Medical gloves – Determination of removable surface powder (ISO 21171:2006)
Abstract
ISO 21171:2006 specifies methods for the determination of readily removable powder on the surface of gloves for medical use. Three methods are specified: method A for powdered gloves and methods B and C for powder-free gloves. This International Standard does not address safety issues that may be associated with the presence of powder on gloves nor does it prescribe limits on the amounts that may be present. The applicability of this International Standard to medical gloves not made from rubber has not been established.
DIN EN ISO 21171:2006-08 (E)
Medical gloves – Determination of removable surface powder (ISO 21171:2006)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….2
Endorsement notice ……………………………………………………………………………………………………………………….2
Introduction ……………………………………………………………………………………………………………………………………3
1 Scope ……………………………………………………………………………………………………………………………..3
2 Principle …………………………………………………………………………………………………………………………3
3 Terms and definitions ……………………………………………………………………………………………………..3
4 Apparatus ……………………………………………………………………………………………………………………….4
5 Reagents ………………………………………………………………………………………………………………………..4
6 Sampling ………………………………………………………………………………………………………………………..4
7 Method A — Procedure for powdered gloves ……………………………………………………………………4
8 Calculation of the result (method A) ………………………………………………………………………………..5
9 Methods B and C — Procedure for “powder-free” gloves ………………………………………………….5
10 Precision ………………………………………………………………………………………………………………………..8
11 Test report …………………………………………………………………………………………………………………….10
Bibliography …………………………………………………………………………………………………………………………………11
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC ……………………………………………………………………….12