rus
Issue #1/2014
B.Rakhmanov, Doctor of Engineering, V. Devisilov, A.Mitrofanov, V.Kibovsky
Issues of Technical Regulation of Safe Application of Laser Equipment Part II. Propositions on the Development of a New System of National Standards on Laser Safety
Issues of Technical Regulation of Safe Application of Laser Equipment Part II. Propositions on the Development of a New System of National Standards on Laser Safety
Measures for overcoming the existing legal collision in the area of laser safety are considered.
Measures for overcoming of the occurred legal collision in the area of laser safety (LS) were considered in the published work [1]. National standard ГОСТ Р ISO 11554 – 2008 "Optics and Photonics. Lasers and Laser Facilities (Systems). Test Methods of Lasers and Measurements of Capacity, Energy and Temporary Characteristics of Laser Beam" which is applied only with respect to the products intended for export is specified as an example. There are other standards which have analogous common standardization subject – for example, ГОСТ Р ISO 11146 applicable for any laser products (LPs) manufactured within the territory of the Russian Federation and intended for the domestic market as well as export. The standard consists of three parts. The first part of the document is called ГОСТ Р ISO 11146-1 – 2008 "Lasers and Laser Facilities (Systems). Measurement Methods of Width, Annular Divergence and Propagation Coefficients of Laser Beams. Part 1. Stigmatic (Homocentric) and Poorly-Stigmatic Beams". ГОСТ Р ISO 11146 standard is developed by the Federal State Unitary Enterprise All-Russian Research Institute of Optical-Physical Measurements (FSUE ARRIOPM) on the basis of its own authentic high-quality translation.
We suggest calling the main common standardization subject of standards project system on laser safety similarly – "Lasers and Laser Facilities (Systems)". We offer borrowing the name of the second common standardization subject – Laser Safety – from the following standards: ГОСТ 12.1.040 – 83 "System of Labor Safety Standards. Laser Safety. General Provisions" and ГОСТ Р 50723 – 94 "Laser Safety. General Safety Requirements upon Development and Operation of Laser Products". In addition, we suggest referring the new standards to the System of Labor Safety Standards (SLSS). Thus, we obtain the following common name of new standards system on LS – "SLSS. Lasers and Laser Facilities (Systems). Laser Safety". Hereinafter we will designate the project standards system on LS as SLSS LS.
Names of the project standards of SLSS LS system and information of compliance of the project standards with international and regional (European) standards as well as national standards of the USA are presented in the table. Also the table contains names of the relevant national standards of the Russian Federation and interstate standards which operation must be restricted on the territory of the Russian Federation, CIS and Custom Union (CU) limiting the standardization subjects only with the exported products.
Besides standards, the system of metrological support must be supplemented with the measurement rules. Therefore, in addition to the standards introduction of the following metrology rules is suggested:
PR 50.2.ХХХ.1 – 20ХХ. State System for Ensuring Uniform Measurement. Lasers and Laser Facilities (Systems). Laser Safety. Methods of Selection of Inspection Points When Performing the Laser Radiation Monitoring at Working Places (hereinafter, PR 50.2-1);
PR 50.2.ХХХ.2 – 20ХХ. State System for Ensuring Uniform Measurement. Lasers and Laser Facilities (Systems). Laser Safety. Laser Dosimeters. Inspection Methods (hereinafter, PR 50.2-2).
We will give short explanations.
1. In ГОСТ -1 the main principles of LS system are established and the scheme of formation of SLSS LS system is described. The system compliance with the norms of current federal legislation is established. The level of interaction of regulatory documents of SLSS LS system with regulatory documents of the Federal Service for Supervision of Consumer Rights Protection and Human Well-Being and Ministry of Health of the Russian Federation as well as other appropriate standards of ГОСТ and ГОСТ Р systems (in case of limitation of standardization subject with the exported products only, standards of ГОСТ Р IEC 60825 series are mentioned with the relevant explanations) is established. General requirements of LS assurance upon export-import operations are established.
Section "Classification of Laser Equipment by Hazard Level" is entered in the compulsory Appendix with the reference to the interstate sanitary-hygienic regulatory document of Custom Union USHR – 2010 (Uniform Sanitary and Hygienic Requirements) [21] and SN 5804 (Sanitary Norms) [22] as in force on the date of ГОСТ-1 development finishing. Maximum permissible level (MPL) values are mentioned in the form of references to the documents [21] and [22]. The table of compliance of classification schemes according to ГОСТ -1 and ГОСТ Р IEC-1 is given.
