Product certification
7990044_030_10 – 2078511 – 2023-01-19 93
11 Product certification
11.1 European Union
The operating table is a Class I medical device according to
Regulation 2017/745/EU concerning medical devices, and is
compliant with the version of the regulation currently in force at
the time of product sale. Baxter declares the conformity of the
operating table with the essential safety and performance
requirements according to Regulation 2017/745/EU concerning
medical devices, Annex I. A conformity assessment procedure
required for Class I devices shall be carried out in accordance with
Article 52 (7), taking into account a quality management system in
accordance with Annex IX, Chapter 1. The manufacturer certifies
conformity with the CE marking.
11.2 USA/Canada
ETL mark: Intertek tested the product for the USA and Canada.
ETL classification regarding risk of electric shock and fire, as well
as mechanical hazard in accordance with ULSTD 60601-1; CAN/
CSA STD C22.2 NO.60601-1.
11.3 Ukraine
Це маркування підтверджуЕ, що вироби, промарковані знаком
відповідності, пройшли всі необхідні процедури підтвердження
відповідності та підкоряються визначенимтехнічним керівництвам
України.
Відповідність: Технічний регламент щодо медичних виробів,
затверджений Постановою Кабінету міністрів України від 02 жовтня
2013 р. N° 753
11.4 Serbia
Certificate / registration number 515-02-03704-16-001
11.5 EAEU
This product has passed all conformity assessment procedures
(proof) specified in technical regulations as part of regular
customs procedures for assessment of conformity (proof), and
furthermore complies with all industrial regulations. It is approved
in the following countries: Armenia, Belarus, Kazakhstan,
Kyrgyzstan, Russia.
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