Declaration of Conformity, Statements and Certificates

Ascom Wireless Solutions products are designed to conform to a large number of standards, including but not limited to harmonized standards under applicable EU directives. Testing is performed internally at Ascom and/or by third party test houses.

Certificates etc. relating to local markets are located under Test Reports in the menu.

Declarations of Conformity related to applicable EU Directives, Compliance Statements and ATEX & IECEx Certificates on EX-approved equipment are available. 

How to download pdf-documents:
Point at the relevant link, right click and select "Save Target As".

RoHS Directive Statement: Ascom (Sweden) AB hereby declares that our products do not contain, above legal threshold limits, any of the restricted substances in directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment.

Battery Directive Statement: Ascom (Sweden) AB hereby ensures that our provided batteries fulfil the requirements of Directive 2006/66/EC (the 'Battery Directive'), Le.: 

• No button cells contain more than 2% mercury by weight;
• No other batteries or accumulators contain more than 0,0005% of mercury by weight; and
• No other batteries or accumulators contain more than 0,002% cadmium by weight;

We also acknowledge our obligation to be a registered producer (as defined by the directive) and has since 31 March 2010 reported quantities of sold and collected batteries, as well as reported compliance with the above mentioned directive on labelling of batteries, collection schemes and information provided to end-users.

REACH Regulation Statement:  Ascom is committed to making an effort to ensure that all Ascom products manufactured in or imported into the European Union are in compliance with the EU's REACH legislation and will therefore continue to work closely with our Suppliers in order to get available and relevant information from our suppliers.

Obligations under Article 33 of the REACH Regulation
According to Article 33 of the REACH Regulation, we will as soon as we gain knowledge of any substances of very high concern (SVHC) as specified in the latest update of ECHAS candidate list in concentrations over 0.1% in our products, comply with the disclosure duty for information. For more details see "REACH Complaince Statement"   

General Statement of Compliance

We hereby confirm that Ascom Wireless Solutions' design and development process for Medical Devices complies with at least the following standards:

• ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes
• ISO 14971 Medical devices - Application of risk management to medical devices
• IEC 80001-1 Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities
• IEC 62366 Medical devices - Application of usability engineering to medical devices
• IEC 62304 Medical device software - Software life-cycle processes

MEDICAL DEVICES Incident Reporting to Vigilance Team

Anyone who becomes aware of a manufactured device-related serious injury, death, or malfunction shall notify the Vigilance Coordinator by fax, phone or E-mail, within 24 hours.

Preferred contact: vigilance@ascom.se

If the preferred email address is used, applicable NCR number shall be stated first in the subject field.

Any supporting documents for reportable events shall be immediately forwarded to the Vigilance Coordinator.

Hazardous Location Reporting

Anyone that becomes aware of any malfunction or suspected non-conforming EX product shall file a Helpdesk application.

Link Support

In the case of suspected damage, do not use the EX classified devices in hazardous area

.