2. Application scope and standardization subject of ГОСТ-2 are determined in its name. The main provisions of ГОСТ Р 50723 are used in the text of standard with considerable amendments and additions. Safety requirements upon the development and operation of the following equipment are specified in the form of separate sections:
technological laser equipment;
data and measuring laser equipment;
medical laser equipment;
laser equipment intended for use in open spaces.
Level of interaction with ГОСТ Р IEC 60601-2-22 – 2008 [13] is established in the section which regulates the requirements for the medical laser equipment.
3. ГОСТ-3 is introduced in the form of standard which is modified in relation to IEC/TR 60825-13. ГОСТ-3 will not be the same as foreign analogue because it will use the national MPLs of laser radiation and national classification levels (CL) of LPs by hazard levels of laser radiation (LR). The standard will specify the requirements with regard to the methods and measurement tools (MTs) of LR parameters in accordance with the national system of metrological support in this measurement range.
Besides, it is assumed that appendices to the standard will set forth the specific types of national measurement tools of LP output parameters.
4. ГОСТ-4 is introduced in the form of amended ГОСТ Р 12.1.031 – 2010 "SLSS. Lasers. Methods of Laser Radiation Monitoring" [23]. Name of the standard will be insignificantly changed with regard to introduction of new name of the common standardization subject and the new reference designation will be entered. In addition, Appendix E "Methods of Selection of Points of Laser Radiation Monitoring" will be excluded from the standard and executed in the form of separate regulatory document PR 50.2-1.
5. ГОСТ-5 is introduced for the first time. Regulated calculation methods will be based on formulas specified in the document [24]. ГОСТ -5 will only use the formulas which refer to the assessment of LR hazard level using the norms (MPLs) for acute single exposure provided in the documents [21] and [22]. Methods of instrumental monitoring (radiation monitoring) of LR in open spaces using the laser dosimeters will be developed for the first time.
6. ГОСТ-6 is introduced for the first time and represents the analogue of considerably modified European regional standards – EN 207:2009/AC:2011 [16] and ЕN 208:2009 [17].
7. ГОСТ-7 is introduced for the first time and represents considerably modified international standard IEC 60825-4. ГОСТ -7 will not be identical to foreign analogue because it will use national MPLs of laser radiation and national CLs of LPs. Appendices to the standard will set forth the specific types of national MTs of LR parameters which are expected to be used for the testing of LR individual and collective protective equipment.
8. PR 50.2-1 is the improved variant of current recommendations in metrology – PR 50.2.025-2002 [25]. Changes introduction is expected in relation to the list of measurement tools used upon calibration.
9. PR 50.2-2 represents re-executed Appendix E to ГОСТ Р 12.1.031 [23].
In order to develop SLSS LS system it is suggested to form the workgroup (WG) based on four organizations: N.E. Bauman Moscow State Technical University (Department E9 "Ecology and Industrial Safety", Department Chairman – A.A. Alexandrov, Professor, Doctor of Engineering, Rector of the Moscow State Technical University); FSUE ARRIOPM of the Federal Agency on Technical Regulating and Metrology (Research Organization of Laser Metrology and Radiometry and Laboratory of Biophysical and Special Data-Measuring Systems); Institute of Laser Physics "Research and Manufacturing Corporation "S.I. Vavilov State Optical Institute" (Department of Nanophotonics); Autonomous Non-Commercial Organization "AtomTechnoTest".
It is assumed that medical and biological specialists of the following organizations will be involved in the development process of SLSS LS in the capacity of experts-consultants: Research Institute of Occupational Health of the Russian Academy of Medical Sciences (Laboratory of Physical Factors); North-West Scientific Center of Hygiene and Public Health of the Federal Service for Supervision of Consumer Rights Protection and Human Well-Being (Group of Laser Radiation Hygiene); A.I. Burnazyan Federal Medical-Biological Center of the Federal and Biological Agency of Russia (Laboratory of Radiobiology and Hygiene of Non-Ionizing Radiation); M.F. Vladimirsky Moscow Regional Research Clinical Institute of the Ministry of Health of Moscow Region (Laboratory of Medical and Physical Research); All-Russian Research and Test Institute of Medical Equipment of the Federal Service for Supervision of Public Health.
We make the request to our readers to give us their remarks, additions and suggestions on the structure of new SLSS LS system and list of organizations which employees can be a part of WG on the development of SLSS LS.
