rus
Issue #6/2013
B.Rakhmanov, V.Devisilov, A.Mitrofanov, V.Kibovsky
Issues of safe laser equipment application technical regulation. Part I. Customs Union’s Technical Regulations
Issues of safe laser equipment application technical regulation. Part I. Customs Union’s Technical Regulations
The Russian regulatory base for laser equipment operation is formed by two systems of regulatory documents which often disagree in many aspects. This situation already affects the entire CIS and the Customs Union. One possible solution of the problem is application of the Technical Regulations of the Customs Union.
During the last four years the situation of legal collision has appeared in the national system of statutory and legal regulation of laser equipment safe application. How is it expressed? Within the territory of the Russian Federation the national system of regulatory documents (RD) traditionally operates in the area of laser safety (LS). Also there is system of LS norms in the documents of International Electrotechnical Commission (IEC), these are the standards of IEC 60825 series. As soon as these international standards were given effect on the territory of the Russian Federation without any restrictions [1-3] the contradictions between them and national LS norms were found.
There is the concept of maximum permissible level (MPL) of laser radiation (LR). If laser radiation generated by the laser device exceeds the norm then it becomes clear that its use is hazardous, and strict measures should be taken in order to ensure the safety of people who can get into the radiation field of such device. The main national regulatory document which contains the norms of laser radiation MPLs is the Sanitary Norms and Rules of Lasers Structure and Operation СН 5804 – 91 [4] (hereinafter, "SN"). Let us now refer to the document IEC 60825-1:2007 "Safety of laser products – Part 1: Equipment classification and requirements" [5] (hereinafter, "IEC 60825-1"). It also regulates the MPL values, however for the spectral range 380 – 600 nm such norms are established that they considerably exceed the values applied in the national LS system. In other words, the application of IEC standards results in the considerable understating of the hazard level of laser products (LPs) and misleads the users of laser products [1-3].
Besides the sanitary norms [4], the following technical regulatory documents (national standards) are traditionally in effect in the area of LS within the territory of the Russian Federation:
GOST 12.1.040 – 83 Standards System of Labor Safety. Laser Safety. General Provisions [6];
GOST R 50723 – 94 Laser Safety. General Safety Requirements upon Development and Operation of Laser Products [7];
GOST R 12.1.031 – 2010 Standards System of Labor Safety. Lasers. Methods of Laser Radiation Monitoring [8].
Also different industry and departmental RDs which regulate the matters of safety when applying the lasers in different fields of activities refer to the regulatory system of LS. There are about twenty RDs in such area and all of them rely on the requirements of SN in a varying degree [4]. The specified standards are interconnected with SNs [4]. It should be noted that if we assume the year of standard approval, 1983, as the reference point it can be considered that the national system of LS will be 30 years old this year.
Also it should be noted that MPLs which are regulated in the basic standard IEC 60825-1 are the guidelines of the USA which had been established 40 years ago (in 1973) in the national standard of the USA ANSI Z 136.1 – 1973 American National Standard for Safe Use of Lasers. MPLs which are regulated in SN [4] were developed in the USSR 18 years later by the representative workgroup of national experts in the area of medicine and biology and experts in the area of laser technology and metrology. National standards are well-grounded and progressive and based on the results obtained by the medical and biological science in the late 80s in the area of study of mechanisms of the laser radiation biological effect on human body [3, 9].
Legal collision occurred after the enactment of eleven translated national standards within the territory of the Russian Federation which are identical to the standards of IEC 60825 series. Since 2009 four standards of GOST R IEC 60825 [10-13] series have been in effect. The standard GOST R IEC 60825-4 [14] has been given effect since 01.09.2013 as well as the group of standards: GOST R 54836 [15], GOST R 54838 – GOST R 54842 [16–20] which are identical to IEC standards.
The legal collision went beyond the territory of the Russian Federation in June 2013 and spread to the territory of CIS and Custom Union (CU) after adopting the interstate standard GOST IEC 60825-1 – 2013 by several CIS countries which is analogous to the national standard GOST R IEC 60825-1 – 2009 [10] (hereinafter, "GOST R IEC-1").
The following well-reasoned suggestions on the solution of the legal collision which occurred in the LS regulatory system (RS) are given in the papers [1-3]:
Limit the subjects of standardization of the aforementioned translated standards which are identical to the standards of IEC 60825 series with exported laser products only;
Carry out the repeated linguistic examination of above listed translated standards and according to its results review the individual standards and considerably amend the standards which permit the amendments procedure application;
Develop the national standards of LS to replace the outdated national standards on the territory of the Russian Federation and all above listed translated standards based on IEC norms. New standards should be harmonized with the new interstate sanitary and hygiene regulatory documents of CU and analogous documents of the Russian Federation which regulate the requirements of laser safety and should be partially harmonized with IEC and ISO standards which relate to LS issues.
