Jämför kriterie 1, formuläret skickas in automatiskt när ett alternativ har valts Select Area för kriterie 1 Select Area Building and property Cleaning and chemicals Food IT and Telecom Labour law requirements Nursing and care Office and textiles Toxic-free preschool Vehicles and transport
Select Group för kriterie 1 Select Group Medicinal products Medical Consumables Health Care EEE Laundry and textile services Disposable textiles for use in health care Packaging within hospital care and health care sector
Select Sub Group för kriterie 1 Select Sub Group Disposable gloves for medical use General criteria Enteral nutrition Incontinence and urology products
Select Criteria för kriterie 1 Select Criteria Quality assurance procedures Standards for the manufacture and inspection of disposable gloves Pinhole defects (AQL) for disposable gloves Powder-free disposable gloves Substances for skincare in disposable gloves Limitation of biocides (antimicrobial substances) Limitation of phthalates (vinyl gloves) Accelerator-free disposable gloves (nitrile) Laboratory gloves with personal protection from chemicals Primary and secondary packaging for disposable gloves Sensitizing (allergenic) compounds in disposable gloves Content of Substances of Very High Concern (Candidate List) Climate impact of the product Requirements under the ILO core conventions Sustainable supply chains
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Criterion text
The following standards or the equivalent shall be met during the production of medical gloves for single use, examination gloves and surgical gloves:
EN 455-1:2020+A1:2022 Medical gloves for single use - part 1: Requirements and testing for freedom from holes
EN 455-2:2015 Medical gloves for single use - part 2: Requirements and tests for physical properties
EN 455-3:2015 Medical gloves for single use - part 3: Requirements and tests for biological evaluation
EN 455-4:2009 Medical gloves for single use - part 4: Requirements and testing for shelf life determination
Medical gloves for single use shall be labelled with symbols in accordance with EN ISO 15223-1: 2021, see the annex regarding marking and information that shall be provided together with medical gloves for single use.
Medical gloves for single use shall be tested in preclinical evaluation in accordance with:
EN ISO 10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity), and
EN ISO 10993-10:2023 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization).
The following harmonised standards shall be met during the manufacture of laboratory gloves (gloves for personal protection):
EN 21420:2020 Protective gloves — General requirements and test methods
EN 374-1:2016 Protective gloves against dangerous chemicals and micro-organisms - Part 1: Terminology and performance requirements for chemical risks (ISO 374-1:2016)
EN 374-2:2019 Protective gloves against dangerous chemicals and micro-organisms - Part 2: Determination of resistance to penetration
EN 16523-1:2015+A1 2018 Determination of material resistance to permeation by chemicals - Part 1: Permeation by potentially hazardous liquid chemicals under conditions of continuous contact.
EN 374-4:2019 Protective gloves against dangerous chemicals and micro-organisms - Part 4: Determination of resistance to degradation by chemicals.
EN 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks
Laboratory gloves shall be labelled in accordance with the requirements in EN 21420:2020 along with hazard symbols (pictograms), showing the protective function of the gloves for the specified risk. See the Marking of laboratory gloves with personal protection from chemicals annex.
