UPDATE 10/24/12: INFORMATION ABOUT INTERNATIONAL STANDARDS

The relevant ‘horizontal’ International Electrotechnical Commission (IEC) standards specifically for light-based devices which classify devices and stipulate general requirements are:

IEC 60601-1 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance)
IEC 60825-1 Ed 3 (Safety of laser products: Part 1 Equipment classification and requirements) – in development,
IEC 62471  (Photobiological safety of lamps and lamp systems) and
IEC 60335-1 (Household and similar electrical appliances - Safety - Part 1: General requirements)

as well as the corresponding ‘vertical’ IEC standards which specify the appropriate design, engineering, reliability, test methods, labeling and instructional controls:

IEC 60601-2-22 (Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment),
IEC 60601-2-57 (Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use) and the newly drafted:
IEC 60335-2-xx (Particular requirements for light-based cosmetic or aesthetic appliances for home-use) – in development.

The Working Groups (“WGs”) of the IEC Technical Committees (“TCs”) - TC76 WG1, WG4 and TC61 WG30 - have begun making progress on international standards for the laser and intense light products that are being marketed for skin treatments in the home (such as hair removal and skin rejuvenation). The home-use laser products have emission levels that would ordinarily result in their having laser hazard classifications of 3B or 4, but because of design features and interlocks, cannot emit hazardous radiation when the product is not in contact with the skin.

Because there is no outside emission, the control measures that the IEC 60825-1 standard specifies (Safety of laser products: Part 1 Equipment classification and requirements) do not make much sense. For this reason, IEC Technical Committee TC 76 WG1 has defined a new laser class, 1C in its draft revisions to IEC 60825-1. These draft revisions recognize that these products are already in the marketplace and that the Class 3B and 4 control measures do not make much sense for them. If this new classification is approved, at least one vertical standard will be needed to specify the appropriate design, engineering, reliability, test methods, labeling and instructional controls.

If international standards committees do not collaborate in the development of these standards, chaos will result, and whatever standards do come along will be those developed by competing manufacturers. In addition, some countries believe that such products are medical devices because they produce physiological changes in the skin. Some of these countries also have regulatory requirements for them as medical devices. Other countries treat these products as home appliances for consumer use.

IEC TC 76 has provided the necessary ‘enabling wording’ for Class 1C laser devices in its revisions to IEC 60825-1 and these revisions will go forward as a Committee Document for Voting during 2014.

NEW MDD INITIATIVE

The latest proposal (dated 29.09.2012) for a re-casting of the EU Medical Device Directive (MDD) defines on pages 28, 29 and 171 what a medical device is and gives examples of such devices, that may be relevant to manufacturers of laser and intense light devices. Essentially, the definition of a medical device being a device for the purpose of "modification of the anatomy or of a physiological process or state" is unchanged from the current 1993 MDD but now the new draft Annex XV specifies lasers and IPLs for the first time. The progress draft has a "subsidiary date" of 27.11.2012 and you can track its progress on the EU website:

http://www.ipex.eu/IPEXL-WEB/dossier/document.do?code=COM&year=2012&number=542&extension=null

GENERAL PRODUCT SAFETY DIRECTIVE (GPSD) NEWS

On 19th July 2012 the German Ministry (BMELV) wrote to the European Commission (EC) in Brussels objecting to the draft wording of the GPSD allowing Class 1C lasers to be sold “OTC” to end consumers. BMELV proposed to the EC that the use of lasers be restricted to use by medical doctors only, supported by an 11-year old document from the German Radiation Protection Agency (SSK) - which appears to have been translated into English for the first time for use here in support of the German proposals.

The intended laser Class 1C being developed in standards within IEC Technical Committees allows for lower classification of an "embedded" laser of a higher risk class to be employed in a consumer (or professional) device, providing that interlocks under single fault condition prevent hazardous light radiation leakage above the Accessible Emission (AE) limits for eye damage for a "safe" Class 1 laser.

A Meeting of the Committee of Directive 2001/95/EC on General Product Safety was held in Brussels on the 24th September 2012. A Draft Summary Record of the Meeting can be viewed at:

ec.europa.eu/consumers/safety/committees/docs/sum_24092012_gpsd_en.pdf

Item 11. Is quoted below:

It therefore remains unclear at present how the EC will move forwards on the German Ministry objection.

Generally, no such ocular hazard arises with home-use IPL (below Risk Group 1 in IEC60601-2-57) but higher Risk Group "embedded" IPL sources could conceivably be employed in home-use devices for certain applications (e.g. acne therapy). Therefore, intense light home-use device manufacturers should be especially vigilant about this proposal by BMELV being extended to IPL devices as it could stop current OTC sales of IPL devices as well as lasers in the EU if adopted.

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