In this article we consider the issues of practical implementation of the third suggestion from the list given above. During the recent years in our country the main technical statutory and regulatory document which regulates the safety of different products at all stages of their existence starting from design and finishing by recycling has been the technical rules (TR). Technical rules are developed in accordance with the Federal Law on Technical Regulation dated 27.12.2002 No. 184- ФЗ (hereinafter, "FL No. 184"). The national standards are developed in accordance with it. In Clause 2 of FL No. 184 the "technical rules" are defined as "the document which is adopted by the international agreement of the Russian Federation, … or federal law or edict of the President of the Russian Federation, or decree of the Government of the Russian federation and establishes the requirements which are mandatory for the application and execution to the subjects of technical regulation (products, … processes of manufacturing, operation, storage, transportation, sale and recycling)".
Clause 6 of FL No. 184 interprets the main purpose of TR adoption as follows: "the technical rules are adopted with the purposes of protection of life and health of citizens, property of individuals and legal entities, … environmental protection, … prevention of actions which mislead users".
In recent years FL No. 184 has been considerably amended particularly in issues which relate to the legal collision occurred in the regulatory system (RS) of laser safety [3]. Paragraphs 3 and 4 have been included to the Clause 1 of FL No. 184 which content the following information in short form:
"3. Effect of this Federal Law does not apply to … sanitary and hygienic … measures in the area of labor safety, …" (Federal Law (FL) dated 01.05.2007 No. 65-ФЗ as amended).
"4. This Federal Law does not regulate relations connected with the development, adoption and execution of sanitary and hygiene requirements, … requirements in the area of labor safety …except for cases …of application and execution of such requirements for products and processes of design, …manufacturing, …operation connected with the requirements to products…" (FL dated 21.07.2011 No. 255-ФЗ as amended).
Limiting paragraphs 3 and 4 should be interpreted in the following manner.
First of all, sanitary and hygienic norms of the influencing factors, for instance, radiation MPLs should not be established in the technical RDs which come within the purview of FL No. 184 (in other words, in the technical rules and standards). However, of course, MPL values can be used and given in these documents covering certain technical products. MPL values are taken from the relevant sanitary and hygienic RDs which establish the "sanitary and epidemiological requirements" relative to the considered influencing physical factors, and provided that the reference on the used RD should be given. All of it relates to the issue of regulation of the technical products classes by their hazard level for human because the classification levels (CL) are based on the MPL values and each hazard class is determined by different degrees of the physical factor biological effect (for instance, radiation) on human. In other words, medical workers and biologists are responsible for the regulation of MPL and CL but not technical experts.
Secondly, the requirements connected with the provision of safe working conditions when manufacturing and applying the hazardous types of products through the correct workplace arrangement (in other words, matters of labor safety) should not be directly established in TRs and standards too.
It should be admitted that GOST R IEC-1 [10] does not meet the requirements of the specified paragraphs of FL No. 184 because it directly regulates the new norms of LS and new CLs of laser products by the laser radiation (LR) hazard level. Besides, as it was shown in the published work [3] GOST R IEC-1 contradicts the requirements of interstate sanitary and hygienic regulatory document called "Uniform Sanitary-Epidemiological and Hygienic Requirements to the Goods Which Are Subject to Sanitary-Epidemiological Supervision (Control) at Customs Border and on Customs Territory of Custom Union" [21] (hereinafter, USHR-2010) and requirements of current SNs [4]. Therefore, it should be admitted that GOST R IEC-1 does not meet the requirements of another Federal Law on Sanitary-Epidemiological Welfare of the Population dated 30.03.1999 No. 52-ФЗ.
Currently the safety technical regulation of many types of products is performed at the interstate level within the framework of Custom Union (CU). It is reflected in the development of relevant technical rules of Custom Union (TR CU).
Decree of the Government of the Russian Federation No. 1305-р (hereinafter, "GD No. 1305-р") dated 24.07.2013 establishes a number of measures in order to ensure the priority development of photonics technologies in Russia. The following statement is given in Paragraph 1 of the document: "approve the attached action plan ("road-map") called "Development of Optical-Electronic Technologies of Photonics" (hereinafter this action plan will be designated as "road-map"). In Section IV of the road-map "Improvement of the State Regulation" there is paragraph 18 in accordance with which "the development of technical rules of Custom Union on laser products safety harmonized with the standards of European Union" is provided (performance period – 2016). Hereinafter we will designate this projected RD as TR CU LS.
The road-map provides rather long period for the development of TR CU LS and the issues of regulatory provision of LP certification under the conditions of existing legal collision in regulatory system of LS [3] require immediate solution. Let us consider the effective TRs CU which relate to LP and LS. It should be noted that currently such subject of the technical regulation as "quantum electronic products" (code of products 63 4200 according to All-Russian Classification of Products) is not provided in the valid Uniform List of Products Which Are Subject to the Mandatory Assessment (Confirmation) of Compliance within the Framework of Custom Union. However, enrolment of laser products in the mentioned Uniform List should be expected in the near future because the development task of TR CU LS was approved in GD No. 1305-p (see information above).
