Applying standards correctly means knowing and understanding them. Also, to know their limits and scope of regulation, as well as the relationship to other relevant standards.
This particularly applies to standards such as EN ISO 20607:2019, Safety of machinery - Instruction handbook - General drafting principles. But why is it like that?
For many years, standardization bodies have dealt with the subject of technical documentation and communication, so the Association of German Engineers (VDI) with its VDI 4500 Sheet 1 -4, Technical Documentation. At European level, we were previously familiar with Edition 1 of EN 82079-1:2032 (successor standard to EN 62079: 2001, note). This standard was already replaced in spring 2019 by Edition 2 of ISO / IEC / IEEE 82079-1: 2019, Preparation of information for use (instructions for use) of products - Part 1: Principles and general requirements. The 82079-1 Ed. 2 is a horizontal standard for all types of products, regardless of whether these products are electrically driven or not. Contrary to the incorrect interpretation that the standard only applies to electrical products, the standard is also applicable for machinerys.
In ISO / IEC / IEEE 82079-1 according to the state-of-the terms, it´s spoken about information for use instead of instructions for use.
ISO / IEC / IEEE 82079-1 is a basic normative tool for technical writers because it standardizes things that are important in technical communication: target groups, expression, structure, processes, qualifications, information conception (types of information, development of information products and their editions) etc.
Now another standard from the corner of ISO (International Organization for Standardization) has come into the focus. As already reported in various publications, ISO 20607 has been in place for operating instructions for machinery since spring 2019 (this also includes systems, i.e. a set of machinery and incomplete machinery note). A standard that reduces itself within the scope to the 'safety-relevant parts' of 'operating instructions.
Nothing more is needed, because the rest is already covered in ISO / IEC / IEEE 82079-1: 2019 and other established international standards.
In addition, for the sake of completeness, it should be noted that information for use (also for machinery note) is much more than just 'operating instructions'. This small part is now dealt in EN ISO 20607.
Official Journal European Union (OJEU) - List of presumed standards
Since around one year the European Union has been publishing changes to harmonized standards for their guidelines in the Official Journal. For the last time, these standards for the EC directive for machines were updated with the implementation decision 2020/480 of the European Commission (EC) on April 1st, 2020.
As already announced many times, it was the intention of ISO Working Group 5 of the Technical Committee 199, General principles for the design of machinery and risk assessment, to list EN ISO 20607 as a harmonized standard for the EC Machinery Directive. At the beginning of the work on this standard, this was a stated goal, which has now been achieved with the current implementing decision.EN ISO 20607: 2019 has now been listed in line 66 of Annex I to the Implementing Decision.
EN ISO 20607: 2019 has now been listed in line 66 of Annex I to the Implementing Decision.
At this point attention is required. Because not as originally expected, only parts of this standard trigger this presumption.
With the application of EN ISO 20607, only the requirements of section 18.104.22.168, excl. Point u) (information on noise emissions, note) of the EC Machinery Directive 2006/42/EC are considered to be fulfilled. These are:
22.214.171.124. Contents of the instructions Each instruction manual must contain, where applicable, at least the following information:
a) the business name and full address of the manufacturer and of his authorized representative;
b) the designation of the machinery as marked on the machinery itself, except for the serial number (see section 1.7.3);
c) the EC declaration of conformity, or a document setting out the contents of the EC declaration of conformity, showing the particulars of the machinery, not necessarily including the serial number and the signature;
d) a general description of the machinery;
e) the drawings, diagrams, descriptions and explanations necessary for the use, maintenance and repair of the machinery and for checking its correct functioning;
f) a description of the workstation(s) likely to be occupied by operators;
g) a description of the intended use of the machinery;
h) warnings concerning ways in which the machinery must not be used that experience has shown might occur;
i) assembly, installation and connection instructions, including drawings, diagrams and the means of attachment and the designation of the chassis or installation on which the machinery is to be mounted;
j) instructions relating to installation and assembly for reducing noise or vibration;
k) instructions for the putting into service and use of the machinery and, if necessary, instructions for the training of operators;
l) information about the residual risks that remain despite the inherent safe design measures, safeguarding and complementary protective measures adopted;
m) instructions on the protective measures to be taken by the user, including, where appropriate, the personal protective equipment to be provided;
n) the essential characteristics of tools which may be fitted to the machinery;
o) the conditions in which the machinery meets the requirement of stability during use, transportation, assembly, dismantling when out of service, testing or foreseeable breakdowns;
p) instructions with a view to ensuring that transport, handling and storage operations can be made safely, giving the mass of the machinery and of its various parts where these are regularly to be transported separately;
q) the operating method to be followed in the event of accident or breakdown; if a blockage is likely to occur, the operating method to be followed so as to enable the equipment to be safely unblocked;
