Next How do I comply my manual with American standards? 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? Directives and standards 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. These directives contain fundamental requirements regarding health, safety, environment and consumer protection.
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Check the list of Federal Agencies to find out if your product is in another jurisdiction. Note: If you know the jurisdiction but your product is not on the lists of regulated products, you most likely market an unregulated product.
Unregulated products do not have standards or bans. For all unregulated products you must report defective or dangerous products. Step 3: Identify which standards are mandatory for your product. 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.
Product specific standards may include requirements regarding the instructions for use. To identify which standards are mandatory for your product: Go to the website of the relevant federal agency for example, www. Click on the hyperlink in the right column.
The following page opens: www. Mandatory standards in the US are free available. Step 4: Identify which standards are voluntary for your product. Voluntary standards can provide product-specific requirements regarding instructions.
To identify which standards are voluntary for your product: Go to the website of the relevant federal agency for example, www. Step 5: Identify the minimum specific requirements for adequate 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. Purchase the relevant standard. Step 6: Verify the product-specific requirements from both the voluntary and mandatory standards.
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.
To identify the requirements on the instructions: Acquire the relevant standards s. Type labelling to find the requirements regarding the labelling. Figure 1: Requirement from the F standard. Do you want a compliant user manual for your machinery, electrical equipment, toys or medical device? All 50 states have individual standards that define product liability. The typical scenario is that liability claims fall into the following situations: specific liability theory is there a product defect, regardless of whether there was negligence on the part of the manufacturer?
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: a manufacturing defect a design defect a warning defect. Typical warning defects arise where: Inadequate for example, unclear or incomplete warnings or instructions are given; The foreseeable danger of the product might have been minimised or avoided if the manufacturer or another person responsible for the product compliance had provided reasonable warnings or instructions; The failure to provide such warnings or instructions rendered the product not reasonably safe.
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. Case Law According to case law, a manufacturer has a duty to warn where: the product is dangerous; the danger is or should be known by the manufacturer; the danger is present when the product is used in the usual and expected manner; and the danger is not obvious or well-known to the user.
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. Requirement to report 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.
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.
American standards regarding instructions for use
ANSI Z535: Standards for Safety Signs and Labels