It should be emphasized that the development of SLSS LS has the following main objectives:
elimination of the situation of legal collision in LS regulatory system via the mutual harmonization of new national technical standards and new sanitary-hygienic regulatory documents in the area of LS;
ensuring of safe use of laser products at working places as well as in open spaces;
provision of the regulatory system of technical procedures of Custom Union [26] and [27] with modern efficient regulatory documents on LS harmonized with interstate sanitary-hygienic regulatory document of Custom Union [21];
provision of the regulatory system of new technical procedure of Custom Union on laser products safety (TP CU LS) development of which is stipulated by the "roadmap" of photonics development approved on the basis of order of the Government of the Russian Federation dated 24.07.2013 No. 1305-р.
It should be noted that the development of TP CU LS project is not very complicated and labor-consuming work in comparison with the volume of works on formation of SLSS LS system because TP CU LS will inherently be the set of the most general requirements on LS which will be set forth in the projects of new standards ГОСТ -1 – ГОСТ -7. It is our opinion that the scheme of laser products (LPs) certification which will be set forth in TP CU LS should be borrowed from the document [26].
It will be quite logical if the development of TP CU LS project will be performed by the WG formed for the development of SLSS LS. Also the workgroup should develop the lists of standards (SL CU LS) ensuring the confirmation of compliance with the requirements of TP CU LS for LPs intended for domestic CU market (including the standards of SLSS LS into SL CU LS) as well as LPs intended for export (including the revised standards of ГОСТ Р IEC 60825 system and revised ГОСТ Р 54836 and ГОСТ Р 54838 – ГОСТ Р 54842 into SL CU LS).
It should be concluded that currently the USA apply their own system of standards in LS area (see table) and as opposed to the Russian Federation they do not directly apply the standards of IEC 60825 series. Herewith, series of ANSI Z 136 include the standards which regulate the safety of LPs application in open spaces where some requirements which are absent in the standards of IEC 60825 series are established. When developing the system of standards SLSS LS and TP CU LS, individual useful provisions of Z136.5 and Z136.6 standards [20] will be taken into account to a certain extent.
Finishing the issue consideration on improvement of national and interstate regulatory system in the area of LS there is a further point to be made here. Technologies in the area of photonics are not limited to laser technologies only; therefore, the issue of safety assurance of not only laser equipment but whole non-coherent photonics (NCP) as well is topical. This publication volume does not make it possible to consider the modern condition in the area of NCP safety in details. However, it should be noted that the tendency of direct transition to the international regulatory documents is observed in this area without consideration of current national regulatory documents. For example, currently the project of standard "Photobiological Safety of Lamps and Lamp Systems" is published on the Internet. This standard is identical to IEC 62471:2006 [28]. Developers of this standard repeat mistakes of the authors of translated standards of IEC 60825 series in many aspects, first of all, neglecting the current terminological base in the area of rate setting of physical influencing factors (particularly, in the area of electromagnetic radiation in visible spectral region). In future we plan publishing the article with the suggestions on improvement of regulatory system in the area of "photodiode" and "lamp" safety as well as in the area of safety of products generating non-coherent optical radiation in UV and IR spectral regions. ▪
We suggest calling the main common standardization subject of standards project system on laser safety similarly – "Lasers and Laser Facilities (Systems)". We offer borrowing the name of the second common standardization subject – Laser Safety – from the following standards: ГОСТ 12.1.040 – 83 "System of Labor Safety Standards. Laser Safety. General Provisions" and ГОСТ Р 50723 – 94 "Laser Safety. General Safety Requirements upon Development and Operation of Laser Products". In addition, we suggest referring the new standards to the System of Labor Safety Standards (SLSS). Thus, we obtain the following common name of new standards system on LS – "SLSS. Lasers and Laser Facilities (Systems). Laser Safety". Hereinafter we will designate the project standards system on LS as SLSS LS.
Names of the project standards of SLSS LS system and information of compliance of the project standards with international and regional (European) standards as well as national standards of the USA are presented in the table. Also the table contains names of the relevant national standards of the Russian Federation and interstate standards which operation must be restricted on the territory of the Russian Federation, CIS and Custom Union (CU) limiting the standardization subjects only with the exported products.
Besides standards, the system of metrological support must be supplemented with the measurement rules. Therefore, in addition to the standards introduction of the following metrology rules is suggested:
PR 50.2.ХХХ.1 – 20ХХ. State System for Ensuring Uniform Measurement. Lasers and Laser Facilities (Systems). Laser Safety. Methods of Selection of Inspection Points When Performing the Laser Radiation Monitoring at Working Places (hereinafter, PR 50.2-1);
PR 50.2.ХХХ.2 – 20ХХ. State System for Ensuring Uniform Measurement. Lasers and Laser Facilities (Systems). Laser Safety. Laser Dosimeters. Inspection Methods (hereinafter, PR 50.2-2).
