As a manufacturer, you may come across a lot of issues related to the design and construction of your products. So, to avoid such issues, you need to keep in mind the following:
Chemical, physical and biological properties
The design and manufacture of industrial products must be in accordance with the essential requirements of the relevant Directive(s). Attention should be given to the product’s properties, and in particular to the chemical, physical and biological properties. This means that:
- The materials used should be carefully chosen;
- There must be compatibility between the selected materials and the biological parts (cells, tissues, etc.);
- If the industrial product is intended to administer any medicinal products, it must be compatible with the legal provisions applicable to them;
- The type of materials, substances of gases the product may come into contact with should not affect its safe usability;
- Any substances, integral part of the product, should have verified usefulness. This means that the elements leaking from the product should be minimized and the risks associated with them reduced to the minimum;
- Control of the hazards associated with the transportation, storage and use of the product.
Construction and environmental properties
If the product you manufacture is intended to be used in conjunction with another industrial product or equipment, the entire combination, along with any connection system, must be safe for use and the specific purpose of each product, part of the whole, must not be affected or altered. The label should indicate any existing restrictions or they should be mentioned in the product’s manual. You should design and manufacture such complicated products in such a way as to remove or minimise:
- the risk of injury, which can be caused by their physical, dimensional and/or ergonomic features;
- risks associated with the environmental conditions (e.g. magnetic fields, temperature and electrostatic discharge);
- the risks of mutual interference with other products;
- any dangers that could be due to fire or explosion during normal use and in single fault condition;
- risks arising where maintenance or calibration is not possible (as with implants) from ageing of materials;
- the loss of accuracy of any mechanism with measuring and controlling functions through the ageing of materials;
Products with a measuring function
If the industrial product you manufacture has a measuring function, you must design it in such a way as to:
- take into account the intended purpose of the product;
- provide satisfactory accuracy and stability;
- indicate the limits of accuracy;
- ensure that the design of the measurement, monitoring and display scale is in line with present and applicable ergonomic principles;
- comply with the legal requirements of the relevant Directive.
Protection against radiation
You must design and manufacture your industrial product in a way that the radiation exposure of users is minimized without actually limiting its usage.
- Intended radiation - If the product is designed to produce hazardous levels of radiation, then it has to be possible for its user to control the emissions. In this regard, the product must be fitted with visual displays and/or audible warnings.
- Unintended radiation – The users’ exposure to the emission of unintended, stray or scattered radiation must be minimized.
- Operating instructions – The product’s instructions should contain detailed information regarding the radiation and its nature, how to protect the user against it, how to avoid misuse of the product and eliminate any inherent installation risks.
- Ionising radiation – If your product emits ionizing radiation, you must make sure that the quantity, quality and geometry of radiation being emitted can be changed and controlled.
If the product you manufacture is designed to be connected to one or more electrical sources, you must ensure that:
- If the users’ safety depends on an internal power supply, the product is equipped with a means of determining the state of that power supply;
- If the users’ safety depends on an external power supply, the product must be equipped with an alarm system which can indicate a power failure;
- All risks of creating electromagnetic fields, threatening the operation of other products, are reduced to a minimum;
- The continued reliability and performance of any incorporated electronic programmable systems is according to the intended use;
- If the product is meant to monitor clinical parameters of patients, it is equipped with an alarm system capable of alerting the product’s users of any situation threatening their life;
- The risk of accidental electric shocks during the product’s normal use and in single fault condition can be avoided as much as possible;
- It protects the user against mechanical and thermal risks.
You as a manufacturer must create instructions for use that contain the following:
- Your name (or trade name) and address;
- Details to identify the product and the contents of the packaging;
- The serial number of the product and its year of manufacture;
- Any special storage and/or handling conditions;
- Any special operating instructions, warnings and/or precautions to take;
- Product’s required performance and details of any side-effects;
- If the product is to be connected to another product, instructions on how to obtain a safe combination;
- Information that can be used for verifying that the product is properly installed and can function correctly and safety;
- Product’s maintenance instructions and details of calibration restrictions.
Manufacturer’s cleaning and sterilisation instructions
If the industrial product you manufacture must be sterilised before being used, you need to provide users with instructions for its cleaning and sterilisation that include:
- Full details of how to handle the product before using it;
- Where applicable, details of the nature, type, intensity and distribution of any radiation emitted for medical purposes.
If you manufacture industrial products, you may appoint any natural or legal person, located in the EU, to act on your behalf as an authorised representative. The authorised representative may be addressed by the authorities of the Member States instead of the manufacturer. The manufacturer remains generally accountable for actions taken by the authorised representative on their behalf.
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