Currently, the following TRs CU are in effect where the measures of products control are provided for the compliance with LS requirements:
TR CU 004/2011 on Safety of Low-Voltage Equipment [22] (has come into effect since 01.07.2012);
TR CU 010/2011 on Safety of Machines and Equipment [23] (has come into effect since 15.02.2013).
The products which underwent the confirmation procedure of compliance with the requirements of these two documents and the relevant documentary evidence (certificates, declarations of compliance) are labeled with EAC mark (Euro-Asian Compliance).
Let us consider the document [22]. Clause 1 gives the following statement: "electric equipment designated for use at rated voltage of 50 to 1000 V (inclusive) alternating current and 75 to 1500 V (inclusive) direct current refers to the low-voltage equipment which these technical rules of Custom Union apply to".
The following term is defined in Clause 2 [22] "Definitions": "electric equipment is the equipment designated for generation, conversion, transmission and use of electric energy including the equipment which is directly used as well as the equipment built in machines, mechanisms, apparatus and other devices".
Since any LP operates on the basis of "use of electric energy" in accordance with the given definition it formally comes within the purview of the document [22] if it has the specified supply voltage levels. Within the context of the document [22] any LPs do not differ from TV sets or monitors which are subject to mandatory certification in accordance with the list of products which are subject to the mandatory control for compliance with the requirements [22], as it will be shown hereinafter. Ultimately, all these products convert the electric energy into the optical radiation energy.
In Clause 4 [22] "Safety Requirements" the following requirements are established: "low-voltage equipment must be designed and manufactured in order to provide the following when using it according to its intended purpose and meeting the requirements for its installation, operation:
required level of protection against the direct and indirect electric current exposure;
absence of impermissible risk of high temperatures, arc discharges or radiation which can cause the hazards occurrence;
required level of protection against the hazards of non-electric origin, … including the hazards caused by physical … factors".
"List of Low-Voltage Equipment Which Is Subject to Confirmation in the Form of Certification in Accordance with the Technical Rules of Custom Union on Safety of Low-Voltage Equipment" exists as Appendix to the document [22] (hereinafter, "List of LVE"). The List of LVE contains 9 items by the groups of products which are subject to the mandatory certification. LPs can refer to the following groups:
"1. Electric apparatus and devices for household use" (subgroups: "gaming, sport and training equipment" and "audio and video equipment, receivers of TV and radio broadcasting").
"2. Personal computers" (hereinafter PC).
"3. Low-voltage equipment connected to the personal computers" (for instance, laser printers).
Concerning "audio and video equipment", practically all such equipment operates using the laser semiconductor diodes (LSD). LSDs are included into the structure of many PCs. Currently LSDs are applied in the "sport and training equipment" as well.
In addition to the document [22] there is "List of Standards Application of Which Results in Compliance with the Requirements of Technical Rules of Custom Union on Safety of Low-Voltage Equipment" (hereinafter, "List of Standards of LVE").
The standards GOST R IEC-1 [10] and STB IEC 60825-1 -2011 [24] are given in the List of Standards of LVE under No. 294. In the published papers [1-3] it is established that application of GOST R IEC-1 within the territory of the Russian Federation is illegitimate due to its contradiction relative to the requirements of USHR-2010 [21] and SNs [4]. Moreover, the application of GOST R IEC-1 within the territory of the Russian Federation is essentially illegitimate due to its non-compliance with the requirements of FL No. 184 and FL No. 52. Standard of the Republic of Belarus STB IEC 60825-1 – 2011 cannot be applied within the territory of the Russian Federation for the same reasons as GOST R IEC-1. The following question arises: how is it possible to confirm the safety of LPs and different types of LVE which use LPs and compliance with the requirements [22] when carrying out the mandatory or voluntary certification?
The following paragraph is in Clause 7 Paragraph 2 [22] "Confirmation of Compliance":
"In case of failure to apply the standards specified in Clause 6 Paragraph 1 (in other words, specified in the List of Standards of LVE) of these technical rules of Custom Union or in case of their absence the confirmation of compliance of low-voltage equipment is performed in the form of certification (schemes 1c, 3c, 4c) in accordance with Paragraph 10 of this clause".
Thus, currently well-grounded refusal to apply GOST R IEC-1 does not allow confirming the compliance of LPs with the requirements [22] in the form of compliance declaration for the developer but it allows undergoing more complicated procedure of LP certification with the involvement of authorized certification bodies.
Clause 7 Paragraph 10 states that in case described in Clause 7 Paragraph 2, "manufacturer …, importer provides to the certification authority … the package of low-voltage equipment documents" confirming the compliance of LVE with the requirements of this document [22] which includes specifications, operating procedures, description of adopted technical solutions and "assessment of risks which confirms the fulfillment of requirements" of this document [22].