r) the description of the adjustment and maintenance operations that should be carried out by the user and the preventive maintenance measures that should be observed;
s) instructions designed to enable adjustment and maintenance to be carried out safely, including the protective measures that should be taken during these operations;
t) the specifications of the spare parts to be used, when these affect the health and safety of operators;
u) the following information on airborne noise emissions: — the A-weighted emission sound pressure level at workstations, where this exceeds 70 dB(A); where this level does not exceed 70 dB(A), this fact must be indicated, — the peak C-weighted instantaneous sound pressure value at workstations, where this exceeds 63 Pa (130 dB in relation to 20 µPa), — the A-weighted sound power level emitted by the machinery, where the A-weighted emission sound pressure level at workstations exceeds 80 dB(A). These values must be either those actually measured for the machinery in question or those established on the basis of measurements taken for technically comparable machinery which is representative of the machinery to be produced. In the case of very large machinery, instead of the A-weighted sound power level, the A-weighted emission sound pressure levels at specified positions around the machinery may be indicated. Where the harmonized standards are not applied, sound levels must be measured using the most appropriate method for the machinery. Whenever sound emission values are indicated the uncertainties surrounding these values must be specified. The operating conditions of the machinery during measurement and the measuring methods used must be described. Where the workstation(s) are undefined or cannot be defined, A-weighted sound pressure levels must be measured at a distance of 1 meter from the surface of the machinery and at a height of 1,6 meters from the floor or access platform. The position and value of the maximum sound pressure must be indicated. Where specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels, those Directives must be applied and the corresponding provisions of this section shall not apply;
v) where machinery is likely to emit non-ionizing radiation, which may cause harm to persons, in particular persons with active or non-active implantable medical devices, information concerning the radiation emitted for the operator and exposed persons.
Extract from DIRECTIVE 2006/42/EC OF THE EUROPEAN PARLIAMENT AND THE COUNCIL
So, what`s in EN ISO 20607: 2019?
The new standard was created as a type-B standard as an aid for machine manufacturers, so that they can create legally compliant operating instructions and act 'compliant' to the requirements of the machine directive.
As already mentioned, an operating manual is only one element of the information for use of a machine. This is covered by the ISO / IEC / IEEE 82079-1 which is much more extensive and more in-depth about this topic.
EN ISO 20607 regulates in section 4, 'Principles and general information', whereby section 4.11, is dealing with information for use relating to IT vulnerabilities, which is also excluded from the presumption of conformity.
The standard refers to ISO / TR 22100-4 Guidance to machinery manufacturers for consideration of related IT-security (cyber security) aspects, which was published in Dec. 2018 as a technical rule to EN ISO 12100:2013 and specifically comes in to the topic of IT Security.
In section 4, the standard also refers to the important section 6.3 'Design and development, including review, editing and testing' of ISO / IEC / IEEE 82079-1. Another aspect that shows, that it´s reasonable to work with both standards.
In section 5, EN ISO 20607 regulates the content and structure of the operating instructions. Here, the standard provides a kind of 'cooking recipe' for the structure or content of an operating manual, but makes it clear that this is only a recommendation and should serve as a guide. Machine manufacturers or technical editors in mechanical engineering must therefore continue to decide independently which actual structure fits their information products. The proven ISO / IEC / IEEE 82079-1: 2019 provides more comprehensive approaches.
What is the point and purpose of EN ISO 20607?
The standard contains a pragmatic specification of the requirements from EN ISO 12100: 2013 section 6.4 and can be understood and applied without extensive knowledge of technical documentation and communication. This is not the case with ISO / IEC / IEEE 82079-1, which requires in-depth concept work, a well-organized information creation processes, and expertise in creating information for use.
EN ISO 20607 is about basic specifications for operating instructions of machinery - an important aspect for many mechanical engineering companies. In this case, the standard can be seen as a helpful instrument. It supports companies without specialist staff or without their own technical writing team. With the standard, companies receive more or less a 'guide' with which they raise their operating instructions to a tolerable minimum level and prepare them in accordance with the applicable legal requirements.
But it has to be admitted that the standard does not provide comprehensive answers to in-depth questions for technical writers. This can already be seen in the warning notices, where the standard in Section 6.5 only gives a brief note on how to draw up according to the tried and tested SAFE principle (signal word, anticipated type and source of the hazard, foreseeable consequences of disregard, escape from the hazardous situation, note) . A categorization is completely lacking, as provided in ISO / IEC / IEEE 82079-1 or even from ANSI Z535.
When applying EN ISO 20607, it is important that critical overlaps or contradictions to ISO / IEC / IEEE 82079-1 have now been eliminated so that you can deal well with both standards. At first it appeared that there will be conflicts in the application in a kind of double standardization. The responsible committee has corrected these problem areas, sometimes not for the benefit of EN ISO 20607 and has frequently referred to ISO / IEC / IEEE 820791-1.
