As the manufacturer needs to submit the technical documentation for the EU type examination (Annex III RED module B No. 3c) in order to market his product in the EU. The technical documentation must include an adequate analysis and assessment of the risk(s). The risk assessment is required without exception, even if harmonised standards have been applied. That is because a harmonised standard cannot cover every risk for every product. For example take the intermodulation of multiple transmitters. The manufacturer needs to document the assessment of how they are addressing the identified risks with regard to foreseeable use.
The risks assessment on the products is carried out during the product design by the manufacturer. Its a process that is best described by the manufacturer as he has the most knowledge on the product designed. He needs to take the necessary measures to reduce the risks of his product.
The purpose of the assessment is to identify the essential risks of the product, including electrical, chemical, mechanical, radiation, thermal, fire, spectrum, environmental, etc.. in normal and abnormal conditions.
Steps to take when doing a risk assessment
Doing an assessment of risks from the characteristics of the device and from the intended and foreseeable use or misuse of the device, you need to take care of the following steps:
- Search for harmonised standards or other specifications to minimize the risks
- Search for open risks which are not described in harmonized standards
- Use standards or other ways to mitigate risks
- Additional testing/assessment of open risks, if required
Probably most risk items are already covered by Harmonized Standards. Hence the risk assessment should especially focus on the possible risks not already covered by the Harmonized Standards, i.e. other possible unforeseen issues (due to combining radio with non-radio products) that might form a risk.
How to construct a good risk assessment
The risk assessment should focus among others on health, safety, spectrum and environmental risks.
Depending on which scope, at least you should make sure the following items are covered on your risk assessment:
- Risk (Hazards) Identification: Identification of hazards / risks
- Risk Occurrence Probability: Define potential harm & define probability of harm occurring.
- Risk categorization: Categorize the risk (for example Low, medium, High. Or any other rating scale based on severity and probability)
- Risk control measures: Based on categorization, control measures need to be defined to keep risks minimized.
Examples of risks to consider
For the RED you can think about the following risks to consider for your device:
Article 3.1(a) – Health / Safety:
- Risks due to harm to humans or animals related to sharp edges and corners.
- Risks due to Acoustic sounds, Excessive sound volume may damage the hearing of the user.
RF Exposure (SAR / MPE)
- Risks due to Radiator operational distance to human
- Risks due to Radiation to human/animals, generate radiation causing
- higher level of RF exposure.
- Risks due to electric shock, connecting the device with improper grounded equipment
- Risks due to energy related hazards
- Risks due to heat related hazards, High temperature environment or intensive sunlight can raise the heat of the device.
- Risks due to mechanical Strength
- Risks due to chemical hazards
Article 3.1(b) – EMC
- EMI and EMS issues, accessories
- Are EMC seals likely to last the expected life of the product?
- Are cable runs and cable position important to maintain performance? If so are the production drawings sufficient to detail construction?
- Are earthing arrangements, which are important for EMC performance, sufficiently detailed in the production drawings?
- Are components, which are important for EMC performance, sufficiently detailed in the production drawings?
- Can normal functioning of the product be disturbed by ESD.
- Can normal functioning of the product be disturbed by receiving interference from other electronic/ electrical equipment.
- Can normal functioning of the product damage other electronic devices. Some equipment are vulnerable to interference caused by the device.
- What frequency range has the product been tested over? Consider the range of clock frequencies used within the product.
- Are the technologies within the product likely to cause EM disturbances below the lowest frequency of test on the power cable?
If the product has ‘other’ ports (i.e. other than power), have they been tested? If not, are they likely to cause radiated disturbances due to their length? What efforts have been taken by the manufacture to mitigate this? - Does the product have telecom cables? Has testing been performed on these ports? If not, why? Is the mitigation reasonable under foreseeable circumstances?
- Are the technologies within the product likely to cause EM disturbances above the highest frequency of test? Consider the operating frequencies of the product and what communication services should be protected (note many product standards now require testing to 6 GHz due to the multitude radio services in the band 1-6 GHz).
- Are there any other unique factors within the product that should be considered (intentional radiators, but not radio communications, which are not covered by ISM frequency bands for example)?
- Are the immunity levels appropriate for the EM environment? Are there ports on the product which are liable to be susceptible and haven’t been tested?
Article 3.2 – Spectrum
- Transmitter power, essential requirements of the use of radio spectrum efficiency.
- Radio spurious emission, essential requirements of the use of radio spectrum efficiency.
- Harm to the radio spectrum.
Operational Environment
- Risks due to operational temperature
- Risks due to operational humidity
- Ideal storage temperature
- Usage in extreme conditions.
- Usage with not inbox accessories, usage of incorrect accessories may result in safety/EMC issues.
- Water areas, water or any other liquid may cause a short circuit and damage to the device.
- Pressure, excessive pressure to the device could crack the device and may also injure the user.
- Road safety, distraction while driving a car can lead to car accident and results in injury or death.
Production & Change Control
- Are there any critical manufacturing stages during in the production process that may lead to a degradation of EMC performance?
- Due to the construction of the product, are there any end of production line tests or inspections required to ensure EMC performance – if so please detail?
- Does the change control process ensure that any EMC performance critical components and constructions cannot be altered?
- Is production process standard to ensure product consistency.
Other
- Device reliability (drop test)
- Integration of module(s): Cover possible risks of integration of module(s) in a host (explain why initial certification of the module(s) can be reused when integrating this module in a host). Further supplying Module specifications and allowed (tested) host configuration.
Information requirement
- Is there adequate operational information to the end user.
- If product is supplied as components, sub-assemblies or subsystems which do not constitute a complete product. Are the instruction for installation and use adequate for the end user given in installation manual. Or is there a declaration of the module vendor, or a clear notice on the module certificate.
- User misuse the device Misuse the device may result in unexpected hazards.
Need help with the risk assessment?
Please let us know if you need any support with setting up the risk assessment.