Wrist Actigraph Device - IEC 60601-1 general questions

L

luisf.rossi

#1
#1
Hi,

We are certifying a wrist actigraph device and we have some doubts regarding IEC 60601-1 due to the simplicity of the device.

Should the electrical schematic be just a logical schematic or the real one with all electronic components soldered in the Main Board with PNs and values?

What is the detail level of the Critical Component List? Would be like: Battery, processor, accelerometer, memory? Or like electronic board?

How can I create an insulation Diagram? It is a battery powered device that is wrist worn ...

Thank you for the help.
 
Paper to QMS ad
Elsmar Forum Sponsor
M

Mark Meer

Trusted Information Resource
#2
#2
Could you site the 60601-1 clauses in question? I did a quick search of the standard for "schematic", "critical component" and "insulation diagram", and got no results....

By "Electrical Schematic", I presume you mean what is referred to as "Circuit Diagram" in the standard? If so, then yes, this will have to be the detailed version (the "real one") in order to be assessed properly.
(NOTE: except for the clause on servicing, 7.9.3.3, there is no other requirement that I can see for providing a parts list with part-numbers).

By "Critical Components", do you mean "Components with High-Integrity Characteristics" (IEC60601-1, 3.17 & 4.9). If so, the definition is in 3.17.
This can be easily interpreted as "everything", because nearly everything has a purpose, but I don't think this is the intent. Because the standard specifically says "...in relation to the safety requirements....", I think the intent is to identify the components that have non-negligible risk associated, or are themselves risk-controls, as would have been identified in your risk analysis documentation.

I have no knowledge of insulation diagrams, but again, doing a quick search, I can't see anywhere in the IEC 60601-1 standard calling for these...
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Crusader Ugh, broke my left wrist! Coffee Break and Water Cooler Discussions 14
L Calibration of ESD Wrist Strap Tester General Measurement Device and Calibration Topics 14
A How to determine an ESD wrist strap's life span? Misc. Quality Assurance and Business Systems Related Topics 5
M Tasked with Raising Quality Awareness - Metrics to apply - Identification wrist bands Quality Tools, Improvement and Analysis 4
J Meeting 100% compliance in wrist strap testing - ESD (Elecro-Static Discharge) Misc. Quality Assurance and Business Systems Related Topics 27
J 21 CFR 821 Medical Device Tracking Requirement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
N Drawing tolerance vs. Measurement device General Measurement Device and Calibration Topics 4
S Iraq Medical Device registration Other Medical Device Regulations World-Wide 0
R Medical Device Software Certification IEC 62304 - Medical Device Software Life Cycle Processes 1
D Medical Device Accessories Other Medical Device Regulations World-Wide 1
C GUDID Device record history Medical Device and FDA Regulations and Standards News 2
K Doubt on insulation class of a device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
dgrainger Informational UK guidance on Device regulation from Jan 2021 published EU Medical Device Regulations 7
dgrainger Informational UK guidance on Device regulation from Jan 2021 published Other Medical Device Regulations World-Wide 3
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
A First CE-mark class III implantable device under MDD EU Medical Device Regulations 8
M EU MDR - Labilities when a device is discontinued from the Market EU Medical Device Regulations 1
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
S Work performed in Canada on US patients using US device Canada Medical Device Regulations 1
T Clinical evaluation of a new medical device EU Medical Device Regulations 0
Beliz Biocompatibility Testing for Laser Epilation Device EU Medical Device Regulations 2
A Packaging device with accessories already on the market Other Medical Device Regulations World-Wide 0
7 Iraq Medical Device Chemical Regulations Other Medical Device Regulations World-Wide 0
J UCLA extension Medical Device Engineering Program Training - Internal, External, Online and Distance Learning 0
Q Storing and developing SAMD (Software as a Medical Device) in the Cloud IEC 62304 - Medical Device Software Life Cycle Processes 2
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
A How to make sure whether the predicated device is marked with EC certificate? EU Medical Device Regulations 8
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
O ANATEL certification of Medical Device Other Medical Device Regulations World-Wide 0
B MDR equvalent device - can you use a medicine as an equivalent 'device' EU Medical Device Regulations 8
Ajit Basrur FDA News Harmonizing and Modernizing Regulation of Medical Device Quality Systems (7-2020) US Food and Drug Administration (FDA) 0
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 1
A Legal Manufacturer Medical device US Food and Drug Administration (FDA) 2
D Device functionality over service life - Objective evidence required? Design and Development of Products and Processes 10
F How to register class I device to all European Competent Autorities(CA) when we are European manufacturer EU Medical Device Regulations 4
K Sterile barrier system symbols - Label redlines for a Class III device (Kit Box) EU Medical Device Regulations 0
D Class 3 Device - Change of supplier of material Canada Medical Device Regulations 6
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 3
K EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device; EU Medical Device Regulations 1
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
S Looking for Quality Content to Build Medical Device Curriculum - Concept to Commercialization Training - Internal, External, Online and Distance Learning 4
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Legal Manufacturer of a medical device Vs Legal Manufacturer of MDSW EU Medical Device Regulations 7
T Loaded spring device - Active medical device? EU Medical Device Regulations 1
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0

Similar threads

Top Bottom