In Europe, a manufacturer can use European harmonised standards to comply with CE-directives and accordingly affix the CE marking. Safety companies in North America, like UL, have their own standards, which have to be taken into account when exporting to the US. Standards related to instructions of use may be similar but also vary depending on the market where you intend to place your product. Let’s take a look at the American ANSI Z535.6 standard.
Regulation in the EU and US
Regulation in the European Union
The EU has developed effective instruments to stimulate the free circulation of goods and the safe use of products. One major step was the harmonization of legislation across the EU through the so called New Approach Directives. The directives set out the fundamental requirements that products must comply with, which are related to health, safety, consumer and environmental protection. Products that are placed on the Community market, whether produced within the European Union or in a third country, must meet the requirements of the applicable directives. The technical requirements are not included in the directives, but in the harmonised standards.
While it is mandatory to comply with the directives, the application of standards remains voluntary. This gives manufacturers the freedom of choice. However, by applying harmonised standards, the manufacturer achieves a presumption of conformity with the requirements. Furthermore, the manufacturer benefits from a series of choices when it comes to performing the conformity assessment. For certain products it is mandatory to involve a Notified Body in the conformity assessment, while for other products manufacturers may perform the process in their own right.
In Europe, there are several Notified Bodies that manufacturers can choose from. TüV, Bureau Veritas, Lloyd’s Register, BSI or SGS are just a few examples. When it comes to instructions for use, the European harmonized standard EN-ISO-82079-1 can be used for developing adequate instructions which meet the requirements from the CE directives.
Regulation in the US
In the US safety and health in general is being regulated by the OSHA. The OSHA regulations are federal regulations. The OSHA approves both standards and testing institutes. Approved standards can be part of the regulations.
When exporting to the US, it can be mandatory that a product is tested by a testing institute, like UL, FM Global or MET Labs. For electrical equipment for example, OSHA has made it mandatory the equipment to be tested and approved to an applicable standard (e.g. the NFPA 70) by a recognized laboratory.
US courts interpreting and applying product liability laws generally hold that product manufacturers have a legal duty to warn about hazards associated with the use or maintenance of their products. In so doing, US courts look to see what state of the art standards exist in the industry affected. In the US 80% of the claims are based on defect of marking, i.e. failure to warn.
When it comes to instructions for use, the following state of the art standards are most applied:
- IEC: 82079-1 Preparation of instructions for use (international standard)
- ISO/ IEC Guide 37:2012 Instructions for use of products by consumers (international standard)
- ANSI Z535.6 Product Safety Information in Product Manuals, Instructions, and Other Collateral Materials (American national standard)
Differences between EU and US
The IEC 82079-1 is a standard published by the International Electrotechnical Commission. The standards has been harmonised in the European Union (EN-ISO 82079-1) and is being considered as a state of the art standard in the US. To anticipate on the huge amount of claims based on defect of marking, the ANSI Z535.6 has been developed to set forth guidelines for safety messages. It is this standard that makes the difference when it comes to standards for instructions for use. However ISO developed the ISO 3864-2 (and this standard has been adopted by some European countries) this standard has not been harmonized in the EU. This means a European opponent of the ANSI Z535.6 does not exist.
Besides general differences in the way safety and health has been regulated, the main difference when it comes to standards for information for use is the ANSI Z535.6. By using the ANSI Z535.6 and for example the IEC 82079-1, it is possible to develop instructions for use that will comply with the US requirements.
Why is there a standard for safety messages?
As safety messages on product safety signs and safety information found in collateral materials can differ, the ANSI standard sets forth a way of communicating that is developed specifically for product safety information in collateral materials. This standard provides guidelines that need to be followed when creating collateral materials. Collateral materials are defined in the standard as printed information that comes with the product, like a manual, user instructions or other materials containing safety messages.
How does a safety message look like?
A safety message can contain a signal word, like DANGER, WARNING or CAUTION, in combination with the sign of a triangle containing an exclamation mark (the so called safety alert symbol). The message can be presented in black/white, or according the colours specified in ANSI Z535.1. The standard defines the type, style and size of the signal words as well.
Signal word panel examples
The signal word panel (or in some cases just the safety alert symbol) and the conveyed safety message together, form the safety message as it can be used in collateral materials.
Safety Alert Symbol + Signal Word = Signal Word Panel
Signal Word Panel + Conveyed Safety Message = Safety Message for use in collateral materials
What types of safety messages are there and where do I put them in my manual?
The ANSI Z353.6 gives four types of safety messages:
- Grouped safety messages
- Section Safety messages
- Embedded safety messages
- Supplemental directives
Grouped, section and embedded safety messages should identify hazards, give an indication how to avoid them and explain the consequences when not avoiding the hazards (e.g. “ Highly corrosive chemicals. Risk of severe eye and skin injuries. Avoid contact. Wear eyes and body protection”).
Grouped safety messages need to be provided in a separate chapter or in a different document, are more general of 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, e.g. with the specific task to which the embedded safety message applies.
Supplemental directives may often be generic. For example:
- General safety implications of a document (e.g. “read all instructions before use to avoid injury”)
- Generic messages regarding the handling of safety information e.g. “Keep these instructions for future reference”)
- General safety implications of grouped safety messages (e.g. “to avoid serious injury, follow the safety information in this section”)
The right place to place supplemental directives is in the introduction part of a document. The supplemental directives can contain a safety alert symbol with or without a signal word panel.
Now how do I use the ANSI Z.535.7 in my manual creation process?
- Determine the hazards posed by the product
- Determine the conveyed message that describes the hazard-type and the evasive or avoidance actions
- Determine the corresponding safety alert symbol, and the need for a signal word panel
- Determine the signal word (CAUTION or DANGER etc.)
- Determine the best location of the safety messages
This is a compact summary of ANSI Z535.6. If you want to read more about safety messages, you can learn more by ordering the full standard at www.ansi.org. If you want to know more about standards regarding Instructions for use in general (structure, content and presentation), order the IEC 82079-1.
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