Staying up to speed with fast changing regulations is a major challenge for those sourcing power supplies. Here, Sager Electronics highlights some of the most recent updates.
One of the biggest challenges facing power supply purchasers today is keeping up with ever-changing regulations, at both the system and power supply level. Although many regulations affect the AC/DC power supply market and the products they power, there are a few standard requirements customers should be aware of before placing an order.
Safety certifications
The safety certification revisions for both medical (IEC60601-1) and information technology equipment (IEC60950-1) have gone to the next revision level. This means third edition for medical and second edition for ITE type systems. The adoption dates for these revisions varied by country and in some cases changed before actually going into effect, causing confusion. There are also still some countries that will only accept the second edition of the medical standard. These safety regulations continue to change as new amendments are added, which may require the system or power supply to be re-evaluated to confirm compliance with the most current certifications.
EMC requirements
The EMC requirements for medical systems (IEC60601-1-2) have also gone up a revision level to fourth edition. The original US implementation date was scheduled for April 2017, but has been pushed out to December 2018 to coincide with the European implementation. It applies to the basic safety and essential performance of medical equipment and systems in the presence and emittance of electromagnetic disturbances. This change is a system level requirement but is greatly influenced by the power supply. While a power supply can be verified on its own, it cannot be certified to the fourth edition requirement unless it is fully evaluated in the end system. Although the power supply is typically tested to verify compliance, there are interactions between the power supply and the end system that may cause system failure. Some tests require additional design work to account for these issues. Working with a qualified power specialist early in the process will help to minimize the impact and possible delays to the release of the system.
Addressing adapters
When purchasing external power supplies, or adapters, there are new energy efficiency requirements to consider. DoE Level VI, EU CoC Tier 1/Tier 2 have raised the average efficiency requirements while lowering the amount of power that can be consumed in a no-load condition where nothing is connected to the output of the power supply. It has also expanded the types of power supplies that must meet these requirements including battery chargers, multiple output supplies, non-compliant power over Ethernet mid span supplies, and supplies with an output power rating greater than 250W. Any external power supply that does not qualify for an exemption under these new regulations must meet the Level VI average efficiency and no-load power consumption requirements to be shipped into or sold in the United States.
Shipping to Europe
Products shipping to the European Union must comply with the restriction of substances of very high concern directive in EC 1907/2006 under the registration, evaluation, authorization, and restriction of chemicals program regulated by the European Union. There are currently 173 chemicals on the SVHC list, with four new chemicals added in January 2017. Chemicals are continuously being evaluated to determine their effect on human health and the environment. To comply, the power supply or system must contain less than 0.1 per cent by weight of each chemical. Those who import products into the European Union are responsible for fulfilling these requirements and they will require proof of compliance down to the smallest component within the system.
Working with distributors can help power supply purchasers keep up with these changing regulations, ensuring the products they choose support compliance, rather than causing more issues down the line.