We will give short explanations.
1. In ГОСТ -1 the main principles of LS system are established and the scheme of formation of SLSS LS system is described. The system compliance with the norms of current federal legislation is established. The level of interaction of regulatory documents of SLSS LS system with regulatory documents of the Federal Service for Supervision of Consumer Rights Protection and Human Well-Being and Ministry of Health of the Russian Federation as well as other appropriate standards of ГОСТ and ГОСТ Р systems (in case of limitation of standardization subject with the exported products only, standards of ГОСТ Р IEC 60825 series are mentioned with the relevant explanations) is established. General requirements of LS assurance upon export-import operations are established.
Section "Classification of Laser Equipment by Hazard Level" is entered in the compulsory Appendix with the reference to the interstate sanitary-hygienic regulatory document of Custom Union USHR – 2010 (Uniform Sanitary and Hygienic Requirements) [21] and SN 5804 (Sanitary Norms) [22] as in force on the date of ГОСТ-1 development finishing. Maximum permissible level (MPL) values are mentioned in the form of references to the documents [21] and [22]. The table of compliance of classification schemes according to ГОСТ -1 and ГОСТ Р IEC-1 is given.
2. Application scope and standardization subject of ГОСТ-2 are determined in its name. The main provisions of ГОСТ Р 50723 are used in the text of standard with considerable amendments and additions. Safety requirements upon the development and operation of the following equipment are specified in the form of separate sections:
technological laser equipment;
data and measuring laser equipment;
medical laser equipment;
laser equipment intended for use in open spaces.
Level of interaction with ГОСТ Р IEC 60601-2-22 – 2008 [13] is established in the section which regulates the requirements for the medical laser equipment.
3. ГОСТ-3 is introduced in the form of standard which is modified in relation to IEC/TR 60825-13. ГОСТ-3 will not be the same as foreign analogue because it will use the national MPLs of laser radiation and national classification levels (CL) of LPs by hazard levels of laser radiation (LR). The standard will specify the requirements with regard to the methods and measurement tools (MTs) of LR parameters in accordance with the national system of metrological support in this measurement range.
Besides, it is assumed that appendices to the standard will set forth the specific types of national measurement tools of LP output parameters.
4. ГОСТ-4 is introduced in the form of amended ГОСТ Р 12.1.031 – 2010 "SLSS. Lasers. Methods of Laser Radiation Monitoring" [23]. Name of the standard will be insignificantly changed with regard to introduction of new name of the common standardization subject and the new reference designation will be entered. In addition, Appendix E "Methods of Selection of Points of Laser Radiation Monitoring" will be excluded from the standard and executed in the form of separate regulatory document PR 50.2-1.
5. ГОСТ-5 is introduced for the first time. Regulated calculation methods will be based on formulas specified in the document [24]. ГОСТ -5 will only use the formulas which refer to the assessment of LR hazard level using the norms (MPLs) for acute single exposure provided in the documents [21] and [22]. Methods of instrumental monitoring (radiation monitoring) of LR in open spaces using the laser dosimeters will be developed for the first time.
6. ГОСТ-6 is introduced for the first time and represents the analogue of considerably modified European regional standards – EN 207:2009/AC:2011 [16] and ЕN 208:2009 [17].
7. ГОСТ-7 is introduced for the first time and represents considerably modified international standard IEC 60825-4. ГОСТ -7 will not be identical to foreign analogue because it will use national MPLs of laser radiation and national CLs of LPs. Appendices to the standard will set forth the specific types of national MTs of LR parameters which are expected to be used for the testing of LR individual and collective protective equipment.
8. PR 50.2-1 is the improved variant of current recommendations in metrology – PR 50.2.025-2002 [25]. Changes introduction is expected in relation to the list of measurement tools used upon calibration.
9. PR 50.2-2 represents re-executed Appendix E to ГОСТ Р 12.1.031 [23].
In order to develop SLSS LS system it is suggested to form the workgroup (WG) based on four organizations: N.E. Bauman Moscow State Technical University (Department E9 "Ecology and Industrial Safety", Department Chairman – A.A. Alexandrov, Professor, Doctor of Engineering, Rector of the Moscow State Technical University); FSUE ARRIOPM of the Federal Agency on Technical Regulating and Metrology (Research Organization of Laser Metrology and Radiometry and Laboratory of Biophysical and Special Data-Measuring Systems); Institute of Laser Physics "Research and Manufacturing Corporation "S.I. Vavilov State Optical Institute" (Department of Nanophotonics); Autonomous Non-Commercial Organization "AtomTechnoTest".
