Monday, February 28, 2022

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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Saturday, February 19, 2022

IEC 60601-1 Definitions

Hi friends!!!

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

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.

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

Let's get into the topic.

IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance

IEC 60601-1 is the parent of a series of standards relating to the safety of medical electrical equipment. The series also contains:

Collateral Standards

The Collateral standards are indicated by IEC 60601-1-NN which specify additional requirements covering specific aspects, Example: IEC 60601-1-6 covers Usability, IEC 60601-1-2 encompasses electromagnetic compatibility (EMC) issues of electrical medical devices.

Particular Standards

The Particular standards are indicated by IEC 60601-2-NN which specifies safety requirements for specific types of medical electrical equipment.

Performance Standards

The Performance standards are indicated by IEC 60601-3-NN which specifies performance requirements for specific types of medical electrical equipment. There are currently no performance standards that are in effect.

HISTORY

1^st Edition of IEC 60601-1 was published in 1977.

2^nd Edition of IEC 60601-1 was published in 1988.

3^rd Edition of IEC 60601-1 was published in 2005.

Edition 3.1 was released in 2012.

Edition 3.2 was released in 2020.

DEFINITIONS

MEDICAL ELECTRICAL EQUIPMENT

Electrical equipment having an Applied Part or transferring energy to or from the patient.

MEDICAL ELECTRICAL SYSTEM

Medical Electrical System is a combination of equipment of which at least one is classified as Medical Electrical Equipment and is specified by the manufacturer to be connected by functional connection or use of a multiple portable socket outlet.

APPLIED PART

The Applied Part is a part of Medical Electrical Equipment that in normal use necessarily comes into physical contact with the patient.

F-TYPE APPLIED PART

Applied part which is electrically isolated from earth and other parts of the medical equipment (Floating). F-Type applied parts are either type BF or type CF Applied parts.

TYPE B APPLIED PART

Applied part complying which specified requirements for protection against electric shock. Type B Applied parts are usually Earth referenced. Type B Applied parts are not suitable for direct cardiac application.

TYPE BF APPLIED PART

F-Type Applied part complying with a higher degree of protection against electric shock than type B Applied parts. Type BF Applied parts are those parts not suitable for cardiac application.

TYPE CF APPLIED PART

F-Type Applied part complying with the highest degree of protection against electric shock. Type CF Applied parts are those parts suitable for direct cardiac application.

ACCESSIBLE PART

Accessible Part is a part of electrical equipment other than an Applied Part that can be touched by means of the standard test finger.

BASIC SAFETY

Basic Safety is freedom from unacceptable risk directly caused by physical hazards when Medical Electrical Equipment is used under Normal and Single Fault Condition.

ESSENTIAL PERFORMANCE

Performance of a clinical function, where loss or degradation beyond the limits results in an unacceptable risk.

PATIENT CONNECTION

Patient connection means individual physical connections and/or metal parts intended for connection with the patient which form (part of) an Applied Part.

PATIENT ENVIRONMENT

Patient Environment means a Volumetric area in which a patient can come into contact with medical equipment or contact can occur between other persons touching medical equipment and the patient, both intentional and unintentional.

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