Product Safety Testing & Consulting


Medical key functions include input, storage, display,

process and output of data and of telecommunication



Test Methods Capabilities

Equipment are mainly covered by EN/ IEC 60601-1-2,

IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-9, IEC 60601-1-11,

IEC 60601-1-12, IEC 60601-2-2, IEC 60601-2-10, IEC 60601-2-18, IEC 60601-2-22,

IEC 60601-2-24, IEC 60601-2-27, IEC 60601-2-31, IEC 60601-2-34, IEC 60601-2-47,

IEC 60601-2-57, IEC 60601-1-1 (Amd.3.1).

The standard identifies higher level immunity requirements for life-supporting

equipment and lower immunity requirements for non-life

supporting equipment. 


Short Customer List

AliveCor, CarlZeiss Meditec, Channel Medsystems, Concensus,

Corinth Medtech, Eko Devices, GE Healthcare, K2 TABLES, Knox Medical,

MedFolio, Meditrina, Olympic ophthalmics, Owlet Baby Care, Peak Surgical,

PhysioWave, Medtronics, PCI, Precision Biopsy, Primaeva Medical, Propel Orthodontics,

Relign, RH USA inc, SANARUS, Seiler Instrument, Smart Vision Labs, St Jude Medical,

Techniquip, Terumo Medical, Tivic Health Systems, TransAct, Triple Ring technologies, Tesla

Vision Care Devices, Zuno.

Information Technology Equipment (ITE)

ITE key functions include input, storage, display,

process and output of data and of telecommunication

messages. ITE equipment is primarily covered by

IEC 60950-1 Information Technology Equipment – Safety 


The 60601 series of standards consists of 60601-1

and 60601-2-XX. Part 1 applies to all medical

products while Part 2 addresses specific requirements

for a particular type of medical device.

There are over 40 Part 2s


Audio/Video Equipment is covered be either the EMC

Directive or specific standards including IEC 60065

Audio, Video and Similar Electronic- Safety.


Environmental Safety standards cover hazards

resulting from a product’s exposure to extreme

environmental conditions. Typical environmental

tests include Temperature Testing, Humidity Testing,

Vibration and much more.

Industrial Equipment safety standards

Industrial Control Equipment can generally be

described as devices for starting, stopping,

regulating, controlling, or protecting electric

motors, devices that store or process information

and are provided with an output motor control

function(s) as well as industrial control panels.

These devices are primarily covered by

IEC 60204-1 and IEC 60529.

A broad range of product safety requirements exists in all major markets around the world. Specific safety standards vary depending on the type of product, the environment in which it is intended to operate, and the country where it is being sold. Product Safety Hazards include the following:

electric shock Hazards warning sign

Like the bird perched on a high- tension wire, the human body is immune to

shock so long as it is not part of the electrical circuit.

Voltages above 30Vrms or 60Vdc are considered hazardous.

Energy levels over 240VA or 8A are considered hazardous.

Electrical Safety standards cover hazards related to the product’s

usage of electricity. Four Tests are most commonly used to

verify electrical safety:

  • Line- Leakage
  • Insulation Resistance (IR)
  • Ground Bonding
  • Dielectric Withstand/ Hipot

Fire Hazards warning sign

Enclosures, components, and other parts shall be constructed such that

propagation of fire is limited. Flammability of enclosure, internal, and external parts shall be adequate for the use of that part.

external parts shall be adequate for the use of that part.

Mechanical Hazards warning sign

Mechanical Safety standards cover hazards related to the physical characteristics of the product, such as:

  • Product height and weight distribution (tipping hazards)
  • Sharp edges
  • Pinch points, including exposed roller mechanisms
  • Enclosure openings (risk of electrical shock, etc.)

Radiation Hazards warning signRadiation Hazard includes the following areas:

  • Ultraviolet
  • Laser
  • Sonic (audible noise)
  • Ionizing

Damage to the components in the equipment must be considered in

addition to hazards to the operator or service personnel.