Thus, currently when refusing to apply GOST R IEC-1 it is sufficient to provide the confirmation of the product compliance with the requirements of USHR-2010 [21], in other words, to submit the simple calculation to the certification authority confirming that upon the assessment of compliance with the LS requirements tighter standards of MPL were used (including the situations when determining CLs) than upon use of GOST R IEC-1. This calculation is essentially the actual assessment of hazard level or assessment of actual risk of laser radiation generated by certifiable LP or any other certifiable LVE which contains LP.
Let us briefly consider the document [23]. There are following terms in Clause 2 "Definitions" of the document:
"Machine is the number of interconnected parts and units where at least one part or unit moves with the help of the relevant drives, control circuits, energy sources integrated for the specific use …";
"Equipment is the technical device applicable separately or installable on machine which is necessary for the performance of main and/or additional functions …".
Such expanded interpretation of the term "equipment" makes it possible to use it for any laser product (which undoubtedly is the "technical device") designated for carrying out any individual technical operations and for the LP which is built in the "machine" and favors to the performance of the main and additional functions of the "machine". Rather wide range of existing LPs can be referred to such "laser equipment" (LE). Let us note that upon the use of the requirements [23] as opposed to the requirements [22] in relation to LPs the supply voltage required for the LP operation is not important.
There are two lists of technical regulation subjects (TRS) for which the confirmation of compliance with the requirements [23] is compulsory: the list of TRSs which are subject to the confirmation of compliance in the form of certification (hereinafter, "List of TRSs 1) and list of TRSs which are subject to the confirmation of compliance in the form of compliance declaration (hereinafter, "List of TRSs 2).
There are 15 items in the List of TRSs 1 by the groups of products. According to our estimates the use of LPs in the specified groups is unlikely. There are 60 items in the List of TRSs 2 by the groups of products. We paid attention to several items where LPs can be used:
"23. Woodworking equipment (except for woodworking machines)";
"25. Equipment for welding and thermal spraying";
"41. Processing equipment for light industry";
"42. Processing equipment for textile industry".
Some laser machining systems (LMS) refer to these types of products. For example, LMSs for laser welding (p. 25); LMSs for the formation of openings and sections with complex shapes in different wood materials using laser beam (LB) (p. 23); LMSs for cutting of different materials and textile using LB (p. 41, p. 42).
There is Appendix No. 1 to the document [23] "Main Requirements for the Safety of Machines and/or Equipment" and it has the following paragraph:
"57. When using the laser equipment the following actions must be performed:
Accidental radiation must be prevented;
Protection against direct, reflected, scattered and secondary radiation must be provided;
Absence of hazard from optical equipment must be provided for the observation or adjustment of laser equipment".
Presence of Paragraph 57 confirms that developers [23] assumed beforehand that any laser equipment (LE) used separately as well as in different machines (in other words, in devices with actuated parts) came within the requirements of these technical rules. Of course, those types of LE which did not come within the List of TRSs 2 can undergo the voluntary procedures of certification or declaration of compliance with the requirements [23].
In addition to the document [23] there is "List of Standards Application of Which on Voluntary Basis Results in Compliance with the Requirements of Technical Rules of Custom Union on Safety of Machines and Equipment" (hereinafter, "List of Standards of ME").
The section "Standards of Group B (Group Issues of Safety)" in the List of Standards of ME gives the only standard which relates to LS. This is the main standard of existing traditional national system of LS – GOST 12.1.040 – 83 "Standards System of Labor Safety. Laser Safety. General Provisions" [6].
In our opinion, developers of the document [23] and List of Standards of ME as opposed to developers of the document [22] and List of Standards of LVE stood for the correct opinion giving preference to the national standard on LS [6]. As a result of such solution currently there are no problems when confirming the compliance of LP (LE) with the requirements [23] with any form of confirmation.
This may be due to the fact that there is p. 3.1 in GOST 12.1.040 [6] where the following statement is directly given: "maximum permissible levels of laser radiation, … are determined in accordance with the requirements of Sanitary Norms and Rules of Lasers Structure and Operation". Besides, p. 2.3 of this standard regulates 4 classes of LPs by the hazard level of LPs which are identical to the classes regulated in USHR-2010 and SN 5804-91.
Finishing the consideration of new technical rules of Custom Union ([22] and [23]) we can assert that currently practically all LPs can undergo the certification in order to confirm the compliance with the requirements [22] or requirements [23]. In other words, currently there is operating mechanism of safety confirmation of practically every LP and receipt of the relevant documentary evidence.
Thus, for the period to the end of 2016, in other words, up to the enforcement date of individual technical rules on LS provided by the "road-map" the documents [22] or [23] should be used for the confirmation of quality and safety of laser products. Herewith, currently the issue on creation of new system of LS standards should be solved in the first place which will replace the system of standards GOST R IEC 60825 and standards GOST R 54836, GOST R 54838 – GOST R 54842 within the territory of the Russian Federation and CU. Also the new system of standards must replace the outdated national technical regulatory system on LS. Of course, new standards should rely on the current norms of LS and CL regulated in USHR-2010 [21] or SN 5804 as amended. Herewith, the new standards should use different reliable and beneficial provisions of the standards IEC and ISO to the maximum extent possible (except for the MPL values and classification levels of LPs).
