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.<\/p>\n
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| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | European foreword <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 4 Requirements 4.1 General 4.2 Chemicals <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 4.3 Endotoxins 4.4 Powder-free gloves 4.5 Proteins, leachable 4.6 Labelling <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | Figure 1 \u2014 Symbol “Contains or presence of Type IV allergen” (derived from ISO 7000 \u2013 2725) <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 5 Test methods 5.1 Endotoxins 5.2 Powder 5.3 Proteins, leachable <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 6 Test report <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | Annex A (normative) Method for the determination of aqueous extractable proteins in natural rubber gloves using the modified Lowry assay A.1 General A.2 Principle A.3 Reagents <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | A.4 Apparatus <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | A.5 Measurement of protein binding capacity A.5.1 General A.5.2 Protein binding capacity of centrifuge tubes <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | A.5.3 Protein binding capacity of filter units A.6 Procedure A.6.1 General <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | A.6.2 Extraction procedure A.6.3 Protein standard A.6.3.1 Stock protein solution <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | A.6.3.2 Protein standard solutions A.6.4 Precipitation and concentration of protein A.6.5 Colour development <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 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 A.7.1.2 Concentration of extract A.7.2 Results <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | Figure A.1 \u2014 Extraction of gloves (cross section) <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | Figure A.2 \u2014 Typical standard curve measured in a spectrophotometer at 750 nm with 1 cm path length A.7.3 Statistical information <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | Table A.1 \u2014 Statistical information A.8 References <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | Annex B (informative) Immunological methods for the measurements of natural rubber latex allergens B.1 General B.2 Natural rubber latex allergens in manufactured rubber products <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 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) <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | B.3.3 Specific quantitative methods B.3.3.1 Capture enzyme immunoassays (EIA) for NRL allergen quantification B.3.3.2 Background B.3.3.3 Description of capture EIA methods3F B.3.3.4 Performance of the capture EIAs in comparison with IgE-based allergen assays <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | B.4 Conclusion B.5 References <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | C.4.5 Stop-solution 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 <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | C.6.2 Derivatisation C.6.3 HPLC C.6.4 Calculation C.7 Examples C.7.1 Standard <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | C.7.2 Glove extract C.8 Advantages and disadvantages of the HPLC method C.8.1 Advantages C.8.2 Disadvantages <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | Table C.1 \u2014 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)) <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | Figure C.1 \u2014 Typical chromatograms of an amino acid standard (A) and an analysis of a glove extract (35 \u00b5g protein) C.9 References <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | Annex ZA (informative) Relationship between this European standard and General Safety and Performance Requirements of Regulation (EU) 2017\/745 aimed to be covered Table ZA.1 \u2014 Correspondence between this European standard and Annex I of Regulation (EU) 2017\/745 [OJ L 117] and to system or process requirements including those relating to quality management systems, risk management, post-market surveillance syste… <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Medical gloves for single use – Requirements and testing for biological evaluation<\/b><\/p>\n |