Sets forth requirements for the design and location of product safety messages in collateral materials for a variety of products. Your Alert Profile lists the documents that will be monitored. If the document is revised or amended, you will be notified by email. You may delete a document from your Alert Profile at any time.

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In this article, I will show you how I create compliant user manuals for the US market. And I am able to do this based on or simultaneously with the European documentation, with a minimum of extra time and effort. I will outline the strategy in detail. Using the method, which I have named the U. You will:. Together, the enabling acts and laws and the final regulations provide a framework for the implementation and enforcement of most federal laws in the United States.

The Health and Body group oversees agencies that cover alcohol, tobacco, food, and cosmetics. Vehicles is the watchdog for categories such as aircraft, automobiles, watercraft, amusement park rides, and child car seats.

Hazard-Safety-Firearms covers the agencies that administer ammunition, radioactive materials, commercial and industrial products, and more.

The nature and characteristics of the product or situation determine which Federal Agency is involved. The goal of the CPSC is to provide consumers protection against any unreasonable risk of life-threatening injury or death from products under its jurisdiction.

The CPSC has jurisdiction over thousands of types of consumer products used at home, in schools, in recreation, or otherwise. CPSC attempts to achieve the goal to protect the public against unreasonable risks of injuries and deaths associated with consumer products through education, mandatory safety standards activities, developing and publishing regulations, enforcement of the statutes and, if necessary, banning products.

When Congress has enacted a law, the federal agencies often develop or use existing standards to implement the law. Section of the CPSIA requires every manufacturer or importer of consumer products that must comply with the rules set forth by CPSC to create certificates stating the product is in compliance with each regulation, standard, or ban.

Voluntary standards can provide product-specific requirements regarding instructions. Apart from product specific mandatory and voluntary standards, there are some commonly used international standards that set out requirements for just the instructions for use.

Now that you have an overview of both the mandatory and voluntary standards and the standards for user instructions, it is time to acquire and search them to find the specific requirements on the instructions.

Figure 1: Requirement from the F standard. The United States has not established common law and has set no product liability regulation. All 50 states have individual standards that define product liability. The typical scenario is that liability claims fall into the following situations:. Furthermore, most states have some form of consumer protective statute. The risk utility test tries to balance the utility of the product against the risks of its specific design.

A product may be deemed defective on the basis of:. Typical warning defects arise where:. The test for defects in design and warnings and instructions is very subjective and based on reasonableness factors to be decided by a jury. Determining when there is a duty to warn or instruct and how far that duty extends is a difficult question that every manufacturer needs to answer.

The final manufacturer, the manufacturer of individual components of the product, or the importer may be liable under a strict product liability claim for damage caused by a defective product. In the US, as well as in the EU product strict liability claims, the causation standard applies that the injured person must prove beyond reasonable doubt that the injury was a direct result of a defect in the product.

This can be similarly stated as the warnings are inadequate when risks of product harm that should have been foreseen could have been mitigated or avoided by providing reasonable instructions or warnings, and the omission renders the product not reasonably safe. The fact that adequate instructions are provided, assisting the operator in the correct operation of the product, does not necessarily discharge the duty to provide an adequate warning.

A warning may still be required to call attention to the dangers of using the product. The purpose of instructions is to provide reliable information to consumers as to the proper ways to safely consume or use the products. Warnings should effectively alert all consumers to any risks associated with product use.

Obviously, warnings are usually negative statements regarding what to avoid or affirmative statements about things always to do. Instructions tend to describe in more detail how to do something safely and correctly. Federal agencies like the CPSA require importers, manufacturers, distributors, and retailers of consumer products to report product risks. Specifically, these entities must immediately report any information that leads to a reasonable conclusion that the product in question is not compliant with CPSC regulations, or is defective in a manner that would possibly create a significant hazard including the risk of significant injury or death.

As an example, under Section 15 b of the Consumer Product Safety Act CPSA , manufacturers, importers, distributors, and retailers are required to report to CPSC within 24 hours of obtaining information, which reasonably supports the conclusion that an unregulated product does not comply with a safety rule issued under the CPSA, or contains a defect which could create a substantial risk of injury to the public or presents an unreasonable risk of serious injury or death.

Because of the importance of warnings in the US, a specific standard has been developed dealing with the content, location and the ways warnings are presented: ANSI Z ANSI Z For these purposes, collateral materials are defined as any printed documentation accompanying a product, such as manuals, safety warnings, instruction pamphlets, etc. The signal word and safety alert symbol are placed in a so-called signal word panel.

The standard defines the type, style and size of the signal words as well, see Figure 2. Together the signal word panel or in some cases just the safety alert symbol and the conveyed safety message form the safety message as it can be used in collateral materials, see Figure 3.

Risk of severe eye and skin injuries. Avoid contact. Grouped safety messages need to be provided in a separate chapter or in a different document. They are more general in nature and apply to the entire document. Section safety messages are placed in the first part of the specific section to which they apply. Embedded safety messages have to be integrated with the non-safety messages, for example, with the specific task to which the embedded safety message applies.

Supplemental directives , normally placed in the introduction of a document, may often be generic. In the EU, a manufacturer can use European harmonised standards to comply with the relevant essential health and safety specifications of CE directives for marking with that marking affixed accordingly.

Even though similarities exist, complying with product directives within the US is slightly different from the process of EU compliance. By following the steps of the methods described, you should be able to create compliant documentation for the US market. Eager to help organisations to reduce their product liability.

Just loves cooking, travel, and music--especially electronic. I see it as our duty together to emphasise the positive environmental benefits of digital information. You can help by sharing or liking this blog post. In this podcast, I am interviewing Jens-Uwe Heuer-James, a renowned lawyer, specialising in product liability and product safety, particularly on topics such as CE conformity evaluation and technical documentation Do you want a compliant user manual for your machinery, electrical equipment, toys or medical device?

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To provide CE marking , a manufacturer can use European harmonised standards to comply with the CE-directives. When exporting to the US, certification companies like UL apply their own standards. How do you deal with the American market when it comes to your instructions for use? To remove the barriers to free circulation of goods and to protect consumers and other users of all kinds of products, the European Union has developed, and still develops, tremendous effective instruments.


American standards regarding instructions for use

ANSI Z is an American standard that sets forth a system for presenting safety and accident prevention information. It corresponds to the international ISO standard. The ANSI Z standards are administered and published by NEMA the National Electrical Manufacturers Association , an association of member companies that manufacture a diverse set of products including power transmission and distribution equipment, lighting systems, factory automation and control systems, and medical diagnostic imaging systems. This committee is a highly active United States standards-making body that writes these standards to govern the characteristics of visual safety markings that are used to warn about hazards and prevent accidents.


High voltage… biohazard… wet floor… radioactive materials… the effectiveness of safety signs like these relies upon consistency and bold, graphic impact to warn people against specific hazards and personal injury. ANSI Z Reorganized to more clearly describe the five types of safety signs used in facilities, the edition has also been updated to better harmonize with other parts of the ANSI Z series. Revisions to the standard include a new product safety sign, as well as updated definitions to more clearly delineate a separation between physical injury and other safety-related issues. Access Standards. About ANSI.

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