- Abstract: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 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 500000.
- Document number:DIN EN 455-2
- Issuing date:2015-07-01
- Document type:Norm
- Title:Medical gloves for single use - Part 2: Requirements and testing for physical properties; German version EN 455-2:2015
- Replaces:DIN EN 455-2(2011-05); DIN EN 455-2(2013-06)
- Author:DIN Standards Committee Health Technologies
- Search term:Compactness; Definitions; Density; Dimensions; Disposable; Disposable gloves; Disposables; Equipment for single use; Examination gloves; Gloves; Latices; Leak tests; Marking; Medical; Medical devices; Medical equipment; Medical products; Medical sciences; Occupational safety; Physical; Physical properties; Polyvinyl chloride; Properties; Protective clothing; Protective gloves; Protective measures; PVC; Specification (approval); Surgical gloves; Tear strength; Tear-out forces; Tensile strength; Testing; Throw-away clothes; Tightness
- Application areas:09.10 Medizinische Produkte; 30.35 Hand- und Armschutz
- Hazards:AB Terminologische Festlegungen in Normen mit Arbeitsschutzbezug; AC Mess- und Prüfverfahren für die Ermittlung von Belastungen und Gefährdungen; KE Belastungen durch Funktionsstörungen an Arbeitsmitteln (Ausfall, Bruch, fehlerhafte Montage, Softwarefehler, Störung der Energieversorgung)
- ICS:11.140 Hospital equipment
- Price:74,00 EUR
- Cross references:EN 455-4 (2009-07)<S>; EN 1041+A1 (2013-09){historisch}<S>; EN ISO 15223-1 (2012-07){historisch}<S>; ISO 188 (2007-06){historisch}<S>; ISO 23529 (2010-10){historisch}<S>; DIN ISO 23529 (2020-10); EUV 2017/745 (2017-04-05)
- Cited in:DIN 13155 (2016-03)<GLEITEND>; DIN 13155 (2018-11)<GLEITEND>; DIN 13157 (2021-11)<GLEITEND>; DIN 13164 (2022-02)<GLEITEND>; DIN 13169 (2021-11)<GLEITEND>; DIN 14142 (2018-03)<GLEITEND>; DIN 14142 (2018-09)<GLEITEND>; DIN 14530-8 (2010-08)<GLEITEND>; DIN 14800-13 (2020-11)<GLEITEND>; DGUV Grundsatz 304-001 (2016-09); DGUV Grundsatz 304-001 (2019-03); DGUV Grundsatz 304-001 (2022-04); DGUV Grundsatz 304-002 (2016-09); DGUV Grundsatz 304-002 (2020-03); DGUV Grundsatz 304-002 (2022-04); DGUV Information 207-007 (2022-03); TRBA 250 Änd 2018-05 (2018-05-02); TRBA 255 (2021-02-05)<STARR>; TRBA 260 (2017-12-14); GesundhHygieneHändeEmpf (2016-09)<STARR>; InfektionsprävKrankheitEmpf (2015-10)<STARR>
- Identical with:EN 455-2(2015-04)<IDT>
- Update flag:Unchanged