Since 1993, the Conformite Europeene (CE) mandatory mark has signified conformance with legal and technical directives put forth by the European Union (EU). This CE mark has served as an entry stamp for many industrial products and services certifying that the producer of the product or service complies with health, safety, and/or environmental requirements. Altogether, there are around 25 directives requiring the CE mark certifying such areas as: safety, machinery, low-voltage equipment, terminal equipment, and electromagnetic compatibility.
Many manufacturers understand and comply with existing CE marking, but not all manufacturers are fully aware, and many more are not prepared, to conform with the looming new Machinery Directive set to become effective on December 29, 2009. Manufacturers must understand that there are significant changes from the current directive, Machinery Directive 89/392/EEC to the new directive, Machinery Directive 2006/42/EC.
For manufacturers planning to compete with machinery sales into the European marketplace, it will be essential to become well versed in the new requirements and follow up with action plans for product compliance.
Machinery Directive: What's New
The evolving requirements stipulated by the new Machinery Directive provide users and suppliers of machinery with guidelines for prevention of serious injury.
Some key changes include:
Process of Risk Assessment - Machine manufacturers are obligated to complete a risk assessment that is now defined within the directive as an iterative process of hazard identification, risk estimation, hazard elimination or risk reduction.
Safety system requirements - Machine designers are obligated to design control systems in such a way that a fault in the hardware or software of the control system and/or reasonably foreseeable human error does not lead to hazardous situations.
Harmonized standards - The standard governing the design and implementation of the safety related parts of control systems on machinery (EN 954-1) becomes obsolete on December 29, 2009. Machine builders must use EN ISO 13849 or EN/IEC 62061 to achieve compliance with the new directive.
Administrative and Assessment Procedures - New assessment procedures are defined for machines listed in Annex IV of the directive and for "partly completed machines". For manufacturers of Annex IV machines self-certification is now possible.
Machine builders outside the EU - Machine builders outside the EU must authorize a person who must be established in the Community to compile the technical file for the machine. Machine builders without an operation in the EU can appoint an "Authorized Representative".
Structural changes to the new Machinery Directive expand language to include more detailed instruction, dictate changes in essential requirements, provide greater scope under administrative procedures, and even review definitions of machinery.
For example, under 3.1.3 Control Systems and Devices, the obligations on machine control system designers are more explicitly and in some cases more stringently defined. In the main these requirements restate with clarity that a failure of or any other cause in a machine control system should not lead to a hazardous situation. However the requirement to consider "foreseeable human error" is new. The design of the safety system must be considered in a manner where machine operators do not benefit or gain incentive from bypassing safety systems. Recognizing advances in technology the new directive introduces the obligation to consider control systems and protective devices to automatically prevent start-up if it detects a person in a danger zone.
Or, under 3.3.1. Boundary with Low Voltage Directive, the interpretation of the "Low Voltage Directive" ("LVD") and the existing "Machinery Directive" resulted in the unintentional exclusion from the machinery directive of machines on which it could be claimed that the hazards were primarily electrical. In certain cases such an interpretation resulted in only the LVD being applied. This "loophole" is now closed by specifically listing in the new MD the electrical and electronic products which are covered by the LVD as opposed to the new Machinery Directive.
In addition to final products or services, assemblies of machines such as robot cells and production lines also fall under obligations of the new Machine Directive.
Clearly, the new Machine Directive provides meaningful expansion to existing requirements. Manufacturers must heed the expanded changes and ensure their products and services fully comply with the significantly more stringent standards.