BS EN 455-3:2015
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Medical gloves for single use – Requirements and testing for biological evaluation
| Published By | Publication Date | Number of Pages |
| BSI | 2015 | 38 |
This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 5 | Foreword |
| 7 | Introduction |
| 8 | 1 Scope 2 Normative references 3 Terms and definitions |
| 9 | 4 Requirements 4.1 General 4.2 Chemicals |
| 10 | 4.3 Endotoxins 4.4 Powder-free gloves 4.5 Proteins, leachable 4.6 Labelling |
| 11 | 5 Test methods 5.1 Endotoxins 5.2 Powder 5.3 Proteins, leachable 6 Test report |
| 12 | Annex A (normative) Method for the determination of aqueous extractable proteins in natural rubber gloves using the modified Lowry assay A.1 Scope A.2 Principle A.3 Reagents A.3.1 General A.3.2 Extractant |
| 13 | A.3.3 Lowry protein assay reagents A.4 Apparatus |
| 14 | A.5 Measurement of protein binding capacity A.5.1 General A.5.2 Protein binding capacity of centrifuge tubes |
| 15 | A.5.3 Protein binding capacity of filter units A.6 Procedure A.6.1 General A.6.2 Extraction procedure |
| 16 | A.6.3 Protein standard A.6.3.1 Stock protein solution A.6.3.2 Protein standard solutions A.6.4 Precipitation and concentration of protein |
| 17 | A.6.5 Colour development A.6.6 Measurement A.6.6.1 Micro-plate reader A.6.6.2 Spectrophotometer A.7 Expression of results A.7.1 Calculation A.7.1.1 Calibration curve |
| 18 | A.7.1.2 Concentration of extract A.7.2 Results |
| 19 | Figure A.1 — Extraction of gloves (cross section) |
| 20 | Figure A.2 — typical standard curve measured in a spectrophotometer at 750 nm with 1 cm path length A.7.3 Statistical information |
| 21 | Table A.1 — Statistical information A.8 References |
| 22 | Annex B (informative) Immunological methods for the measurements of natural rubber latex allergens B.1 Introduction B.2 Natural rubber latex allergens in manufactured rubber products |
| 23 | B.3 Methods for measuring natural rubber latex allergens B.3.1 Qualitative methods B.3.2 Semiquantitative methods B.3.2.1 Skin prick testing in voluntary latex-allergic subjects B.3.2.2 IgE-ELISA inhibition (also known as RAST-Inhibition) B.3.3 Specific quantitative methods B.3.3.1 Capture enzyme immunoassays (EIA) for NRL allergen quantification B.3.3.2 Background |
| 24 | B.3.3.3 Description of capture EIA methods 3F ) B.3.3.4 Performance of the capture EIAs in comparison with IgE-based allergen assays |
| 25 | B.4 Conclusion B.5 References |
| 28 | Annex C (informative) Amino acid analysis (AAA) by high pressure liquid chromatography (HPLC) C.1 Background C.2 Principles of the determination of proteins by HPLC C.3 Material |
| 29 | C.4 Buffers and solutions C.4.1 Norvalin-100 C.4.2 Norvalin-1 C.4.3 o-Phthaldialdehyde (OPA) C.4.4 Boratebuffer C.4.5 Stop-solution |
| 30 | C.4.6 Phosphate buffer C.4.7 Solvent 1 C.4.8 Solvent 2 C.4.9 Sodium carbonate solution (0,1 M) C.5 Hydrolysis C.5.1 Samples C.5.2 Standards C.5.3 Incubation (hydrolysis) C.5.4 Free amino acids C.6 Analysis (HPLC) C.6.1 Sample preparation |
| 31 | C.6.2 Derivatisation C.6.3 HPLC C.6.4 Calculation C.7 Examples C.7.1 Standard C.7.2 Glove extract |
| 32 | C.8 Advantages and disadvantages of the HPLC method C.8.1 Advantages C.8.2 Disadvantages Table C.1 — List of amino acids found in the HPLC analysis of a standard solution (Figure C.1 a)) and in the hydrolysis of the glove extract (Figure C.1 b)) |
| 34 | Figure C.1 — typical chromatograms of an amino acid standard (A) and an analysis of a glove extract (35 µg protein) C.9 References |
| 36 | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Medical Devices Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC Medical Devices Table ZA.2 — Relevant Essential Requirements from Directive 89/686/EEC on Personal Protective Equipment that are addressed by this European Standard |
