For many years AV and ITE products have been introduced to the market place at an ever increasing pace and technologies used to produce them have been converging. IEC TC (Technical Committee) 108: Safety of electronic equipment within the field of audio/video, information technology and communication technology, which prepares the separate IEC 60065 and IEC 60950-1 series of safety standards for AV and IT equipment, felt it necessary to create a "hazard-based" standard, which would cover both. This led to the development of a new International Standard, IEC 62368-1, Audio/video, information and communication technology equipment - Part 1: Safety requirements, published in January 2010. This standard has gained wide acceptance in many markets where national versions have been published, such as CSA/UL 62368-1 in Canada and the US.
TC 108 experts feel that there are certain misconceptions regarding IEC 62368-1 and that it is important to dispel these by answering a number of questions.
HBSE (Hazard-based Safety Engineering), a safety science discipline that has been formalized over the last 15- 20 years, was used as a principal methodology in developing IEC 62368-1. As a result it is often characterized and referenced as the HBS (Hazard-based Standard), leading some incorrect conclusions to be drawn:
- IEC 62368-1 must be a generic HBSE standard;
- there must be some risk-based considerations associated with it, confusing the HBSE and Risk Analysis concepts;
- because of a. and/or b., the standard must not have requirements and compliance criteria that need to be met as with the traditional product safety standards for AV and ITE, for example the legacy standards IEC 60065 and IEC 60950-1.
What exactly is IEC 62368-1?
IEC 62368-1 is the latest safety standard for AV and ITE. It was developed by IEC TC 108 and is slated to eventually replace both IEC 60065 (safety of AV and similar electronic apparatus) and IEC 60950-1 (safety of ITE). Several national standards around the world have been published based on Edition 1 of IEC 62368-1, and it is expected that it will be more widely adopted by other countries and regions when Edition 2 is published later in 2013.
Two points are intended to be conveyed when IEC 62368-1 is characterized as the Hazard-based Standard:
- The standard was developed by IEC TC 108 as a new safety standard for AV, ITE and CTE (communication technology equipment), and HBSE was used as a principal methodology in its development
- For products covered under its scope, the standard lends itself to application using a hazard-based approach/process, i.e., (a) identify energy sources in the product; (b) classify the energy sources (effect on the body/on combustible material), e.g.: Class 1 (not painful, but may be detectable; ignition not likely), Class 2 (painful, but not an injury; ignition possible) or Class 3 (injury; ignition likely); (c) identify needed safeguards for protection from energy sources with the potential for causing injury or damage per the criteria in the standard; and (d), qualify the safeguards as effective using the compliance criteria (performance-based or construction-based (prescriptive)), also specified in the standard.
Merger of existing standards?
IEC 62368-1 is not a simple merger of IEC 60065 and IEC 60950-1; it is a new standard.
Over 10 years ago a decision was made within the IEC to develop a brand new standard for AV, IT and CT Equipment. This new standard was felt necessary because of the growing number of products then utilizing similar technologies, and having similar marketing/distribution channels, use environments and users. Obviously, this reality has become even more prevalent today.
Therefore, IEC TC 108 began to develop a brand new standard, with a foundation based on HBSE principles, research and field data, while also remaining aligned with IEC horizontal, basic safety and group safety standards.
Among the objectives adopted by IEC TC 108 from the outset was that the standard should be more performance oriented, but allow for prescribed constructions if they have a track record of being proven safe (for example, in IEC 60065 and/or IEC 60950-1). It should be technology independent as much as reasonably possible, and allow for more design freedom (again, by being based on sound engineering principles with compliance being more performance oriented). It should be applicable to a broad range of electronic products and allow for easier introduction of new technology to the global marketplace (and with minimization of national/regional differences). Finally, it should preserve information on the basis of (rationale for) requirements, and also be stable, understandable and user friendly, while leading to the design and manufacture of safe products.
The resulting standard was IEC 62368-1, and when all the above considerations are factored into it, IEC 62368-1 is viewed as a new standard and not a merger of IEC 60065 and IEC 60950-1.
Is IEC 62368-1 a generic HBSE standard?
No. IEC 62368-1 has a scope like traditional product safety standards, so it is not a generic HBSE standard that can be applied to any product, although many of its parts in principle could be applied elsewhere.
The requirements in IEC 62368-1 apply only to equipment covered by its scope (Clause 1), with examples of such equipment given in its Annex A. The examples provided in Annex A are aligned with the specific examples provided in the legacy standards, IEC 60065 and IEC 60950-1.
Also, while HBSE was used primarily to develop the requirements in the standard, and the standard is best applied using an HBSE application approach/process, it is not a generic (free-form) standard. It has both requirements and compliance criteria, some of which are performance-based and some of which are construction-based (prescriptive).
Does it contain specific requirements and compliance criteria?
Yes. IEC 62368-1 is a complete product safety standard with specific requirements and compliance criteria.
IEC 62368-1 has both stated requirements and associated compliance criteria, either performance-based or construction-based (prescriptive). In this sense the standard is no different to the legacy standards IEC 60065 and IEC 60950-1.
Is IEC 62368-1 compatible with the IECEE CB Scheme?
Yes. IEC 62368-1 is wholly compatible with the IECEE CB (Certification Bodies) Scheme and has a formal TRF (Test Report Form). Also it is compatible with related international safety mark certification services since, once again, there are specific requirements and compliance criteria that must be met in order to demonstrate compliance with the standard.
Is it a risk-based standard involving risk analysis on an individual product basis?
No. The use of IEC 62368-1 in a product evaluation does not involve risk analysis on an individual product basis. In a standard-writing context. HBSE does involve use of risk analysis to develop the specific requirements in the standard (for example, determining the limit values for a Class 1 energy source). However, this is done wholly as part of the development of the actual requirements by the involved technical committee, in this case IEC TC 108.
There is no risk-analysis involved in the application of the standard to individual products, either by the manufacturer or certifier. In this sense there is no similarity in intent or application to the IEC 60601-1 series of standards for safety of medical products, as some people have assumed.