The main purpose for the development of new standards is to provide the regulatory system [22] and [23] with up-to-date and effective regulatory documents on LS. Herewith, the task of provision of regulatory system of Custom Union LS technical rules scheduled by the road-map of photonics development will be simultaneously solved. Development of these technical rules of Custom Union can be performed simultaneously with the development of new standards but it should not advance it.
In the following part of the review we will present a number of suggestions for the new system of national standards on laser safety.
There is the concept of maximum permissible level (MPL) of laser radiation (LR). If laser radiation generated by the laser device exceeds the norm then it becomes clear that its use is hazardous, and strict measures should be taken in order to ensure the safety of people who can get into the radiation field of such device. The main national regulatory document which contains the norms of laser radiation MPLs is the Sanitary Norms and Rules of Lasers Structure and Operation СН 5804 – 91 [4] (hereinafter, "SN"). Let us now refer to the document IEC 60825-1:2007 "Safety of laser products – Part 1: Equipment classification and requirements" [5] (hereinafter, "IEC 60825-1"). It also regulates the MPL values, however for the spectral range 380 – 600 nm such norms are established that they considerably exceed the values applied in the national LS system. In other words, the application of IEC standards results in the considerable understating of the hazard level of laser products (LPs) and misleads the users of laser products [1-3].
Besides the sanitary norms [4], the following technical regulatory documents (national standards) are traditionally in effect in the area of LS within the territory of the Russian Federation:
GOST 12.1.040 – 83 Standards System of Labor Safety. Laser Safety. General Provisions [6];
GOST R 50723 – 94 Laser Safety. General Safety Requirements upon Development and Operation of Laser Products [7];
GOST R 12.1.031 – 2010 Standards System of Labor Safety. Lasers. Methods of Laser Radiation Monitoring [8].
Also different industry and departmental RDs which regulate the matters of safety when applying the lasers in different fields of activities refer to the regulatory system of LS. There are about twenty RDs in such area and all of them rely on the requirements of SN in a varying degree [4]. The specified standards are interconnected with SNs [4]. It should be noted that if we assume the year of standard approval, 1983, as the reference point it can be considered that the national system of LS will be 30 years old this year.
Also it should be noted that MPLs which are regulated in the basic standard IEC 60825-1 are the guidelines of the USA which had been established 40 years ago (in 1973) in the national standard of the USA ANSI Z 136.1 – 1973 American National Standard for Safe Use of Lasers. MPLs which are regulated in SN [4] were developed in the USSR 18 years later by the representative workgroup of national experts in the area of medicine and biology and experts in the area of laser technology and metrology. National standards are well-grounded and progressive and based on the results obtained by the medical and biological science in the late 80s in the area of study of mechanisms of the laser radiation biological effect on human body [3, 9].
Legal collision occurred after the enactment of eleven translated national standards within the territory of the Russian Federation which are identical to the standards of IEC 60825 series. Since 2009 four standards of GOST R IEC 60825 [10-13] series have been in effect. The standard GOST R IEC 60825-4 [14] has been given effect since 01.09.2013 as well as the group of standards: GOST R 54836 [15], GOST R 54838 – GOST R 54842 [16–20] which are identical to IEC standards.
The legal collision went beyond the territory of the Russian Federation in June 2013 and spread to the territory of CIS and Custom Union (CU) after adopting the interstate standard GOST IEC 60825-1 – 2013 by several CIS countries which is analogous to the national standard GOST R IEC 60825-1 – 2009 [10] (hereinafter, "GOST R IEC-1").
The following well-reasoned suggestions on the solution of the legal collision which occurred in the LS regulatory system (RS) are given in the papers [1-3]:
Limit the subjects of standardization of the aforementioned translated standards which are identical to the standards of IEC 60825 series with exported laser products only;
Carry out the repeated linguistic examination of above listed translated standards and according to its results review the individual standards and considerably amend the standards which permit the amendments procedure application;
Develop the national standards of LS to replace the outdated national standards on the territory of the Russian Federation and all above listed translated standards based on IEC norms. New standards should be harmonized with the new interstate sanitary and hygiene regulatory documents of CU and analogous documents of the Russian Federation which regulate the requirements of laser safety and should be partially harmonized with IEC and ISO standards which relate to LS issues.
In this article we consider the issues of practical implementation of the third suggestion from the list given above. During the recent years in our country the main technical statutory and regulatory document which regulates the safety of different products at all stages of their existence starting from design and finishing by recycling has been the technical rules (TR). Technical rules are developed in accordance with the Federal Law on Technical Regulation dated 27.12.2002 No. 184- ФЗ (hereinafter, "FL No. 184"). The national standards are developed in accordance with it. In Clause 2 of FL No. 184 the "technical rules" are defined as "the document which is adopted by the international agreement of the Russian Federation, … or federal law or edict of the President of the Russian Federation, or decree of the Government of the Russian federation and establishes the requirements which are mandatory for the application and execution to the subjects of technical regulation (products, … processes of manufacturing, operation, storage, transportation, sale and recycling)".
