Monday, February 28, 2022

IEC 60601-1 Classification of Medical Electrical Equipment

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In our previous blogs, we have discussed about the following topics.


IEC 60601-1 Definitions


EU MDR Assessment Routes


EU MDR Timeline, Annex, Chapter


EU MDR Post Market Surveillance


EU MDR Clinical Evaluation


EU MDR Technical Documentation - Part 1


EU MDR Technical Documentation - Part 2


EU MDR General Safety and Performance Requirement


EU MDR Information on the Label


EU MDR Post Market Clinical Follow Up


EU MDR Unique Device Identification - Part 1 


EU MDR Unique Device Identification - Part 2


EU MDR Classification Rules


EU MDR EUDAMED


EU MDR Economic Operators


EU MDR Chapter & Articles - Part 1


EU MDR Chapter & Articles - Part 2


In today's blog, we are going to discuss about IEC 60601-1.


IEC 60601-1 states the Basic safety requirements for Medical Electrical Equipment's. Satisfying the requirements of IEC 60601-1 is an important task in order to commercialize the Medical Electrical Equipment's


Therefore, it is important for Medical Device QA/RA Professionals to know in detail about the  Classification of Medical Electrical Equipment as per IEC 60601-1.


Let's get into the topic.


CLASSIFICATION OF MEDICAL ELECTRICAL

EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS


As per IEC 60601-1 Section 6: Classification of Medical Electrical Equipment and Medical Electrical System, Medical Electrical Equipment’s are classified based on the following types.


Protection against Electric Shock

Protection against Harmful Ingress of Water or Particulate Matter

Methods of Sterilization

Suitability for Use in an Oxygen Rich Environment

Mode of Operation


Let’s discuss in detail about each of the above-mentioned types of classification

 

Protection Against Electric Shock

 

Medical Electrical Equipment having external power source are classified as Class I Medical Electrical Equipment or Class II Medical Electrical Equipment.

Other Medical Electrical Equipment’s are called as Internally Powered Medical Electrical Equipment’s

Internally Powered Medical Electrical Equipment, when connected to supply mains, will satisfy the requirements of Class I & Class II Medical Electrical Equipment. When not connected with the supply mains, it satisfies the requirements of Internally Powered Medical Electrical Equipment’s.

Protection against Harmful Ingress of Water or Particulate

Matter

 

Enclosures of Medical Electrical Equipment and Medical Electrical Systems designed to give a specified degree of protection against harmful ingress of water or particulate matter shall provide this protection in accordance with the classification of IEC 60529.


This classification will be IPN1N2.

N1 – Integer indicating a degree of protection against harmful ingress of Particulate matter.

N2 – Integer indicating a degree of protection against harmful ingress of water.

 

Methods of Sterilization

 

Medical Electrical Equipment and its parts can also be classified based on the method of sterilization intended in the instruction for use. Example: Ethylene Oxide Sterilization, Autoclave.

After sterilization, the Medical Electrical Equipment and its parts shall not have any signs of deterioration and unacceptable risk after dielectric test and leakage test.


Suitability for Use in Oxygen Rich Environment

Medical Electrical Equipment’s are classified to be used in Oxygen Rich Environment based on the following factors.

 

Risk of fire in Oxygen Rich Environment

The Risk of fire in an Oxygen Rich Environment can be reduced as far as possible under Normal Condition or Single Fault Conditions. An unacceptable risk of fire is considered to exist in an Oxygen Rich Environment when a source of ignition is in contact with ignitable material and there is no means that would limit the spread of a fire.

 

External exhaust for Oxygen Rich Environment

External exhaust outlets of an Oxygen Rich Environment shall not be located so that Risk of ignition occurs because of any electrical component mounted on the outside of the Medical Electrical Equipment. Oxygen concentration in the immediate surroundings of the electrical component shall not exceed 25 % under the least favourable conditions of operation.

 

Electrical Connection in Oxygen Rich Environment

Electrical connections within a compartment containing an Oxygen Rich Environment under Normal Use shall not produce sparks because of loosening or breaking unless they are limited in power and energy to the values.

 

Mode of Operation

Medical Electrical Equipment shall be classified based on Mode of Operation as Continuous Operation or Non-Continuous Operation.

If there is no marking in Medical Electrical Equipment, then it is assumed to be suitable for Continuous Operation.

The Duty Cycle will be indicated using an appropriate marking based on the maximum activation time (ON Time) and the minimum deactivation time (OFF Time), for Medical Electrical Equipment classified as non-continuous operation.


Now I hope you have acquired some knowledge about IEC 60601-1 Classification of Medical Electrical Equipment. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.


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