1110 GLOVES: Reminder on standards Hand protection - what solutions? An ALL-IN-ONE glove is a need expressed by anyone working in a laboratory: "I need a glove that is comfortable, protects against all types of aggression and at low cost”. At Dulis, we believe that the use of several gloves is unavoidable in order to deal with the various risks and to guarantee the well-being and safety of users (while preserving laboratory budgets!) by relying on a simple technical point: the thicker and longer the glove, the better protected you are! ISO 374-5:2016: Biological risk assessment Determination of resistance to micro-organisms (AQL) and viral penetration ››› Standards and Regulations - How to find your way around? • Obligations of the employer: The 89/656/EEC Directive sets out the employer's obligations to protect his staff. Identification of risks and protective solutions to be implemented through the Single Document. • Obligations of the manufacturer (CE label): Depending on the activity and end use of the gloves, there are several options for manufacturers: - 93/42/EEC Directive: Medical Devices (MD) / intended for the protection of the patient. These gloves are usually called examination gloves. This is a self-certification by the manufacturer. - EU 2016/425 Regulation: Personal Protective Equipment (PPE) Designed to protect personnel against chemical and biological risks. Since April 2018 this regulation replaces Directive 89/686/EEC. There are 3 categories of PPE - PPE Category I - Minor Risk - Simple CE marking, must be used for low risk handling. This is a self-certification by the manufacturer. - PPE Category II - Intermediate Risk - PPE Category III - Risk of death or irreversible effects - Specific CE marking Specific CE marking. Protection against chemical and biological risks. The manufacturer must be audited by a Notified Person (NP) identified by 4 digits: 0120 = SGS; 0493 = CENTEXBEL; 0134 = SATRA Medical Device (MD) Standards The eN-455 standard allows the performance of examination gloves to be measured and compared between them: EN 455-1:2001: Statistical leakage test - AQL 1.5 (Acceptable Quality Level) EN 455-2:2015: Definition of physical characteristics such as length and height - The minimum length of an examination glove is 24 cm regardless of size - Sizes are expressed in letters from XS to XL EN 455-3:2015: Biological assessment (measurement of protein levels in latex gloves) The following standards are applicable to single-use gloves: Personal Protective Equipment (PPE) Standards The EN 420:2003+A1:2009 standard defines the general requirements for protective gloves. - The minimum length of a glove varies according to size, from 22cm (T6) to 27cm (T11) - Sizes are expressed in numbers from 6 to 11 - If a glove is shorter than the standard, it must be explicitly stated on the packaging as "suitable for special applications" The ISO 374 standard defines a methodology for measuring protection against chemical and biological hazards. LATEX NITRILE FORCES Elasticity Biological Barrier Comfort Chemical Barrier Biological barrier Price stability Natural product Comfort (less hot) Price WEAKNESSES Allergies type I and IV Allergies Type IV Chemical Barrier Elasticity Price instability Synthetic product Fragility Price ISO 374-5: 2016 (replaces the former EN 374-2:2003) The EN 374-2:2014 standard remains to demonstrate the effectiveness of the bacteria and fungi resistance. Water or air tightness test (AQL level). There are three levels of performance: Level 1: AQL 4.0 Level 2: AQL 1.5 Level 3: AQL 0.65 (best guarantee of tightness). The ISO 16604:2004 procedure B standard, determining the penetration resistance by blood-borne pathogens (PhiX 174), is incorporated into the biohazard assessment; gloves meeting the standard are labelled "virus" under the biohazard pictogram. Choice of materials some general guidelines Regulation, legislative framework ››› Standards set a consensus for measuring product performance
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