European Medical Glove Standard EN 455-3 updated

En 455-3 has been published. This is the first revision in 9 years, and replaces EN 455-3:2006.

The main change is related to the fact that the principle of reduction of risk to “as low as practically possible,” (ALARP)  is in conflict with the Medical Device Directive which does not allow economic considerations. Therefore the protein and chemical requirements have been re-written to refelect this.

Annex ZA has been rewritten, and reduces the number of Essential Requirements with which compliance can be presumed.  

Monograph 4.5 (leachable proteins) now requires that "The manufacturer shall strive to minimize the leachable protein level." (replacing the previous requirement of 'The leachable protein level shall be "As Low As Reasonably Practicable" (ALARP).')

SMTL are UKAS accredited to test against the requirements of monographs 4.3 (endotoxins), 4.4 (powder), 4.5 (leachable proteins) of the new standard.



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