Clause 6 of FL No. 184 interprets the main purpose of TR adoption as follows: "the technical rules are adopted with the purposes of protection of life and health of citizens, property of individuals and legal entities, … environmental protection, … prevention of actions which mislead users".
In recent years FL No. 184 has been considerably amended particularly in issues which relate to the legal collision occurred in the regulatory system (RS) of laser safety [3]. Paragraphs 3 and 4 have been included to the Clause 1 of FL No. 184 which content the following information in short form:
"3. Effect of this Federal Law does not apply to … sanitary and hygienic … measures in the area of labor safety, …" (Federal Law (FL) dated 01.05.2007 No. 65-ФЗ as amended).
"4. This Federal Law does not regulate relations connected with the development, adoption and execution of sanitary and hygiene requirements, … requirements in the area of labor safety …except for cases …of application and execution of such requirements for products and processes of design, …manufacturing, …operation connected with the requirements to products…" (FL dated 21.07.2011 No. 255-ФЗ as amended).
Limiting paragraphs 3 and 4 should be interpreted in the following manner.
First of all, sanitary and hygienic norms of the influencing factors, for instance, radiation MPLs should not be established in the technical RDs which come within the purview of FL No. 184 (in other words, in the technical rules and standards). However, of course, MPL values can be used and given in these documents covering certain technical products. MPL values are taken from the relevant sanitary and hygienic RDs which establish the "sanitary and epidemiological requirements" relative to the considered influencing physical factors, and provided that the reference on the used RD should be given. All of it relates to the issue of regulation of the technical products classes by their hazard level for human because the classification levels (CL) are based on the MPL values and each hazard class is determined by different degrees of the physical factor biological effect (for instance, radiation) on human. In other words, medical workers and biologists are responsible for the regulation of MPL and CL but not technical experts.
Secondly, the requirements connected with the provision of safe working conditions when manufacturing and applying the hazardous types of products through the correct workplace arrangement (in other words, matters of labor safety) should not be directly established in TRs and standards too.
It should be admitted that GOST R IEC-1 [10] does not meet the requirements of the specified paragraphs of FL No. 184 because it directly regulates the new norms of LS and new CLs of laser products by the laser radiation (LR) hazard level. Besides, as it was shown in the published work [3] GOST R IEC-1 contradicts the requirements of interstate sanitary and hygienic regulatory document called "Uniform Sanitary-Epidemiological and Hygienic Requirements to the Goods Which Are Subject to Sanitary-Epidemiological Supervision (Control) at Customs Border and on Customs Territory of Custom Union" [21] (hereinafter, USHR-2010) and requirements of current SNs [4]. Therefore, it should be admitted that GOST R IEC-1 does not meet the requirements of another Federal Law on Sanitary-Epidemiological Welfare of the Population dated 30.03.1999 No. 52-ФЗ.
Currently the safety technical regulation of many types of products is performed at the interstate level within the framework of Custom Union (CU). It is reflected in the development of relevant technical rules of Custom Union (TR CU).
Decree of the Government of the Russian Federation No. 1305-р (hereinafter, "GD No. 1305-р") dated 24.07.2013 establishes a number of measures in order to ensure the priority development of photonics technologies in Russia. The following statement is given in Paragraph 1 of the document: "approve the attached action plan ("road-map") called "Development of Optical-Electronic Technologies of Photonics" (hereinafter this action plan will be designated as "road-map"). In Section IV of the road-map "Improvement of the State Regulation" there is paragraph 18 in accordance with which "the development of technical rules of Custom Union on laser products safety harmonized with the standards of European Union" is provided (performance period – 2016). Hereinafter we will designate this projected RD as TR CU LS.
The road-map provides rather long period for the development of TR CU LS and the issues of regulatory provision of LP certification under the conditions of existing legal collision in regulatory system of LS [3] require immediate solution. Let us consider the effective TRs CU which relate to LP and LS. It should be noted that currently such subject of the technical regulation as "quantum electronic products" (code of products 63 4200 according to All-Russian Classification of Products) is not provided in the valid Uniform List of Products Which Are Subject to the Mandatory Assessment (Confirmation) of Compliance within the Framework of Custom Union. However, enrolment of laser products in the mentioned Uniform List should be expected in the near future because the development task of TR CU LS was approved in GD No. 1305-p (see information above).
Currently, the following TRs CU are in effect where the measures of products control are provided for the compliance with LS requirements:
TR CU 004/2011 on Safety of Low-Voltage Equipment [22] (has come into effect since 01.07.2012);
TR CU 010/2011 on Safety of Machines and Equipment [23] (has come into effect since 15.02.2013).
The products which underwent the confirmation procedure of compliance with the requirements of these two documents and the relevant documentary evidence (certificates, declarations of compliance) are labeled with EAC mark (Euro-Asian Compliance).
