Appliance and machine safety, risk analysis, and testing

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In determining the applicable health and safety requirements for an appliance or machine, it´s risks need to be analyzed. The results of risk analysis need to be considered in the design phase, manufacturing, usage, and foreseeable misuse. Risk analysis is carried out according to pertinent harmonized standards. For example EN ISO 12100 “Safety of machinery – General principles for design – Risk assessment and risk reduction“.

Risk analysis can reveal several hazards such as being crushed, cut, burnt, electrocuted, etc. Safety measures need to be taken to reduce these hazards to an acceptable level. Measures can be such as safety barriers, detection of people, body parts or objects, etc. The device`s safety functions have to reduce risk to a certain tolerable level with safety-related parts of the control system (SRP/CS) conforming to appropriate performance or safety integrity levels (PL or SIL). PL and SIL define the ability of safety-related parts of control systems to perform a safety function under foreseeable conditions.

In Europe, the manufacturer needs to adhere to pertinent directives such as the EU machinery directive, low voltage directive, electromagnetic compatibility directive, and the European Union’s harmonized standards. To indicate conformity to health, safety, and environmental protection standards the CE marking is needed in the European Union. If the appliance`s CE certification is conducted by the manufacturer or its representative it is assumed that the safety devices and emergency stop circuits used comply with the machinery directive and harmonized standards. Machinery SRP/CS is proven to achieve the designed performance level by the CE marking, certificate of conformity and validation of SRP/CS according to ISO 13849-2 Safety of machinery – Safety-related parts of control systems – Part 2: Validation.

The requirements for device safety are very strict in the EU and other developed industrial countries and the aim is to increase safety even more. There is a vast amount of partially overlapping and connected harmonized standards. Therefore a specialist is required to find the set of standards most suitable for a given device. Many new innovative machines do not have a directly applicable product standard that has a checklist for forseeable hazards. Therefore a specialist is required to determine all the hazards. To ensure that the product is competitive, reliable, and safe, it needs to be tested carefully in different scenarios and environmental conditions for a sufficient amount of time. This is especially important for gas, pressure, and electrical devices and for machines that pose a risk to persons, property, or the environment.

ET-Ex Machina has experience in: testing electrical and electronic devices and machines; risk analysis; safety calculations; assisting in achieving CE and UL/CSA certification. We have engineered automatic testing devices for electrical machines, electronics assemblies, and wire harnesses. We have the greatest work experience with standards EN 60335-1, EN 60204-1, EN 62368, ISO 12100, and EN 13849.

We can assist you in product certification according to CE or UL/CSA. If certification is requested by the client, we can assist also with the whole product certification by compiling a risk assessment according to EN ISO 12100 and calculating the required performance level of the safety systems. We can make measurements of electrical safety, rated power, cooling, test product functionality, software, reliability, IP classes, etc. We have a sinusoidal power supply to check current waveforms, rated power, and equipment temperatures at different frequencies and voltage limits.

If you are planning to develop or bring out a new device or machine and your product does not have the mandatory CE or UL/CSA certification or technical documentation, we suggest you contact ET-Ex Machina. We recommend to contact us in the early stages of your product’s development phase. Recalling and redesigning products to make them compatible with safety standards afterward can be very costly.

Be sure to contact us at, leave us your contact information and a brief description of your machine or device and requirements.

What is Risk Analysis?

Risk analysis is the activity carried out to determine the safety requirements applicable to equipment or machinery in accordance with the safety standard for machinery (ISO 12100) as well as other relevant standards. Risk is the combination of the severity of an accident or damage and the probability of its occurrence. The basic safety requirements for machinery and equipment are set out in the EU Machinery Directive (MD) and the Equipment Safety Act. The CE mark indicates that the product has been assessed by the manufacturer and meets EU safety, health, and environmental protection requirements. This requirement applies also to products manufactured outside the EU but marketed in the EU.

The risk analysis according to ISO 12100 first determines the limitations of the machine (use, time, space, environment, and foreseeable misuse). The potential mechanical, electrical, thermal, noise, vibration, radiation, material, and combined hazards are then assessed in all activities of the product life cycle, together with the severity of the worst consequences of possible accidents, the time of exposure, the likelihood of occurrence and avoidance. The result is the severity of the worst possible consequences of the accidents, S1 (scratch treated with first aid), up to S4 (death) with their risk classes CL4 to CL15. They determine whether the relevant risk (severity of the hazard or probability of an accident) needs to be reduced, how to do so properly, what the residual risk is, and whether it is tolerable with the necessary level of safety measures implemented.

The operation of the machine is then examined on a mode-by-mode basis, assessing what hazards may be present and identifying the risks without and with safety measures. This provides risk analysis files, performance level information needed to build a safety system, reliability calculations, and specific recommendations for increasing the safety of the device to the required level. In this way, the company has important inputs for compiling the safety part of the safety or operating instructions – the risk analysis of the machine or device is related to the technical file of the product, being one of its most important parts.