Product standards and certification
October 2023

Many rules and standards govern the industry, and electronics is no exception.
Worldwide, over a million companies are certified ISO9001 for organization management.
IPC sets the standards and best practices for everything to do with production and, in some cases, design.
And the products themselves? These too must be certified before they can be marketed. We'll take a look at a few standards that are often unavoidable.
CE marking
The conditions for affixing the CE mark to a product are laid down in EU harmonization directives. CE marking guarantees that the product can be marketed without restriction within the EU (and the EEE). It offers consumers in this region uniform protection in terms of health, safety and the environment.
CE marking is not required in Switzerland. However, if Swiss sectoral legislation provides for conformity marking, CE marking may be used instead of Swiss marking.
Affixing the CE mark is the responsibility of the manufacturer or his authorized representative.
The conditions for affixing the CE mark to a product are laid down in EU harmonization directives.
FCC and UL: North American standards
In the USA, the FCC (Federal Communications Commission) is the competent body that sets technical rules and standards for various types of electronic equipment, including radio frequency devices, telecommunications terminals and industrial, scientific and medical equipment.
All specific regulations pertaining to these and other devices are contained in Chapter 47 of the Code of Federal Regulations.
Imported products are subject to stricter controls than domestic products. Chapter 15 of the same code sets out the details.
The RoHS directive
RoHS (Restriction of Hazardous Substances) is a European Union directive concerning electronics and the manufacture of electronic devices. It limits the use of ten hazardous substances, like lead, commonly found in electrical and electronic equipment (EEE).
The aim of the directive is twofold: to reduce pollution and prevent environmental damage caused by restricted materials, during recycling or waste disposal for example, but also to reduce the health risks associated with their exposure.
The RoHS directive applies directly to any company intending to sell, distribute or manufacture electronic and electrical products in the EU.
The RoHS2 revision has been in force since July 22, 2021. This new version extends its list of products to include phthalates ( present in certain cables and rubber) and encompasses industrial control and monitoring instruments as well as medical devices.
Technical product documentation must now be provided to supervisory authorities on request. Manufacturers' declarations of conformity (DoC) must specify whether exemptions apply to certain materials. Manufacturers, importers, agents and distributors must keep the technical documentation and the EU declaration of conformity for a period of ten years after the EEE has been placed on the market.
This list is far from exhaustive, and will depend on the product, its use and the markets in which it is sold.
From development to production, we'll advise you on how to proceed.