Let us consider the document [22]. Clause 1 gives the following statement: "electric equipment designated for use at rated voltage of 50 to 1000 V (inclusive) alternating current and 75 to 1500 V (inclusive) direct current refers to the low-voltage equipment which these technical rules of Custom Union apply to".
The following term is defined in Clause 2 [22] "Definitions": "electric equipment is the equipment designated for generation, conversion, transmission and use of electric energy including the equipment which is directly used as well as the equipment built in machines, mechanisms, apparatus and other devices".
Since any LP operates on the basis of "use of electric energy" in accordance with the given definition it formally comes within the purview of the document [22] if it has the specified supply voltage levels. Within the context of the document [22] any LPs do not differ from TV sets or monitors which are subject to mandatory certification in accordance with the list of products which are subject to the mandatory control for compliance with the requirements [22], as it will be shown hereinafter. Ultimately, all these products convert the electric energy into the optical radiation energy.
In Clause 4 [22] "Safety Requirements" the following requirements are established: "low-voltage equipment must be designed and manufactured in order to provide the following when using it according to its intended purpose and meeting the requirements for its installation, operation:
required level of protection against the direct and indirect electric current exposure;
absence of impermissible risk of high temperatures, arc discharges or radiation which can cause the hazards occurrence;
required level of protection against the hazards of non-electric origin, … including the hazards caused by physical … factors".
"List of Low-Voltage Equipment Which Is Subject to Confirmation in the Form of Certification in Accordance with the Technical Rules of Custom Union on Safety of Low-Voltage Equipment" exists as Appendix to the document [22] (hereinafter, "List of LVE"). The List of LVE contains 9 items by the groups of products which are subject to the mandatory certification. LPs can refer to the following groups:
"1. Electric apparatus and devices for household use" (subgroups: "gaming, sport and training equipment" and "audio and video equipment, receivers of TV and radio broadcasting").
"2. Personal computers" (hereinafter PC).
"3. Low-voltage equipment connected to the personal computers" (for instance, laser printers).
Concerning "audio and video equipment", practically all such equipment operates using the laser semiconductor diodes (LSD). LSDs are included into the structure of many PCs. Currently LSDs are applied in the "sport and training equipment" as well.
In addition to the document [22] there is "List of Standards Application of Which Results in Compliance with the Requirements of Technical Rules of Custom Union on Safety of Low-Voltage Equipment" (hereinafter, "List of Standards of LVE").
The standards GOST R IEC-1 [10] and STB IEC 60825-1 -2011 [24] are given in the List of Standards of LVE under No. 294. In the published papers [1-3] it is established that application of GOST R IEC-1 within the territory of the Russian Federation is illegitimate due to its contradiction relative to the requirements of USHR-2010 [21] and SNs [4]. Moreover, the application of GOST R IEC-1 within the territory of the Russian Federation is essentially illegitimate due to its non-compliance with the requirements of FL No. 184 and FL No. 52. Standard of the Republic of Belarus STB IEC 60825-1 – 2011 cannot be applied within the territory of the Russian Federation for the same reasons as GOST R IEC-1. The following question arises: how is it possible to confirm the safety of LPs and different types of LVE which use LPs and compliance with the requirements [22] when carrying out the mandatory or voluntary certification?
The following paragraph is in Clause 7 Paragraph 2 [22] "Confirmation of Compliance":
"In case of failure to apply the standards specified in Clause 6 Paragraph 1 (in other words, specified in the List of Standards of LVE) of these technical rules of Custom Union or in case of their absence the confirmation of compliance of low-voltage equipment is performed in the form of certification (schemes 1c, 3c, 4c) in accordance with Paragraph 10 of this clause".
Thus, currently well-grounded refusal to apply GOST R IEC-1 does not allow confirming the compliance of LPs with the requirements [22] in the form of compliance declaration for the developer but it allows undergoing more complicated procedure of LP certification with the involvement of authorized certification bodies.
Clause 7 Paragraph 10 states that in case described in Clause 7 Paragraph 2, "manufacturer …, importer provides to the certification authority … the package of low-voltage equipment documents" confirming the compliance of LVE with the requirements of this document [22] which includes specifications, operating procedures, description of adopted technical solutions and "assessment of risks which confirms the fulfillment of requirements" of this document [22].
Thus, currently when refusing to apply GOST R IEC-1 it is sufficient to provide the confirmation of the product compliance with the requirements of USHR-2010 [21], in other words, to submit the simple calculation to the certification authority confirming that upon the assessment of compliance with the LS requirements tighter standards of MPL were used (including the situations when determining CLs) than upon use of GOST R IEC-1. This calculation is essentially the actual assessment of hazard level or assessment of actual risk of laser radiation generated by certifiable LP or any other certifiable LVE which contains LP.
Let us briefly consider the document [23]. There are following terms in Clause 2 "Definitions" of the document:
"Machine is the number of interconnected parts and units where at least one part or unit moves with the help of the relevant drives, control circuits, energy sources integrated for the specific use …";
"Equipment is the technical device applicable separately or installable on machine which is necessary for the performance of main and/or additional functions …".
