BS EN 455-2:2015 – TC:2020 Edition
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Tracked Changes. Medical gloves for single use – Requirements and testing for physical properties
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 32 |
This European Standard specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. 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 European 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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 20 | Contents Page |
| 21 | Foreword |
| 22 | 1 Scope 2 Normative references 3 Terms and definitions |
| 23 | 4 Dimensions 4.1 General Figure 1 — Designation of length and width of gloves 4.2 Length 4.3 Width |
| 24 | Table 1 — Dimensions of surgical gloves Table 2 — Dimensions of examination/procedure gloves |
| 25 | 5 Strength 5.1 General 5.2 Force at break |
| 26 | Figure 2 — Cutter for dumb bell specimens |
| 27 | Table 3 — Median values of force at break 5.3 Force at break after challenge testing |
| 28 | 6 Test report 7 Labelling |
| 29 | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning medical devices Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC concerning medical devices Table ZA.2 — Relevant Essential Requirements from Directive 89/686/EEC on Personal Protective Equipment that are addressed by this European Standard (according to Article 1 (6) of amended Directive 93/42/EEC) |
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