Overview

This standard has been prepared by Technical Committee CEN/TC 205 "Non-active medical devices", the secretariat of which is held by DIN (Germany). At DIN, the German Institute for Standardization e. V., the responsible Working Committee is NA 063-01-05 AA "Medizinische Einmalhandschuhe" ("Medical gloves for single use") at the Medical Standards Committee (NAMed). This standard specifies requirements and test methods for physical properties of single use medical gloves (namely, surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user. This standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000. This document contains Amendment A1 (modification of Table 3 "Median values of force at break"), accepted by CEN on 2011-01-03.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-04-09 AA - Medical gloves for single use  

Responsible european committee

CEN/TC 205/WG 3 - Medical gloves