CE MARKING DIRECTIVES AND REGULATIONS

CE Marking certifies that the product meets EU safety, health, and environmental protection standards, ensuring market access and boosting consumer trust. The "CE" mark indicates that the product may be traded freely in any part of the European Economic Area, regardless of its country of origin.

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CE-Marking Certification

DIRECTIVES AND REGULATIONS

Surgical Instruments Materials – Metals (BS EN ISO 7153-1:2016)

The BS EN ISO 7153-1:2016 standard specifies the metallic materials used in surgical instruments ensuring high durability, corrosion resistance, and biocompatibility. Compliance guarantees instrument reliability, patient safety, and adherence to global healthcare standards

Electromagnetic Compatibility (EMC) Directive 2014/30/EU

The PPE Regulation (EU) 2016/425 ensures that personal protective equipment meets strict health, safety, and performance standards in the European market. Compliance guarantees user protection, legal market access, and enhanced product reliability.

Radio Equipment Directive (2014/53/EU) (RED)

The Machinery Regulation (EU) 2023/1230 sets essential safety and performance requirements for machinery and industrial

equipment in the European market. Compliance ensures worker safety, legal market entry, and alignment with modern

technological advancements.

General Product Safety Regulation (EU) 2023/988

The General Product Safety Regulation (EU) 2023/988 ensures that consumer products meet high safety standards before entering the EU market. Compliance enhances consumer protection, minimizes risks, and strengthens market trust in product reliability.

Protective Clothing for Abrasive Blasting Operations – ISO 14877

The ISO 14877 standard specifies requirements for protective clothing used in abrasive blasting operations ensuring worker safety

against airborne particles, impact, and exposure risks. Compliance enhances durability, comfort, and protection in hazardous environments.

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