What will the User Manual Template help you to achieve?

CE marking

CE marking compliance

Medical Devices

Medical Devices Directive compliance

IEC 82079

IEC 82079 compliance

ANSI Z535.6 ISO 3864

ISO 3864 and ANSI Z535.6 compliance

CE marking compliance

A user manual’s function is to explain to the user how a product can be used safely and correctly. The user manual informs the user about risks that still persist, despite the adoption of measures for inherent safe design, safeguarding and complementary protection. Failure to warn the user properly can make the manufacturer liable in case of any accidents. That’s why the duty to warn/provide instructions with the products is regulated and often mandatory. The User Manual Template is a MS Word file that contains all mandatory elements, as required by CE marking and other relevant European product safety directives, to create your own compliant manual for the EU market. 


Medical Devices Directive compliance

The Directive for Medical Devices gives requirements on the content of the user instructions, called the Essential Requirements. The User Manual Template contains all these mandatory elements that are placed in the right position, so you know exactly what to add and where to add it in order to create a compliant manual. Besides CE marking directives, other directives might apply to your product, such as the WEEE, REACH, packaging or battery directive. These directives also give requirements on the information that needs to be provided with the product, mostly related to safe disposal. The User Manual Template contains ready-to-use texts to comply with these requirements.

See what our customers have to say...

Lothar Naujokat
Director
HANNETS

“The User Manual Template helped our engineers to create the user manuals for our latest product. It contains all the information you need to create your own compliant manuals, so you don’t have to outsource this! It is such a time saver!”

Philip Olsson
CEO
ISOVOX Sweden

“The factory manuals always need to be redone. This was a daunting task for us: we never knew where to begin and at the end we were not sure if the manual did comply. The User Manual Template provides us all relevant information so we can create compliant instructions and decrease our liability.”

IEC 82079 compliance

The EN IEC 82079-1:2012 Preparation of instructions for use is an international standard that provides both general principles and detailed requirements for the design and formulation of all types of user instructions. The standard has been harmonised by the EU, which means that by applying the standard you create the highest level of presumption of conformity with the Essential Requirements of the Directives. The User Manual Template contains all elements as provided by the 82079 that can be easily adjusted to your own needs. The table of contents of the User Manual Template is based on the content requirements as given by this internationally recognised standard.


ISO 3864 and ANSI Z535.6 compliance

The ISO 3864 standard specifies international standards for safety symbols, including the formatting of the DANGER, WARNING, CAUTION safety symbol panels. The ANSI Z535.6 also describes the formatting of these, but also gives requirements on when to use which warning level, where to place safety messages throughout the manual and how to use words like shall, could and may. The User Manual Template has adopted the requirements from this standard, so you will be able to create compliant safety instructions.