Labels in accordance with DIN EN 60601-1 for medical technology
The EN 60601 is the row of standards which deals with the safety and essential performance features of medical electrical equipment like e.g. resistance to chemicals. It is the technical equivalent to the international standard IEC 60601-1.
The “basic standard” EN 60601-1 covers the safety and the essential performance features of all medical electrical equipment, while the standard EN 60601-2-xx, also called “particular standard”, refers to particular product groups (e.g. EN 60601-2-22 for medical laser devices).
The EN 60601-1 applies to all medical electrical equipment and medical electrical systems. In this standard the electrical equipment is considered as medical electrical equipment when it has an application unit and transfers energy to or from the patient or registers such an energy transfer from or to the patient and is equipped with a connection to a supply network as well as is designated in accordance with the definition of the manufacturer for diagnosis, treatment or observance of the patient or for the relief of a disease, injury or disability.
This row of standards also imposes the requirements to resistance and the test requirements regarding the labeling products of the equipment and systems.
The main features
- High resistance against chemicals and solvents
- High abrasion resistance with suitable thermal transfer ribbons
- Labeling in accordance with the standard DIN EN 60601-1 in individual formats and special forms
- Very high adhesive power even on difficult substrates
- Additional safety functions like security cut-outs possible
- Special materials by Avery, 3M, Flexcon, and Tesa are available from stock
Functions and advantages
- The labels have been developed especially for the use on medical equipment
- Almost unlimited application durability indoors
- Permanently adhesive and suitable for the adhesion onto powder coated substrates and slightly oily substrates.
- High mechanical resistance of the available material combinations
- Perfectly suitable for the labeling of laboratory and analytical equipment
The standard-compliant labels offer the most possible flexibility and will be tailored individually to customer’s requirement. This happens by using suitable special materials of leading manufacturers, individual die-cutting forms and premium adhesives.
The labels can be inscribed directly as required in variable amounts with current data at the site, by that the storage and the management of numerous labels may be dropped.
Our upscale and accurate processing with most modern die-cutting technologies guarantees the highest precision and reliability for the label application. Thus even plain labels with adhesives which are difficult to process can be processed mechanically very well, which increases the user efficiency in the long term.
Frequently Asked Questions
Warning labels, inspection plates, and type plates for all medical electrical equipment and medical electrical systems, like e.g.:
- Ambulance service equipment
- High frequency surgical devices
- Incubators and heaters for the newborns
- Medical laser
- Patient displays
- Patient respiratory apparats
- Therapeutic and diagnostic sonographic devices
- Temperature resistance from -40°C (-40°F) to +150° C (302° F)
- Smear resistance in accordance with DIN EN 0601-1 against e.g. isopropanol, hydrochloric acid 32%, spirit, premium gasoline, diesel, cold cleaners, engine oil 15W-40 and further chemicals
- Durability for outdoor application up to 5 years
- Durability for indoor application almost unlimited
- High performance materials made from acrylate and polyimide foils, aluminum foil and polyester (PET)
- Permanent/repositionable/removable adhesives with a very good adhesive power for high- and low-energy substrates
- Diverse carrier materials like compressed kraft paper in different thicknesses, transparent plastic liner, kraft paper siliconized on both sides, and environmentally stable kraft paper available
- Subsequently inscribable with thermal transfer printing, laser engraving, and inkjet printing method
- Foil features are from soft and smooth and stretchy to stable and tear-proof
Material composites, adhesive-free zones as well as partially preprinted logotypes are also possible.
As a manufacturer robos-labels has a wide range of already approved and certified labeling solutions. When additional customized licenses are required, we can take on the approval- and certification process if desired.
We already meet the following standards and regulations with our raw materials:
- DIN EN 0601-1 Safety requirements and ergonomic requirements for medical electric equipment/systems
- UL969 Marking and labeling systems (labels on smooth and not convex surfaces)
- UL817 Safety cord sets and power supply cords
- UL2238 Cable assemblies and fittings for industrial control and signal distribution
- UL94 Flammability of plastic materials for parts in devices and appliances (UL VTM-0 strictest classification)
- FMVSS 302 Evaluation of the flammability of interior materials (flammability/burn rate)
- BS 5609 Label resistance to saline sea water
- Directive 2014/34/EU (ATEX directive) Harmonization of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres
- DIN EN ISO 11683:1997-11 Packaging – Tactile warnings of danger – Requirements
- ADR 2021 Ordinance on the transport of dangerous goods by road, rail and inland waterways (GGVSEB)