Such expanded interpretation of the term "equipment" makes it possible to use it for any laser product (which undoubtedly is the "technical device") designated for carrying out any individual technical operations and for the LP which is built in the "machine" and favors to the performance of the main and additional functions of the "machine". Rather wide range of existing LPs can be referred to such "laser equipment" (LE). Let us note that upon the use of the requirements [23] as opposed to the requirements [22] in relation to LPs the supply voltage required for the LP operation is not important.
There are two lists of technical regulation subjects (TRS) for which the confirmation of compliance with the requirements [23] is compulsory: the list of TRSs which are subject to the confirmation of compliance in the form of certification (hereinafter, "List of TRSs 1) and list of TRSs which are subject to the confirmation of compliance in the form of compliance declaration (hereinafter, "List of TRSs 2).
There are 15 items in the List of TRSs 1 by the groups of products. According to our estimates the use of LPs in the specified groups is unlikely. There are 60 items in the List of TRSs 2 by the groups of products. We paid attention to several items where LPs can be used:
"23. Woodworking equipment (except for woodworking machines)";
"25. Equipment for welding and thermal spraying";
"41. Processing equipment for light industry";
"42. Processing equipment for textile industry".
Some laser machining systems (LMS) refer to these types of products. For example, LMSs for laser welding (p. 25); LMSs for the formation of openings and sections with complex shapes in different wood materials using laser beam (LB) (p. 23); LMSs for cutting of different materials and textile using LB (p. 41, p. 42).
There is Appendix No. 1 to the document [23] "Main Requirements for the Safety of Machines and/or Equipment" and it has the following paragraph:
"57. When using the laser equipment the following actions must be performed:
Accidental radiation must be prevented;
Protection against direct, reflected, scattered and secondary radiation must be provided;
Absence of hazard from optical equipment must be provided for the observation or adjustment of laser equipment".
Presence of Paragraph 57 confirms that developers [23] assumed beforehand that any laser equipment (LE) used separately as well as in different machines (in other words, in devices with actuated parts) came within the requirements of these technical rules. Of course, those types of LE which did not come within the List of TRSs 2 can undergo the voluntary procedures of certification or declaration of compliance with the requirements [23].
In addition to the document [23] there is "List of Standards Application of Which on Voluntary Basis Results in Compliance with the Requirements of Technical Rules of Custom Union on Safety of Machines and Equipment" (hereinafter, "List of Standards of ME").
The section "Standards of Group B (Group Issues of Safety)" in the List of Standards of ME gives the only standard which relates to LS. This is the main standard of existing traditional national system of LS – GOST 12.1.040 – 83 "Standards System of Labor Safety. Laser Safety. General Provisions" [6].
In our opinion, developers of the document [23] and List of Standards of ME as opposed to developers of the document [22] and List of Standards of LVE stood for the correct opinion giving preference to the national standard on LS [6]. As a result of such solution currently there are no problems when confirming the compliance of LP (LE) with the requirements [23] with any form of confirmation.
This may be due to the fact that there is p. 3.1 in GOST 12.1.040 [6] where the following statement is directly given: "maximum permissible levels of laser radiation, … are determined in accordance with the requirements of Sanitary Norms and Rules of Lasers Structure and Operation". Besides, p. 2.3 of this standard regulates 4 classes of LPs by the hazard level of LPs which are identical to the classes regulated in USHR-2010 and SN 5804-91.
Finishing the consideration of new technical rules of Custom Union ([22] and [23]) we can assert that currently practically all LPs can undergo the certification in order to confirm the compliance with the requirements [22] or requirements [23]. In other words, currently there is operating mechanism of safety confirmation of practically every LP and receipt of the relevant documentary evidence.
Thus, for the period to the end of 2016, in other words, up to the enforcement date of individual technical rules on LS provided by the "road-map" the documents [22] or [23] should be used for the confirmation of quality and safety of laser products. Herewith, currently the issue on creation of new system of LS standards should be solved in the first place which will replace the system of standards GOST R IEC 60825 and standards GOST R 54836, GOST R 54838 – GOST R 54842 within the territory of the Russian Federation and CU. Also the new system of standards must replace the outdated national technical regulatory system on LS. Of course, new standards should rely on the current norms of LS and CL regulated in USHR-2010 [21] or SN 5804 as amended. Herewith, the new standards should use different reliable and beneficial provisions of the standards IEC and ISO to the maximum extent possible (except for the MPL values and classification levels of LPs).
The main purpose for the development of new standards is to provide the regulatory system [22] and [23] with up-to-date and effective regulatory documents on LS. Herewith, the task of provision of regulatory system of Custom Union LS technical rules scheduled by the road-map of photonics development will be simultaneously solved. Development of these technical rules of Custom Union can be performed simultaneously with the development of new standards but it should not advance it.
In the following part of the review we will present a number of suggestions for the new system of national standards on laser safety.
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