It is assumed that medical and biological specialists of the following organizations will be involved in the development process of SLSS LS in the capacity of experts-consultants: Research Institute of Occupational Health of the Russian Academy of Medical Sciences (Laboratory of Physical Factors); North-West Scientific Center of Hygiene and Public Health of the Federal Service for Supervision of Consumer Rights Protection and Human Well-Being (Group of Laser Radiation Hygiene); A.I. Burnazyan Federal Medical-Biological Center of the Federal and Biological Agency of Russia (Laboratory of Radiobiology and Hygiene of Non-Ionizing Radiation); M.F. Vladimirsky Moscow Regional Research Clinical Institute of the Ministry of Health of Moscow Region (Laboratory of Medical and Physical Research); All-Russian Research and Test Institute of Medical Equipment of the Federal Service for Supervision of Public Health.
We make the request to our readers to give us their remarks, additions and suggestions on the structure of new SLSS LS system and list of organizations which employees can be a part of WG on the development of SLSS LS.
It should be emphasized that the development of SLSS LS has the following main objectives:
elimination of the situation of legal collision in LS regulatory system via the mutual harmonization of new national technical standards and new sanitary-hygienic regulatory documents in the area of LS;
ensuring of safe use of laser products at working places as well as in open spaces;
provision of the regulatory system of technical procedures of Custom Union [26] and [27] with modern efficient regulatory documents on LS harmonized with interstate sanitary-hygienic regulatory document of Custom Union [21];
provision of the regulatory system of new technical procedure of Custom Union on laser products safety (TP CU LS) development of which is stipulated by the "roadmap" of photonics development approved on the basis of order of the Government of the Russian Federation dated 24.07.2013 No. 1305-р.
It should be noted that the development of TP CU LS project is not very complicated and labor-consuming work in comparison with the volume of works on formation of SLSS LS system because TP CU LS will inherently be the set of the most general requirements on LS which will be set forth in the projects of new standards ГОСТ -1 – ГОСТ -7. It is our opinion that the scheme of laser products (LPs) certification which will be set forth in TP CU LS should be borrowed from the document [26].
It will be quite logical if the development of TP CU LS project will be performed by the WG formed for the development of SLSS LS. Also the workgroup should develop the lists of standards (SL CU LS) ensuring the confirmation of compliance with the requirements of TP CU LS for LPs intended for domestic CU market (including the standards of SLSS LS into SL CU LS) as well as LPs intended for export (including the revised standards of ГОСТ Р IEC 60825 system and revised ГОСТ Р 54836 and ГОСТ Р 54838 – ГОСТ Р 54842 into SL CU LS).
It should be concluded that currently the USA apply their own system of standards in LS area (see table) and as opposed to the Russian Federation they do not directly apply the standards of IEC 60825 series. Herewith, series of ANSI Z 136 include the standards which regulate the safety of LPs application in open spaces where some requirements which are absent in the standards of IEC 60825 series are established. When developing the system of standards SLSS LS and TP CU LS, individual useful provisions of Z136.5 and Z136.6 standards [20] will be taken into account to a certain extent.
Finishing the issue consideration on improvement of national and interstate regulatory system in the area of LS there is a further point to be made here. Technologies in the area of photonics are not limited to laser technologies only; therefore, the issue of safety assurance of not only laser equipment but whole non-coherent photonics (NCP) as well is topical. This publication volume does not make it possible to consider the modern condition in the area of NCP safety in details. However, it should be noted that the tendency of direct transition to the international regulatory documents is observed in this area without consideration of current national regulatory documents. For example, currently the project of standard "Photobiological Safety of Lamps and Lamp Systems" is published on the Internet. This standard is identical to IEC 62471:2006 [28]. Developers of this standard repeat mistakes of the authors of translated standards of IEC 60825 series in many aspects, first of all, neglecting the current terminological base in the area of rate setting of physical influencing factors (particularly, in the area of electromagnetic radiation in visible spectral region). In future we plan publishing the article with the suggestions on improvement of regulatory system in the area of "photodiode" and "lamp" safety as well as in the area of safety of products generating non-coherent optical radiation in UV and IR spectral regions. ▪
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