This document does not include requirements for performance or functional characteristics of equipment. This is a product safety standard that classifies energy sources, prescribes safeguards against those energy sources, and provides guidance on the application of, and requirements for, those safeguards. The prescribed safeguards are intended to reduce the likelihood of pain, injury and, in the case of fire, property damage. This third edition cancels and replaces the second edition published in
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In a move that keeps things simple for product vendors, regulators in the US and EU have decided to harmonize the date the new standards will supplant the outgoing and standards. This harmonized date is now December 20, , giving vendors a unified target to focus their regulation compliance efforts in two of the most important worldwide markets. This positive development has come about as the EU has extended the date for "cessation of presumption of conformity" for existing products already tested in accordance with the old standards.
This cessation was originally scheduled for June 20, , although the date of withdrawal for EN and EN had been set for December 20, By consolidating these two events on the date, the EU can avoid allowing any unintended exceptions.
The situation is unambiguous now: on December 20, , the old standards will be withdrawn, and any product covered by the scope of EN the IEC standard as written into law by EU legislators must be tested in accordance with that standard.
Therefore, this is the date everything will change. And as the rule-makers have harmonized across the waters, OEMs get a little more time to put their new testing procedures and documentation in place.
All along, the standards bodies have been clear that is not intended to unify the preceding standards. The scope is the same, but the IEC technical committee responsible — TC — has used a substantially different standards-making philosophy that aims to create a less prescriptive, more future-proof document that helps create safer products for end users.
HBSE shifts the emphasis away from demonstrating that prescribed specifications have been met and requires product manufacturers to demonstrate that known hazards have been considered and the product has been designed to be safe to use in the expected context. However, despite being hazard-based, standards like do not require risk analysis in the same way as a standard like IEC HBSE principles work to protect equipment users by identifying any potentially hazardous energy sources and the mechanisms by which the energy could transfer to a user, while proposing suitable means of preventing those transfers from happening.
The scope includes normal operation and fault conditions. Importantly, HBSE also measures the effectiveness of the safeguards. These diagrams explain the idea more clearly: The HBSE three-block models used to analyze energy classes, transfer mechanisms and safeguards In the standards, energy levels that the user could be exposed to are categorized as ES1, ES2, and ES3. ES1 is the lowest category, as described in the table.
A similar rising scale is applied to analyzing electrical-fire hazards and means of prevention. Energy Source.
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IEC System of Conformity Assessment Schemes
UL/IEC 62368-1 專區