Certification and Classification of Products:
Newmed has developed a Quality Management System in accordance with the requirements of international standards and is controlled by annual audits of the notified body. The company owns the certifications according to the following standards: ISO 9001 and ISO 13485. A copy is available upon request.
Newmed is focused on the quality of the product and processes, aiming to satisfy customer needs and expectations. Newmed’s products are medical devices with CE certification and comply with the requirements of Directive 93/42 / EEC and its amendments.
Safety is the first priority in Newmed, and so all steam sterilizers are compliant with the following mandatory and voluntary technical standards and regulations:
- EU Directive 93/42/EEC (medical devices)
- EU Directive 2006/42/EEC (machines)
- EU Directive 2014/68/UE (pressure equipment)
- EU Directive 2014/30/UE (EMC)
- EU Directive 2014/35/UE (LVD)
- UNI EN 13060:2015 (Small Steam Sterilizers)
- CEI EN 61010-1:2013 and CEI EN 61010-2-40:2016 (laboratory equipment)
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