Hi friends!!!

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

IEC 60601-1 Definitions

IEC 60601-1 Classification of Medical Electrical Equipment

IEC 60601-1 General Requirements for Testing Medical Electrical Equipment

IEC 60601-1 Medical Electrical Systems

IEC 60601-1 Protection against unwanted and excessive radiation hazards

IEC 60601-1 General Requirements

IEC 60601-1 Programmable Electrical Medical Systems 

IEC 60601-1 Hazardous situations and fault condition

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 Clause 15: Construction of Medical Electrical Equipment as per IEC 60601-1.

Let’s get into the topic.

Clause 15 – Construction of Medical Electrical Equipment

 

The Clause 15 of IEC 60601-1 states the requirements for Construction of Medical Electrical Equipment. The following are the Sub-Clauses.

Arrangements of controls and indicators of Medical Electrical Equipment

Serviceability

Mechanical strength

Medical Electrical Equipment components and general assembly

Mains Supply Transformers of Medical Electrical Equipment and transformers providing separation

Let’s discuss in detail about Important requirements of above-mentioned Sub Clauses.

Serviceability:

The Parts of Medical Electrical Equipment which are likely to be replaced or adjusted due to electrical, mechanical wear and environmental degradation or ageing shall be located and secured in an appropriate position which allows inspection, servicing, replacement and adjustment without damage to the nearby parts or wiring.

Mechanical Strength:

The Medical Electrical Equipment or its parts shall have an adequate mechanical strength which prevents it from having a loss of basic safety and essential performance. The adequacy of Mechanical strength is determined by the application of following tests based on the Medical Electrical Equipment Type.

 

Hand-Held Type 

Push Test

Drop Test

Molding stress relief Test

Body Worn & Portable Type

Push Test

Impact Test

Drop Test

Molding stress relief Test

Mobile Type

Push Test

Impact Test

Rough handling Test

Molding stress relief Test

Fixed or Stationary Type 

Push Test

Impact Test

Molding stress relief Test

Medical Electrical Equipment components and general assembly:

 

Construction of connectors

The Connectors of Medical Electrical Equipment shall be designed in such a way that the incorrect connection of accessible connectors and the removal of connectors without the use of tool shall be prevented.

Temperature and overload control devices

Over current releases and thermal cuts outs shall be independent and non-Self resetting.

Batteries

The incorrect polarity of the battery connection shall be prevented. The housing of the battery shall be properly ventilated to allow gases which produced due to charging and discharging of batteries to pass through.

Indicator

There shall be indicator lights to indicate that the Medical Electrical Equipment is ready for normal use. There shall be an indicator to indicate that the output exists for the Medical Electrical Equipment, in cases where the accidental or prolonged operation of output circuit might lead to a hazardous situation.

Actuating parts of controls of Medical Electrical Equipment

All actuating parts of the Medical Electrical Equipment shall be adequately secured such that they cannot work loose or pulled off during the normal use.

All rotating or movable parts of controls in Medical Electrical Equipment shall be provided with stops of adequate mechanical strength to prevent it changing from Maximum controlled parameter to Minimum controlled parameter or vice versa.

Cord-connected Hand-Held and foot-operated control devices

When placed in an abnormal position, the Hand-Held and foot-operated control devices shall not present any unacceptable risk due to change in their controlled settings. The foot operated control devices shall be designed in a manner to support and withstand the weight of a adult human.

Mains Supply Transformers of Medical Electrical Equipment and transformers providing separation:

In the event of short circuit or overload of any output winding, the transformers of Medical Electrical Equipment shall be protected from Short Circuit & Overload. The transformers shall undergo short circuit Test, Overload Test & Dielectric Strength test as per the requirements of IEC 60601-1.