by Motion Controls and Drives Team, Kollmorgen
Safety has been a hot topic in automation and motion control—and the publication of EU Machinery Directive 2006/42/EC has focused more attention on the subject. Here’s what machine builders need to know about this and other safety directives—and the five most common myths about them.
Also known as the EC machinery safety directive, EU Machinery Directive 2006/42/EC covers aspects of nearly all machines—including lifting hoists, mobile equipment, machine tools, and medical and packaging equipment. The standard seeks to harmonize machine safety requirements across this entire machine range.
In fact, the EU as a whole ratifies directives. Then each member country is expected to implement its own local laws, regulations, and standards to enforce directived. So all are subject to interpretation by lawmakers, regulatory authorities, standards organizations and companies that design and use machinery.
There are two alternative European standards from the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) in compliance with EU Machinery Directive 2006/42/EC. These are EN ISO 13849-1 and EN 62061.
ISO 13849-1 provides safety requirements and guidance on the principles for the design and integration of safety-related parts into controls. EN 62061 is a machine-specific standard within the IEC 61508 framework for designing electrical safety systems. With many different organizations and individuals involved in interpreting and implementing the directive, it’s not surprising that confusion and erroneous interpretations have arisen. This article will address five specific myths about the EU directive and explain the related impact on builders and users of machinery.
Background on safety
Machine builders and operators need to understand current safety standards, but that’s a frustrating task because new standards have instilled fear in the industrial-machinery market. Navigating the requirements is complicated, partly because myths about the standards abound. So, some organizations now take conservative approaches to integrating safety—or worse yet, completely avoid it.
In fact, machine safety is the responsibility of OEMs, end users and technology vendors as a whole. No single standard or law guides anyone completely through the process. Because so much of the machine safety is left up to those involved in the design, integration, and use of a machine, it is important to take an empowered role in getting it right.
1. Myth: ISO 13849 and IEC 61508 are laws
ISO 13849 and IEC 61508 are standards rather than laws. Only the EC machinery safety directive itself can be considered a law. In most cases, countries enforce the machinery directive and other directives through regulatory authorities that perform a similar function to the Occupational Health and Safety Administration (OSHA) in the U.S. The machinery directive does not apply to U.S. end users directly, but could apply if an OEM is building and exporting to an EU country.
The ISO 13849 standard provides guidelines for machine builders to comply with the EU machine directive, so it is a valuable standard to observe. ISO 13849 is intended to empower machine builders to use creative design practices to improve machine safety, but in many cases it has encouraged rigidity due to fear of making mistakes.
Standards are intended to keep industry professionals aligned with requirements and to eliminate uncertainty. They are not supposed to encourage strict adherence to specific design practices. OEMs have the power and responsibility to make decisions about machine suitability within the standards.
Risk assessment is the core tenant of all machine safety standards. It’s important to follow a process, produce a rating system and base the design on it. Standards don’t explicitly clarify how to rank each hazard or how to rank various mitigation options. The important part is to define and adhere to an acceptable product development process.
2. Myth: U.S. and EU standards are different
ANSI/PMMI 155 and ANSI B11.0 are the main U.S. standards addressing machinery safety; they both follow the same core principles as EU standards, such as ISO 13849. Furthermore, other standards can be used to comply with the machinery directive without contradicting ISO 13849.
Organizations such as the Packaging Machinery Manufacturers Institute (PMMI), American National Standards Institute (ANSI), and Robotics Institute of America (RIA) have drafted standards that allow builders to comply with the machinery directive. ANSI/PMMI B155.1-2011 (B155.1) was actually drafted more recently than the current ISO 13849, and it was written specifically to harmonize with modifications expected in the next revision of ISO 13849.
The bottom line is that machinery builders have flexibility in how they design machines. Existing machine designs are, in many cases, adequate to meet modern safety guidelines. The design of many safety components has not changed significantly with these new standards. They have simply been validated and categorized in accordance with the new standards. Many vendors can offer mean-time-to-fail dangerously (MTTF d) measurements for standard components. Builders can use this data to calculate the overall effectiveness of a machine safety system concurrent with any modern standard they desire. It is smart for designers to follow current standards because these are considered state of the art, but it does not automatically presume that a traditional safety method is not proper.
Core principles like risk assessment are common to all current and former standards. The risk assessment sets the performance levels of the safety systems. The builder should evaluate the current system architecture, analyze the safety chain and determine if the current design meets the newly determined performance levels. A good design can meet multiple standards and machine manufacturers can use one risk assessment to demonstrate compliance with multiple standards. Requirements such as safety labelling can be different for different standards, but these conflicts are usually relatively minor.
