied Parts: 4mm clearance/creepage? IEC 60601 - Medical Electrical Equipment Safety Standards Series 14
S Number of MOPP for Type BF Applied Part (Medical Device Electronics) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Tagin Can/should SPC be applied to Computer Assembly and Software Imaging? Statistical Analysis Tools, Techniques and SPC 8
A EFQM applied on the ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
L No entanglement hazard of applied parts cables? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D NQA-1 Standard Applied to Services rather than Items for Nuclear Power Various Other Specifications, Standards, and related Requirements 3
S Internally powered ME with non-conductive applied parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K Can a Surface of a profile be applied to a feature of size? GD&T questions Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
S Oxygen mask and nebilzer mask Applied standards EU Medical Device Regulations 2
E Requirements for primary battery powered ME with BF-applied parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
P Identifying Medical Device Class and Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T Electrical Surgical Tool with Big Metal Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 5

Similar threads

Top Bottom