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6 Posts in this encyclopedia categoryImporter
Importer is defined under MDR (EU) 2017/745 as any natural or legal person established in the EEA who places a medical device from a third country on the EU market. The importer has specific verification and documentation obligations and must ensure the manufacturer has fulfilled their regulatory duties.
ISO 13688
EN ISO 13688 is the base standard for protective clothing, setting general requirements for ergonomics, innocuousness, size designation, ageing, marking and manufacturer information. It contains no protective performance of its own and is always applied together with a product-specific standard.
ISO 14001
ISO 14001 is the international standard for environmental management systems (EMS). It sets requirements that organisations can meet to improve their environmental performance and comply with environmental legal obligations. In the glove and PPE sector, increasingly required by customers as a sustainability credential.
ISO 16603
ISO 16603 specifies the test method for determining the resistance of protective clothing materials to penetration by blood and body fluids, using synthetic blood as the test medium. Testing is carried out at six pressure levels and serves to select the test pressure for ISO 16604.
ISO 16604
ISO 16604 specifies the test method for determining the resistance of protective clothing materials to penetration by blood-borne pathogens, using the bacteriophage Phi-X174 as a surrogate. It underpins viral protection evidence under EN 14126 and is methodologically identical to the glove test in EN ISO 374-5.
ISO 18889
ISO 18889 sets performance requirements and test methods for protective gloves used when handling pesticides. It recognises that pesticides exist as formulations containing solvents and wetting agents whose penetration behaviour differs from that of pure chemicals. Testing uses application-realistic formulations rather than single substances.