KAN Report 9

	Standardization in the field of non-ionizing radiation, 11/2000, S. Eggert/A. Frosch/P. Schreiber (12 MB)
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Summary

In KAN Report 9, "Standardization in the field of non-ionizing radiation", published in November 1996, the Commission for Occupational Health and Safety and Standardization (KAN) published a summary of standards and regulations in the area of "electric, magnetic, and electromagnetic fields" and "optical radiation", drew attention to the associated problems, and described the remaining need for standardization.

Since the report was published, a number of new standardization projects have been launched, existing standards revised, and an important European Commission mandate published. The statutory provisions governing the application of non-ionizing radiation have also undergone substantial changes. On the one hand, the EC draft directive governing physical impact is not, in its present form, being pursued; on the other, the electrical engineering committee of the statutory accident insurance institutions (BGs) has since drawn up two new BG rules for the area of non-ionizing radiation, which have been published in draft form. Finally, the KAN Report has been instrumental in prompting standards committees to address known deficits in standardization and begin revision of the standards in the interests of occupational health and safety.

Four years after publication of the first edition, it would now appear appropriate to take these changes into account and to present the current state of standardization and legislation in the area of non-ionizing radiation. This objective formed the basis for the present revision and update. This report, like the first edition, consists of two sub-reports entitled "Electric, magnetic and electromagnetic fields" and "Optical radiation".

 

Summary of the study "Standardization in the field of non-ionising radiation"

Overview

1. The study describes the physical and biological evaluation basis in the areas of "electrical, magnetic and electromagnetic fields" and "optical radiation" and provides a detailed summary of the international directives, recommendations, standards and work items. In addition, it also lists the European and German regulations, standards and new proposals.
   
   
2. In the area of electrical, magnetic and electromagnetic fields, the directives, statements and recommendations published by ICNIRP form the basis for defining basic limit values in international and national regulations and recommendations. In most cases the derived limit values for direct and indirect effects published by ICNIRP are also adopted.
   
   
3. Regulations of IRPA and ICNIRP, the World Health Organisation WHO, ACGIH and the International Lighting Commission CIE exist for optical radiation. In the field of lasers, the international standard IEC 60825-1 has introduced safety classes that are today established throughout the world.   
   
   
   Analysis of the standards / work items
   
   
4.  The analysed standards / work items are each listed in tabular form in the Appendix of the two sub-reports and are commented about on the basis of conflicts with the European legal framework or the "German Consensus Statement" (GDS). In the field of "optical radiation", these are mainly documents of the IEC/TC 76 ("safety of optical radiation and laser equipment") and standards / work items in the field of lighting.
   
   
5.  To implement the Machinery Directive (98/37/EC), the three-part standard prEN "Safety of machinery – Assessment and reduction of risks arising from radiation emitted by machinery" has been elaborated by CEN under a mandate of the European Commission. The standard describes a procedure for estimating the risk arising from non-ionising radiation and defines categorisation of the machines. The limit values of the ICNIRP guidelines are used as reference values for the categorisation.   
   
   
   Area "Electrical, magnetic and electromagnetic fields"
   
   
6.  The IEC has decided not to define its own limit values for its international recommendations and to deal only with the measurement techniques for electrical, magnetic and electromagnetic fields. The IEC/TC 106 was founded for this work by agreement with CENELEC.
   
   
7. The European Commission has issued to CEN, CENELEC and ETSI a standardization mandate in the field of electrical engineering, IT and telecommunications. The aim of this mandate is to elaborate European standards under the Low Voltage Directive (72/23/EC) and the Telecommunications Terminal Equipment Directive (1999/5/EC) with requirements for the protection of persons against the hazardous effects of exposure to electromagnetic fields that can be generated by electrical equipment. The standards should define measuring procedures and limit values for the emissions of the equipment.
   
   
8. The national standards of the series DIN VDE 0848 were the first specifications for protecting persons against exposure to electromagnetic fields in which the entire frequency range of 0 Hz to 300 GHz was covered. Due to the fact that, on the basis of the European legal framework in the field of the health and safety of workers at work, exposure limit values are no longer defined in standards but in national laws, it was necessary to restructure and revise the series of standards. However, most parts have not yet been adopted as standards.  
   
   
   Area "optical radiation"
   
   
9. The conflicts with the European legal framework are explained using as an example the standard DIN EN 60825-1 ("Safety of laser products – Part 1: Equipment classification, requirements and user’s guide"; identical to IEC 60825-1) for a series of standards covering laser equipment and incoherent radiation sources.
   
   
10. The series of standards DIN 5035 and the European draft standard prEN 12464 define values for the minimum illuminance at workplaces. The national legal basis for this area are the Workplaces Ordinance and supporting Workplace Directives, as well as statutory accident insurance institution regulations that contain values for the minimum illuminance at workplaces and that are currently being revised. The study points out that the standards / draft standards in this area must be adapted accordingly.  
    
    
    Establishing the need for standardization
    
    Area "electric, magnetic and electromagnetic fields"
    
    
11.  The study identifies the following areas where there is a need for standardization:


• Determining emission parameters for electric, magnetic and electromagnetic fields on equipment, machinery and plant
• Measurement of basic and field values for real exposure
• Calibration of the measuring equipment currently used for these purposes and which is to be developed in the future
• Electromagnetic compatibility, as relevant to the functional safety, of medical equipment, systems and aids (active implants), whereby the EMC must be measured under conditions of real exposure, such as the operation of relatively strong sources in the immediate proximity (mobile telecommunication equipment).
• Properties, protective effect and monitoring of personal protective equipment against electromagnetic fields

In the study, these areas are stated more precisely and, in some cases, explained with the help of examples.