Thus, the answer to the question of the application of EN ISO 20607 is already in place:
If companies (machine manufacturers, note) are not yet able to meet the normative and far-reaching requirements of ISO / IEC / IEEE 82079-1 Edition 2, it makes sense to apply EN ISO 20607, which is now harmonized to the Machinery Directive. This affects above all those companies that have not yet any trained technical communicator in their team. As an alternative, you can also get external know-how by service providers on board.
However, in order to remain competitive in this area for the future, a company should strive to build up the processes and management systems required in ISO / IEC / IEEE 82079-1 Edition 2. Technical documentation or communication represents a not inconsiderable proportion of past, current and possibly future product liability cases and is becoming increasingly important in the eyes of law. Instruction errors (also failure of adequately warn; note) are becoming a topic of controversy and also whether the instructions have met the users' security expectations. This is a topic where professionals are needed. And they exist!
Mention of EN ISO 20607 in the declaration of conformity
If EN ISO 20607, like many other standards, is applied in product manufacturing, this must be listed under the harmonized standards for the Machinery Directive. The same conditions apply here as for other standards.
Machine manufacturers, if they have applied the standard, can also name ISO / IEC / IEEE 82079-1 in the section of non-harmonized standards. But caution should be used here again, because the standard demands a lot from product manufacturers in the areas of processes, concept work, specialist competence and management. To mention this standard simply cannot be listed without awareness of the consequences, a standard should only be listed in the declaration of conformity if it is fulfilled.
Digital / electronic operating instructions
There is a connection between EN ISO 20607 and ISO / IEC / IEEE 82079-1 when providing information for use across various (including digital / electronic, note) media and channels. Although the scope of regulation of EN ISO 20607 is only limited to operating instructions, the possibilities listed therein are interesting, especially after the harmonization to the EC Machinery Directive 2006/42/EC.
The well-known, heavily discussed and legally ambiguous consensus to provide relevant information of safety and health protection, only in paper form, is adapted to the state of the art by EN ISO 20607. ISO / IEC / IEEE 82079-1 also enables different media to be selected that suit the product and the users (target group, note).
These would be:
- Provision of printed operating instructions
- Provision on an electronic storage medium
- Provision by access to external servers, websites or other storage options, for example cloud storage
- Provision on internal servers or storage media
- Provision as audio or video instructions on control terminals, on websites, as sound files or on the Internet
Originally, the aim was to legalize the possibility of providing operating instructions in digital/electronical form in the course of harmonization. This is not the case now and therefore the specification of the standard must be observed accordingly. EN ISO 20607 refers to the observance of the applicable legal requirements in relation to the provision of the instructions for use. In the EU, these are now still the requirements from the Machinery Directive (and the EU Blue Guide).
The Blue Guide (it’s just a guide; note) in particular requires, that safety -relevant information must be provided in paper form. The fact that this point is also controversial on the legal side and measured against the state of the art remains the subject of further developments in legislation. Efforts are underway to ensure that the digital provision of information for use is introduced as part of the revision of the Machinery Directive and is thus legalized. It remains to be hoped for.
In the normative part of EN ISO 20607, reference is made to compliance with contractual requirements, only if there are no legal provisions for the provision of the operating instructions. This may could require the digital provision of information for use. Machine manufacturers should act together with experts for product conformity and product liability and if necessary, consult legal advice.
Likewise, regarding the language version, EN ISO 20607 refers to the applicable legal provisions in the respective target country.
EN ISO 20607 makes it easier to enter the world of technical communication, although this new standard is not a world championship achievement. ISO / IEC / IEEE 82079-1 Edition 2 is a technical standard that goes deeply into processes for creation and management. Therefore, professionals in technical communication primarily apply the horizontal standard and carry out a comparison with EN ISO 20607. Mechanical engineering companies should learn to work with these two standards in parallel.
EN ISO 20607: Can be used for simple and quick 'dishes' ... that means simple operating instructions without having to bring extensive specialist knowledge to the technical writing team..
ISO / IEC / IEEE 82079-1: Comprehensive scope of regulation, advancing deeply into the core of technical communication. It requires knowledge of information development and needs concept work.
Mechanical engineering companies are well advised to start simply and then become more complex. This means that you first meet the few requirements of EN ISO 20607 and then dedicate to ISO / IEC / IEEE 82079-1. With increasing competence in technical communication, EN ISO 20607 may only function as a normative "sidecar" in the future, due to its limited scope of regulations.
Posted on: 22.04.2020
Managing Director of CAVEO Safety Management & Documentation. Industrial engineer, technical editor, safety specialist and expert for technical safety and documentation. Board member of tekom Austria. Participation in national and international standards committees. Lecturer in the master's course in technical documentation at the FH Joanneum. Author in technical publications and speaker at international conferences.