BS 6256:2021

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Packaging for terminally-sterilized medical devices. Method for determination of methylene blue particulate penetration

Published By	Publication Date	Number of Pages
BSI	2021	34

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Categories: 11.080.30 - Sterilized packaging, BSI

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Description

This British Standard describes methods of demonstrating the performance of the microbial barrier of porous material used in a sterile barrier system by penetration of particles of methylene blue.

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PDF Pages	PDF Title
4	Foreword
7	0 Introduction 1 Scope
8	2 Normative references 3 Terms and definitions 4 Principle
9	Figure 1 — Circuit diagram of apparatus for methylene blue particulate penetration test
10	Figure 2 — Test piece holder for methylene blue particulate penetration test 5 Apparatus, components and layout
11	6 Procedure 6.1 Preliminary 6.2 Start-up instructions 6.3 Preparation of standard stains
12	6.4 Preparation of test stains 7 Expression of results 8 Maintenance of apparatus
14	Annex A (normative) Specification of components of the apparatus
15	Figure A.1 — Illustration of assembly of apparatus (plan view)
16	Figure A.2 — Illustration of assembly of apparatus (side view)
18	Figure A.3 — Atomizer assembly Table A.1 — Components of atomizer
19	Figure A.4 — Atomizer head
20	Figure A.5 — Nozzle. Material: brass
21	Figure A.6 — Evaporation tube Table A.2 — Components of the control cock
22	Figure A.7 — Control cock
23	Figure A.8 — Control cock body
25	Figure A.9 — Handle
26	Figure A.10 — Assembly of test paper holder
27	Figure A.11 — Base plate
28	Figure A.12 — Handle
29	Figure A.13 — Assembly
30	Figure A.14 — Cap
31	Figure A.15 — Holder
33	Bibliography

Additional information

Status	Definitive
Pages	34
Publication Date	2021-01-25
ISBN	978 0 539 12512 2
Standard Number	BS 6256:2021
Title	Packaging for terminally-sterilized medical devices. Method for determination of methylene blue particulate penetration
Replaces	BS 6256:1989
Descriptors	Testing conditions, Medical equipment, Strength of materials, Steam, Sterile equipment, Packaging, Paper, Air permeability, Mass, Bags, Tensile strength, Fluorescence, Water-absorption tests, Penetration tests, Impurities, Sterilization (hygiene), Marking, Roughness (surface), Test equipment, pH, Water absorption, Drums (materials handling equipment), Performance, Stain tests, Containers
Publisher	BSI
Committee	CH/198
ICS Codes	11.080.30 - Sterilized packaging

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BS 6256:2021

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