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Conformities

Conformities & Declarations

All of our chairs are medical devices which are registered with the MHRA and adhere to their regulations. For more specific standards and accreditations, please see below.

Basic UDI-DI:

732184D0059X

Risk class (Regulation (EU) 2017/745 Annex VIII)

Class I

Intended use:

The product series comprises modular patient seats designed to be used together with primary clinical examination equipment, such as Xray machines. The device is intended to be used in conjunction with other medical devices in environments and situations that may require adjustable seat positions for different patients to make it possible to conduct the examination efficiently and with satisfactory results. Applicable situations include, but are not limited to, mammography and other X-ray examinations, as well as various kinds of ophthalmological examinations. The chairs are designed to be used wherever a good, seated position is required, such as the following situations: - the patient has to withstand a full examination. - the patient needs support to remain sufficiently motionless in order for the examination method to give satisfactory results. - the patient needs support to remain sufficiently motionless during a biopsy, for example. - being able to carry out a more efficient examination in order to reduce the time during which the patient needs to endure an emotional strain, as can be experienced in mammography, for example. This product series is designed to be operated by a professional who ensures an appropriate adjustment in relation to both the patient and the primary examination equipment.

Regulatory Frameworks

The product identified in section 1 Product identification above conform to the provisions of the EU regulations, EC directives, UK regulations and Swedish national legislations below:

  • Regulation (EU) 2017/745 Medical Devices

  • Regulation (EC) No 1907/2006 Chemical Substances (REACH)

  • Directive 2011/65/EU Restriction of Hazardous Substances (RoHS)

  • Directive 2012/19/EU Waste Electrical and Electronic Equipment (WEEE)

  • Swedish legislation SFS 1993:584

  • Swedish legislation LVFS 2003:11

  • The Medical Devices Regulations 2002 (UK MDR 2002)

  • The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012

Standards of Conformity

EN ISO 21856:2022 IEC 60601-1:2005 + A1 +A2 EN 20417:2021 EN 10993-1:2009 EN 1335-1:2000 EN 1335-2:2018 EN ISO 14971:2020/A11:2021 EN 50581:2012 EN ISO 15223-1:2021

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