12. In the implementation of the standardization mandate described in Point 7, the emission limit values must be defined so that they make allowance for the respective conditions in which the equipment is used. If only the exposure limit values of the "Council recommendation of 12th July 1999 on the limitation of exposure of the general public to electromagnetic fields (0 Hz – 300 GHz)" are included in the standards, it remains questionable whether the equipment then designed conforms to the national health and safety regulations.
    
    
    Area "optical radiation"
    
    
13. In order to prevent future conflicts with the European legal framework in the case of new draft standards and revised standards of the IEC/TC 76, the study recommends that the areas 1. "Classification / product requirements" and 2. "Exposure limit values / company regulations" be regulated in different parts of standards. This would enable the parts of standards of the 1st area to be implemented unchanged on a European level, with the other remaining purely international if necessary.
    
    
14. There is an urgent need for standardization for defining procedures aimed at measuring and assessing exposure to optical radiation at workplaces. The results of the standardization work currently ongoing in the CEN/TC 169 should be carried over to the international level.
    
    
15. To date, no standards with classifications exist for products that emit optical radiation and which do not belong to the machines, laser equipment, LEDs or lighting units (e.g. ovens or disinfection equipment that emits thermal radiation). It would be desirable to also work out European standards for these products with class divisions based on the level of radiation emission.
    
    
    
    

KAN’s Recommendations

Overall assessment

The study explains the mechanisms by which non-ionising radiation has an effect and gives a comprehensive overview of the standardization in this field. The study reveals where standardization is required. It compiles a list of the standards documents that regulate areas concerning the health and safety of workers at work in which there is no provision for putting legal requirements into concrete terms via standards. This is of particular importance because the electrical engineering committee of the statutory accident insurance institutions has in the meantime formulated two new regulations for non-ionising radiation, which exist in draft form. These demand, among other things, the adherence to exposure limit values and the use of safety measures if it is possible that the limit values will be exceeded. This closes a regulatory loophole that was pointed out by the previous KAN study of November 1996.

The results of the study represent the current standardization status and should be forwarded to the occupational health and safety experts as soon as possible.

The need for statutory accident insurance institutions to act

1. The study shows where standardization is needed (see Part I, Section 7 and Part II, Sections 10.4 and 11). The statutory accident insurance institutions are requested to provide personnel and financial support to standardization projects in these areas.

The need for DIN to act

2. DIN and KAN are requested to find appropriate ways for an early exchange of information on exposure limit values in standards.

3. A mandate of the European Commission (see Part I, Chapter 5.1.2 of the study) states that limit values for the emission of electromagnetic fields should be defined in harmonised standards under the Low Voltage Directive and the Telecommunications Terminal Equipment Directive. DIN is requested to help ensure that these standards define measuring procedures that take sufficient account of the conditions under which this equipment is used. In addition, the emission limit values must not contradict already valid exposure limit values (see BGV B9 and B11).
   
   
4. Part II of the study (Appendix B) lists standards documents that regulate matters concerning the health and safety of workers at work and that contravene the "German Consensus Statement" (GDS) and / or the EU Memorandum on the "Role of standardization in relation to Article 118a of the EU Treaty". DIN is requested to inform the relevant standards committees about this and to make the study report available to the members.
   
   
5. DIN is requested to make efforts to ensure that company regulations and exposure limit values are taken from the series of standards IEC 60825 "Safety of laser products" or are at least regulated separately from the classification and product requirements in another part of the standard.
   
   
6. DIN is requested to continue supporting the standardization of processes for measuring and assessing exposure levels with respect to optical radiation at workplaces that has begun in the CEN/TC 169/WG 8, and to suggest to the standards committee that the elaborated standards be incorporated internationally, e.g. with the CIE (Commission Internationale de l’Eclairage).

The need for the KAN Secretariat to act

7. KAN and DIN are requested to find appropriate ways for an early exchange of information on exposure limit values in standards.
   
   
8. The study compiles standards documents that regulate matters relating to the health and safety of workers at work and that contravene the GDS or the EU Memorandum on the "Role of standardization in relation to 118a of the EU Treaty" (see Part II, Appendix B). On the basis of the study’s recommendations and taking into account the new BG regulations B9 and B11, the KAN Secretariat is instructed to comment on this.
   
   
9. The KAN Secretariat is requested to set down in an opinion specific change proposals for the series of standards IEC 60825 "Safety of laser products", about how company regulations and exposure limit values can be eliminated from these standards or at least be regulated separately from the classification and product requirements in another part of the standard.
   
   
10. On the basis of Prof. Reidenbach’s results, the KAN Secretariat is requested to address comments to the responsible standards committee to propose the redefinition of laser classes 2 and 3a in the course of revising IEC 60825-1, because the lid closure reflex does not always provide sufficient protection against lasers as defined by the present classes 2 and 3a.
    
    
11. The study points to areas in which there is a need for standardization (see Points 13 – 18 of the summary and the Study Part I, Section 7 and Part II, Sections 10.4 and 11) and names standardization projects already in progress (insofar as they exist). The KAN Secretariat is requested,

• to examine which new standardization projects (e.g. for heart pacemakers) can be initiated in the areas named and
• to monitor the standardization work already underway.

12. The KAN Secretariat is instructed to critically observe and, if necessary, comment on those standardization projects listed in Part II, Appendix C of the study for which it is presently not clear whether they contravene the GDS or the EU Memorandum.