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BS 6256:2021

BS 6256:2021

$167.15

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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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.

PDF Catalog

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

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BS 6256:2021
$167.15