Standards and directives

EN ISO 80601-2-56 Particular requirements for the safety, including essential performance, of medical thermometers for measuring body temperature.

EN 60601-1: Medical electrical equipment – Part 1: General requirements for safety, including essential performance.

EN ISO 14971: Medical devices – Application of risk management to medical devices.

EN ISO 10993-1: Biological evaluation of medical devices – Part 1: Assessment and verification under a risk management system.

EN 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for safety, including essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests.

EN 980: Symbols for use in the labeling of medical devices.

EN 60601-1-11: Medical electrical equipment – Part 1-11: General requirements for safety, including essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems for household medical use.

This product complies with the provisions of the EC Directive 93/42/EEC.

For MEDICAL ELECTRIC DEVICES, special precautions must be taken with regard to electromagnetic compatibility (EMC). For detailed information on EMC requirements, please contact your authorized service center.

Portable and mobile HF communication devices can interfere with MEDICAL ELECTROGENES.

2014/53 EV Radio equipment directive.

FCC ACCORDING INFORMATION AND STATEMENTS

User Information according to FCC 15.21:
Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

Statement according to. FCC 15.19
This device contains license-exempt transmitter(s)/receiver(s) that complies with FCC Part 15 and Innovation, Science and Economic Development Canada’s license-exempt RSS. Operation is subject to the following two conditions:

(1) this device may not cause interference, and
(2) this device must accept any interference received, including interference that may cause undesired operation.

Statement according to. RSS GEN Issue 5:
This device contains license-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canada’s license-exempt RSS.

Operation is subject to the following two conditions:
L’émetteur/récepteur exempt de licence contenu dans le pré­sent appareil est conforme aux CNR d’Innovation, Sciences et Développement économique Canada applicables aux appa­reils radio exempts de licence. L‘exploitation est autorisée aux deux conditions suivantes:

(1) this device may not cause interference, and
(1) l‘appareil ne doit pas produire de brouillage, et

(2) this device must accept any interference received, including interference that may cause undesired opera-tion.
(2) l‘utilisateur de l‘appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est sus­ceptible d‘en compromettre le fonctionnement.

Updated on 27. January 2021

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