3. Myth: Category levels for safety are no longer applicable
Machinery manufacturers are accustomed to designing control systems based on EN954-1 categories. When the EU machinery directive was updated in 2006, it designated EN954-1 as no longer valid and not to be used by machinery builders. This incorrectly led many builders and control systems providers to believe that the safety category levels are no longer applicable or appropriate. However, ISO 13849 still places significant importance on category levels in determining the performance level of safety systems. The category levels have not changed in the new EU machinery directive. Categories ratings are still the core principle of a safety function.
The new requirements demand additional calculations to define performance or safety integration levels. These factors include diagnostic coverage, common cause failures and reliability of the hardware determined by the parameter MTTFd. The new approach to both ISO 13849 and IEC 62061 centers on component reliability and system coverage calculations rather than purely architectural determinations of overall machine safety. Safety vendors are providing data to help with these system calculations. Current architectures based on adherence to the EN954-1 standard can easily be brought into compliance with the new directive. It will most likely not change the core architecture of your safety system. Note the new standards are still based on the safety architecture described in the well-known categories and in addition, the probability of a failure has to be considered to determine the safety level.
4. Myth: The emergency stop is a safety feature
From IEC60204-1 (section 22.214.171.124.1) Safety of Machinery – Electrical equipment of machines: “Emergency stop and emergency switching off are complementary protective measures that are not primary means of risk reduction for hazards (for example trapping, entanglement, electric shock or burn) at a machine (see ISO 12100) …”
Many standards, including NFPA 79 of the U.S. National Electrical Code, reference the need for an emergency stop. IEC60204-1 and NFPA 79 are generally aligned in the area of emergency-stop requirements. But all machines pose risks, and an emergency stop doesn’t make a machine safe. Functional safety aims to reduce the operational risks associated with machines. Emergency stops are designed for unplanned occurrences. Modern safety standards spur safety systems that respond properly without the need for emergency intervention.
So, OEMs and integrators often ask: What is the required safety level of the emergency-stop function? The answer depends on the residual hazard left in the machine.
Evaluation starts with a risk assessment. Severity and exposure are determined during the risk assessment and directly relate to the safety integration level (IEC 61508) or performance level (ISO 13984). A key consideration is that severity and exposure is based on the residual hazard. This is the hazard left after other risk mitigation steps have been taken. This could require design changes, hard guarding, or control reliability based interlocks applied to eliminate or reduce the hazard. The takeaway is that the emergency stop may be in the Safety Integration Level 2 (SIL2) or PLd realm of required safety level. For example, since a redundant control reliable safety interlock eliminates personnel from exposure to a hazard, the emergency stop only has to guard against residual risk. Since the exposure is low, an SIL2 or PLd safety level is appropriate. An emergency stop requires human intervention so it is not a reliable way of reducing risk or eliminating a hazard. The primary effort should go into reducing hazards without the intervention of personnel.
5. Myth: OSHA recognizes and enforces the EU machinery directive or ISO or IEC standards
OSHA has its own standards, so the EU machinery directive and ISO and IEC standards are not applicable to machines sold for use in the U.S.
OSHA 29CFR1910 contains both general requirements and specific machine level requirements. These requirements have changed minimally in comparison with international standards. It is entirely possible for machine builders to design machines that comply with both OSHA requirements and the EC machinery directive.
The most controversial difference in OSHA standard is for the Control of Hazardous Energy Lockout/Tagout (LOTO) 29 CFR 1910.147. LOTO, as it is defined in the OHSA standard, is a mandatory requirement and one that can seem to limit some of the freedoms afforded by designers using functional safety standards. A key section highlighting a potential conflict between standards is as follows:
1910.147(a)(2)(ii)(B): An employee is required to place any part of his or her body into an area on a machine or piece of equipment where work is actually performed upon the material being processed (point of operation) or where an associated danger zone exists during a machine operating cycle.
Note that there’s an exception to paragraph (a)(2)(ii). This standard does not cover minor tool changes and adjustments and other minor servicing activities that take place during normal production operations if they are routine, repetitive and integral to the use of the equipment for production … provided that there are measures that provide effective protection. (See Subpart O of this Part.)
Many builders and operators are currently wrestling with the interpretation of “minor changes and adjustments.” Modern safety systems and standards make for environments where personnel can be kept safe using active controls rather than traditional LOTO. Control systems using safe-limited-speed (SLS) functions let operators perform tasks without the removal of energy.
Determining if a task is minor or routine is beyond the scope of this article, but an example of a potential source of conflict is changing a die out of a machine. If the die must be swapped frequently, an operator may consider this routine fairly minor from their business perspective … but OSHA may feel differently. In fact, OSHA offers 10 different interpretations here, so there’s no definitive guide on LOTO or how modern systems using reliable safety solutions should address LOTO requirements. For such situations, U.S. machine operators and those providing machines to U.S. operators hope to get more guidance soon.