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BS EN 455-3:2023 – TC

BS EN 455-3:2023 – TC

$233.60

Tracked Changes. Medical gloves for single use – Requirements and testing for biological evaluation

Published By Publication Date Number of Pages
BSI 2023 99
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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
52 undefined
59 European foreword
61 Introduction
62 1 Scope
2 Normative references
3 Terms and definitions
63 4 Requirements
4.1 General
4.2 Chemicals
64 4.3 Endotoxins
4.4 Powder-free gloves
4.5 Proteins, leachable
4.6 Labelling
65 Figure 1 ā€” Symbol “Contains or presence of Type IV allergen” (derived from ISO 7000 ā€“ 2725)
66 5 Test methods
5.1 Endotoxins
5.2 Powder
5.3 Proteins, leachable
67 6 Test report
68 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
69 A.4 Apparatus
70 A.5 Measurement of protein binding capacity
A.5.1 General
A.5.2 Protein binding capacity of centrifuge tubes
71 A.5.3 Protein binding capacity of filter units
A.6 Procedure
A.6.1 General
72 A.6.2 Extraction procedure
A.6.3 Protein standard
A.6.3.1 Stock protein solution
73 A.6.3.2 Protein standard solutions
A.6.4 Precipitation and concentration of protein
A.6.5 Colour development
74 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
75 Figure A.1 ā€” Extraction of gloves (cross section)
76 Figure A.2 ā€” Typical standard curve measured in a spectrophotometer at 750 nm with 1 cm path length
A.7.3 Statistical information
77 Table A.1 ā€” Statistical information
A.8 References
78 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
79 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)
80 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
81 B.4 Conclusion
B.5 References
84 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
85 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
86 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
87 C.6.2 Derivatisation
C.6.3 HPLC
C.6.4 Calculation
C.7 Examples
C.7.1 Standard
88 C.7.2 Glove extract
C.8 Advantages and disadvantages of the HPLC method
C.8.1 Advantages
C.8.2 Disadvantages
89 Table C.1 ā€” 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))
91 Figure C.1 ā€” Typical chromatograms of an amino acid standard (A) and an analysis of a glove extract (35 Āµg protein)
C.9 References
93 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 ā€” 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…
96 Bibliography

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BS EN 455-3:2023 - TC
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