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.

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  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

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

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

3rd 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.