Classes and Applied Part IEC60601 Electromedical Equipment

#1
First of all, I would like to thank you for being able to participate in the forum.

This is my first post and my question is as follows.

I work in the development of electromedical equipment for the aesthetic, dental, medical and related areas.

In the company we basically have Class II equipment, but I would like to know what is the difference between Class I and Class II equipment?

On the applied part we have in the IEC 60601 standard types B, BF and CF.

An equipment that has contact with the patient through a luminous applicator that contains an acrylic body that is in contact with the patient, what type would it be?

An equipment that has an applicator that contains metallic electrodes that come into contact with the patient, but insulated by a transformer that guarantees isolation between the patient and the input of the equipment, what type would this equipment be?

A surgical lighting equipment that is only wearable by the operator, what type would this equipment be?

I appreciate if you can help me.
 
Elsmar Forum Sponsor

Benjamin Weber

Trusted Information Resource
#2
Class I describes ME equipment, where the protective earth conductor (PE) is used as a means of protection against electric shock. Ususally such devices have metal accessible parts (enclosure, screws, grips...) which are connected to the PE. In the case of a hazardous voltage coming in contact to these parts, the fuse of the building installation will operate and avoid the electric shock to the operator/patient. Here you just need one additional means of protection, to be safe in the single-fault-condition of an interrupted PE. This is done trhough air clearances (AC), creepage distances (CD) and/or soild insulation.

Class II describes ME equipment, where the PE is NOT used as a means of protection. In this case you have to implement two means of protections by AC/CD and/or solid insulation in order to achieve double or reinforced insulation. Class II devices can have a so called functional earth conductor as third concdutor in the mains supply cable. But this is considered to be interrupted also in normal condition.

The applied part classification depends on the type of contact to the patient:

Applied parts with a conductive contact that is needed to fulfill its clinical function will be "BF". The applied parts are defined by a path where current can or shall flow to/from the patient. Electrodes are the standard example. If the electroded are intended to be used close the heart, they should be "CF". Applied part which have only a mechanical function are "B" (patient support etc.).

Your luminous adapter could be "B", but due to the electrical circuits quite close the the patient, they could by "BF" too. The acrylic body could serve to fulfill the "BF" insultation requirements (2 MOPP for max. amins voltage vs. mains part, 2 MOPP to secondary voltages, 1 MOPP to max. mains voltage vs. all other parts (PE, other applied parts...)).

The electrodes applied part should be "BF" or maybe "CF". The transformer will give you 2 MOPP for max. mains voltage vs. the mains part. But you have to have the additonal 2 MOPP for secondary and 1 MOPP for max. mains voltage vs. all other parts.

The lighting equipment that is worn by the operator only maybe doesn't even have an applied part, so no classification is needed (it is still within the scope of IEC 60601-1, since it transfers some energy to the patient).

IMPORTANT: Many collateral (60601-1-xx) or particular standards (e.g. 60601-2-xx / 80601-2-xx) explicitley require certain classifications!
 
Thread starter Similar threads Forum Replies Date
Y UL 1998 Standard: software classes Software Quality Assurance 2
S Where to get online AS standard audit certification classes? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
B Classes/ Online Training on ISO 13485:2016 and FDA QSR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 5
S Does IEC 62304 require documenting unresolved anomalies for all safety classes? IEC 62304 - Medical Device Software Life Cycle Processes 4
J One Medical Device, two indications, two classes, one technical file? EU Medical Device Regulations 4
H I've been asked to look for PPAP Classes Training - Internal, External, Online and Distance Learning 3
M Does anyone have a breakup of Establishments based on Device Classes ? Other US Medical Device Regulations 1
N Improving my Quality Qualifications - What certifications, seminars, classes, etc. Career and Occupation Discussions 2
K AATT 9101E/9101:2014 - Suspension of all AATT 9100,9110,9120 classes and examinations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A Two Identical Medical Devices put in different Classes - Class I and Class II 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Copying pages of the standard for internal audit training classes IATF 16949 - Automotive Quality Systems Standard 11
J Classes for Hydraulic Calibration - Dead Weight Tester or Automated Controller General Measurement Device and Calibration Topics 1
F Standard Classes for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 3
M CQE Preparation - Classes offered by ASQ or QC Group Professional Certifications and Degrees 9
D How to determine the Calibration/Test Weights with their classes General Measurement Device and Calibration Topics 5
C Furnace Classes in relation to AMS 2750 to determine Calibration Interval Calibration Frequency (Interval) 2
E Medical Device Classes IIa and IIb in EU and Australia Other Medical Device Regulations World-Wide 2
D Any MSA (Measurement Systems Analysis) classes in the Chicago area? Training - Internal, External, Online and Distance Learning 1
P APQP Training Classes in the Los Angeles, California area Training - Internal, External, Online and Distance Learning 4
L The value of Philip Crosby Associates classes like PONC and CCO, etc. Philosophy, Gurus, Innovation and Evolution 14
V Classes to take for AS9100 around the Fort Worth, TX area Training - Internal, External, Online and Distance Learning 1
F Certifying for Calibrations of Network Analyzers - Looking for classes/training General Measurement Device and Calibration Topics 1
T Free training - Adult classes for men Coffee Break and Water Cooler Discussions 34
ScottK How do you handle dozers in your training classes? Training - Internal, External, Online and Distance Learning 32
Govind Metrology Laboratory 'Classes' - Atmospheric, Ergonomic and Other Factors to consider General Measurement Device and Calibration Topics 6
L Classes offered for training on composite quality assurance and inspection? Training - Internal, External, Online and Distance Learning 2
V METER CLASSIFICATION - Accuracy values of the various classes of meters General Measurement Device and Calibration Topics 1
E Biocompatibility testing of our applied part seems redundant Other Medical Device Related Standards 2
A APPLIED vs ACCESSIBLE PART IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
R Flammability requirements for applied parts as per 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
G GD&T applied to reference dimension. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
A Dielectric withstand of applied part IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
S Defibrillator Protection applicability When using Multiple applied parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
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 13
N BF-type applied part MOPP vs secondary IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
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
Q Do you classify applied parts? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
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
Al Rosen 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

Similar threads

Top Bottom