Declarations

LINAK participates in shared responsibility and cooperative efforts in the international movement of hazardous chemicals, in order to improve the protection of human health and the environment by complying with relevant chemical regulations.

LINAK is committed to providing our customers with products meeting a high standard of innovation, performance and environmental safety. This high standard of compliance is also set as a requirement for our suppliers.
Achieving this target requires the ability to quickly adapt to the following environmental regulations, directives, and conventions:

REACH
The Registration, Evaluation and Authorization of Chemicals regulation is a European regulation on chemicals. LINAK supports the objectives of the REACH (Regulation (EC) No 1907/2006) and complies with the following regulations:

  • Candidate List of SVHCs
  • REACH Annex XIV – Authorization list
  • REACH Annex XVII – Restriction List

The European Chemicals Agency (ECHA) added Lead to the Candidate List of Substances of Very High Concern (SVHC), on June 27, 2018. (www.echa.europa.eu/web/guest/candidate-list-table).

A part of the LINAK product range is affected by this inclusion, meaning that Lead is contained in some products with a concentration above 0.1% (w/w).
Where reasonably technically possible, LINAK aims to substitute Lead in our products.

Read more about the REACH statement from LINAK, here.

RoHS
Reduction of Hazardous Substances (RoHS) is a European directive (Directive 2011/65/EU) that restricts the use of hazardous substances in electrical and electronic equipment. At LINAK, we are continuously monitoring new coming regulations in the EU RoHS directive. All LINAK products are RoHS compliant at all times.

Read more about the current valid RoHS statement from LINAK, here.

Battery Directive
The Battery Directive (2006/66/EC) establishes rules regarding placing batteries, accumulators, and waste batteries on the market containing hazardous substances. It also establishes specific rules for the collection, treatment, recycling and discarding of waste batteries and accumulators. LINAK complies with and meets all obligations related to this directive, including marking batteries with crossed-out wheelie-bin and chemical signs: Pb (lead), Cd (cadmium) and/or Hg (mercury) – according to which chemical that exists in which battery, above the threshold.

Proposition 65
Proposition 65 (Safe Drinking Water and Toxic Enforcement Act of 1986) is a California law that requires businesses to notify Californians about significant chemicals that cause cancer or birth defects or other reproductive harm. Through analysis of item specifications, internal and external data gathering, LINAK has identified a number of products that currently require a warning label to be applied when shipping to California.

Read more about the Proposition 65 statement from LINAK, here.

Medical Devices Regulation (MDR)
The MDR entered into force on May 25, 2017 and it has been applicable since May 26, 2020.

LINAK products are not classified as medical electrical equipment or systems, nor do they fall within the scope of the EU Medical Device Directive/Regulation or other similar national regulations. The products are components to be built into a piece of medical electrical equipment by a manufacturer. However, we acknowledge the need for medical device manufacturers to be informed about substance content.

The MDR requires the manufacturer of medical devices to state whether the medical device contains Latex or not. Regarding Latex, we can advise, to the best of our knowledge, that none of our MEDLINE products contain this substance.

As this is an ongoing process, we will continue to advise about progress in a timely manner.

POP
POPs (Commission Regulation (EU) No 1342/2014) on Persistent Organic Pollutants/Stockholm Convention, is a list of chemical substances posing a risk of causing adverse effects to human health and the environment.
LINAK complies with the chemical substances listed in the POP regulation.

Minamata Convention on Mercury
LINAK is subject to The Minamata Convention on Mercury, as signed by Denmark on October 10, 2013 and approved on May 18, 2017. Therefore, LINAK complies with this convention that aims to protect human health and the environment from releases of mercury and mercury compounds.

LVD
The Low Voltage Directive (LVD) (2014/35/EU) ensures that electrical equipment within certain voltage limits provides a high level of protection for European citizens. It has been applicable since April 20, 2016. LINAK is impacted by and therefore complies with the LVD directive.

EMC
The Electromagnetic Compatibility (EMC) (Directive 2014/30/EU) ensures that electrical and electronic equipment does not generate, or is not affected by, electromagnetic disturbance. LINAK is impacted by and therefore complies with the EMC directive.

IECEx / ATEX
ATEX is an EU directive (2014/34/EU) governed by the EU, while IECEx is a leading standard, both of which concern requirements for equipment intended for use in potentially explosive atmospheres. LINAK actuators for the explosion-protected (Ex) industry comply with the IECEx standard and ATEX directive.

Packaging and packaging waste directive
LINAK declares that our basic packaging method is cardboard boxes on disposable pallets, heat treated according to IPPC standard ISPM No. 15, and complies with the Packaging and packaging waste directives 2018/852, 2004/12/EC and the amendment 94/62/EC. See statement in QA-16-09-008.

Biocompatibilty
LINAK MEDLINE® & CARELINE® products, intended to be incorporated into electrical medical equipment and systems, comply with IEC 60601-1:2012 clause 11.7. All parts of the products, that in normal use can come into contact with the skin surface of the patient or the user, are assessed. Assessment is according to postmarked experience and the nature and duration of their anticipated contact with human tissues when in use. The assessment is based on LINAK products being non-invasive and in touch with intact skin only. Declaration of Biocompatibility.pdf

Misc. Declarations

How LINAK ensures Component Compliance
LINAK makes all reasonable efforts to ensure appropriate and timely handling of updates in the directive and regulations. Responsibilities and appropriate resources have been assigned to enable us to comply, and LINAK has set up a procedure to handle and ensure chemical compliance. As a part of this procedure, LINAK uses a third-party data management solution to gather information. This information is provided by suppliers in the form of declarations, which are then uploaded in the aforementioned database and monitored by us regularly.

If you need more information or have other requests regarding chemical compliance, please contact chemicalcompliance@linak.com 

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