Medical gloves for single useRequirements and testing for physical properties
BS EN 455-2:2009 Medical gloves for single use. Requirements and testing for physical properties
BS EN 455-2 specifies the 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.
BS EN 455 Part 2 now includes an informative annex to explain the relationship between the standard and the Essential Requirements of EU Directive 93/42/EEC concerning medical devices.
BS EN 455-2 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.
EN 455 consists of the following parts, under the general title Medical gloves for single use:
Part 1: Requirements and testing for freedom from holes
Part 2: Requirements and testing for physical properties
Part 3: Requirements and testing for biological evaluation
Part 4: Requirements and testing for shelf life determination
Contents of BS EN 455-2 include:
- Normative references
- Terms and definitions
- Force at break
- Force at break after challenge testing
- Test Report
- Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning medical devices
BS EN 455-2:2009 replaces BS EN 455-2:2000 which has been withdrawn.
|Title||Medical gloves for single useRequirements and testing for physical properties|
|Publication Date||30 November 2009|
|Withdrawn Date||31 October 2011|
|Cross References||ISO 188, ISO 23529:2004, 89/686/EEC, 93/42/EEC|
|Replaces||BS EN 455-2:2000|
|International Relationships||EN 455-2:2009|
|Draft Superseded By||08/30176484 DC|
|Title in French||Gants médicaux non réutilisables. Propriétés physiques. Exigences et essais|
|Title in German||Medizinische Handschuhe zum einmaligen Gebrauch. Anforderungen und Prüfung der physikalischen Eigenschaften |
|ISBN||978 0 580 61712 6|
|File Size||957.2 KB|
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