Product safety (LVD and MDR)

Product safety ensures the safety and health of consumers. Products placed on the market must comply with general and specific safety requirements.

Product safety

The most common product safety tests are:
– Insulation resistance
– Leakage current
– Capacitive discharge
– Push and drop tests
– Mechanical stability
– Mechanical impact
– Labeling
– User and technical manual

The BGEMC lab has the necessary infrastructure and expertise to execute these LVD and MDR tests.

Legislation

1. Europe
Before a product is placed on the European market the product must meet the essential requirements listed in the directives.

We can distinguish three directives:
1.1 Low Voltage Directive (LVD) applies when the product operates between 50 and 1000 Vac or between 75 and 1500 Vdc
1.2 R&TTE directive (Radio and Telecommunications Terminal Equipment) applies when the product uses wireless or “terminal” equipment.
1.3 Medical Device Regulations (MDR) applies to medical instruments, devices, material, …

2. United States of America
Not required for most devices but is possibly a customer’s requirement.

3. Canada
Not required for most devices but is possibly a customer’s requirement.
The BGEMC Lab can execute the LVD and MDR tests according to harmonised standards in order to prove that your product complies.

Applications

– Information Technology Equipment (ITE)
– Medical devices and appliances
– Laboratory and measuring equipment
– Automotive
– Agricultural vehicles
– Household
– Marine
– Wireless applications
– Military
– Aviation
– EV chargers
– …

Standards

The table below gives an overview of the standards according to which the BGEMC lab can test.
However, this is only a limited list. Do not hesitate to contact us for any specific question.

Infrastructure

– Leakage current test device
– Insulation test device
– Impact test device
– Test Probes
– Temperature measuring device
– Ball pressure test device
– Acoustic sound test device


Operating procedure
1. Full compliant testing
In case a product fails during the full compliant test an acceptable solution will be sought, possibly we can switch free of charge to pre-compliant testing.

2. Advice: In case more in-depth research is required the advice of an independent expert can be appealed to.

3. Pre-compliant testing
Appropriate for testing a prototype.
Tests are executed using the same calibrated equipment and by the same skilled test engineers.

Europe
Standard ID Description
EN 60335-1 + specific standards Electrical appliances for household and similar purposes
EN 60601-1 + specific standards Medical Electrical Equipment
Part 1: General requirements for basic safety and essential performance
EN 61010-1 + specific standards Safety requirements for electrical equipment for measurement, control and laboratory use.
Part 1: General requirements
EN 61851-1 + specific standards EV supply equipment for charging electric road vehicles, with a rated supply voltage up to 400 V AC and a rated output voltage up to 400 V AC.
Part 1: General requirements
EN 62368-1 + specific standards Information Technology Equipment
Part 1: General Requirements
Worldwide
Standard ID Description
IEC 60335-1 + specific standards Electrical appliances for household and similar purposes
IEC 60601-1 + specific standards Medical Electrical Equipment
Part 1: General requirements for basic safety and essential performance
IEC 61010-1 + specific standards Safety requirements for electrical equipment for measurement, control and laboratory use.
Part 1: General requirements
IEC 61851-1 + specific standards EV supply equipment for charging electric road vehicles, with a rated supply voltage up to 400 V AC and a rated output voltage up to 400 V AC.
Part 1: General requirements
IEC 62368-1 + specific standards Information Technology Equipment
Part 1: General Requirements