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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 that meet 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:

The Registration, Evaluation and Authorisation 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 – Authorisation list
  • REACH Annex XVII – Restriction List

The European Chemicals Agency (ECHA) added Lead on the Candidate List of Substances of Very High Concern (SVHC), on 27 June 2018. (

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 of LINAK.

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 of LINAK.

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 threshold.

Proposition 65
Proposition 65 (Safe Drinking Water and Toxic Enforcement Act of 1986) is a Californian law that requires businesses to notify Californians about significant chemicals that cause cancer or birth defects or other reproductive harm. Through the 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 of LINAK.

Medical Devices Regulation (MDR)
The MDR entered into force on 25 May 2017 and has been in force since 26 May 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 inform, to the best of our knowledge, that none of our MEDLINE products contain this substance.

As this is an ongoing process, we will provide information about progress in a timely manner.

POPs (Commission Regulation (EU) No 2019/1021 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 10 October 2013 and approved on 18 May 2017. Therefore, LINAK complies with this convention that aims to protect human health and the environment from releases of mercury and mercury compounds.

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 20 April 2016. LINAK is impacted by and therefore complies with the LVD directive.

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.

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, comply with the Packaging and packaging waste directives 2018/852, 2004/12/EC and the amendment in 94/62/EC. See statement in QA-16-09-008.

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 t 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 anticipated contact with human tissues when in use. The assessment is based on LINAK products being non-invasive and in contact with intact skin only. Declaration of Biocompatibility.pdf

MD (The Machinery Directive) 2006/42/EC, Annex II B, Declaration of Incorporation of Partly Completed Machinery and Assembly Instruction

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 the suppliers in the form of declarations, which are then uploaded in the afore-mentioned database and monitored by us regularly.

If you need more information or have other requests regarding chemical compliance, please contact 

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