International Center for Quality Certification - ICQC
Skolas 63-19, Jūrmala, Latvija, LV-2016
Phone +371 203 99 443 (WhatsApp Viber) Email office@icqc.lv, kovalev@icqc.lv
Notified Body number: 2549

Differences in conformity assessment of machines and mechanisms in the EU and the US.

European standardisation is based on the principle that manufacturers are responsible for the safety of their products throughout their entire life cycle. Risk assessment, technical documentation and a declaration of conformity form the basis for , which is a requirement of the Machinery Directive for the sale and use of machinery in the European Economic Area. The CE marking serves as proof that the machine complies with all the essential health and safety requirements laid down in the regulation and has undergone the appropriate testing and assessment.

 

In the United States, machine safety regulation differs from the use of European standards systems. There is no single central system in the United States that requires all manufacturers to comply with legislation, as the system consists of several different standards and regulations from regulatory bodies. The most commonly used reference systems are the ANSI B11 series of standards and the OSHA standards of occupational safety authorities.

 

The American National Standards Institute (ANSI) is a voluntary standardisation organisation whose purpose is to develop safety standards for industry and to define requirements related to the safety of machinery and equipment. Compliance with ANSI standards is not mandatory, but they are often referenced in contractual requirements as they can play an important role in demonstrating the safety of equipment.

The Occupational Safety and Health Administration (OSHA) determines that employers are responsible for maintaining a safe workplace and ensuring that workers are not exposed to serious risks and illnesses while working or as a result of using the equipment used. The Occupational Safety and Health Administration has the authority to conduct inspections in connection with workplace accidents.

Unlike European legislation, where the primary responsibility lies with the equipment manufacturer, in North America it is primarily directed at employers and equipment users. OSHA regulations emphasise technical solutions and precise safety requirements, which is reflected in the structure of the standards. The difference between the legislation is that in Europe, the regulations are based on general design principles and a risk management system.

The difference in the application of regulations in Europe and other market areas concerns the placing of machinery on the market.

North America does not have a labelling system similar to that in the European Economic Area. To verify compliance, equipment may need to be placed on the market by a third-party testing laboratory. The purpose of the laboratory is to test and certify products to confirm compliance with ANSI and OSHA requirements at an approved level. Since standardisation is decentralised, approval procedures may vary from state to state.

Local authorities or regulatory inspectors may also intervene in the approval process for individual devices. If a CE-marked device is not listed by an NRTL or the device's standards do not meet North American safety requirements, the regulatory inspector has the authority to reject the device and require additional testing or third-party verification before it can be put into service. Although the CE marking is proof of compliance in Europe, it does not mean that the device is approved in the United States. Differences in standards may vary depending on the economic region and lead to differences in the safety and marketing of machines.

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