BS EN 868-6:2017 pdf download

BS EN 868-6:2017 pdf download.Packaging for terminally sterilized medical devices Part 6: Paper for low temperature sterilization processes Requirements and test methods.
The EN ISO 11607 series consists of two parts under the general title “Packaging for terminally sterilized medical devices”. Part 1 of this series specifies general requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. Part 2 of this series specifies validation requirements for forming, sealing and assembly processes.
General requirements for all types of sterile barrier systems are provided by EN ISO 11607-1.
The EN 868 series can be used to demonstrate compliance with one or more of the requirements specified in EN ISO 11607-1.
CEN/TC 102/WG 4 also appreciates the initiatives of CEN with regard to the minimization of adverse environmental impacts by standards. It was agreed that this subject should be given priority during the next edition of the EN ISO 11607 series that is the basic reference for all parts of the EN 868 series.
ISO 6588-2:20 12, Paper, board and puips — Determination of pH of aqueous extracts — Part 2: Hot extraction
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and times
ISO 9197, Paper, board and pulps — Determination of water-soluble chlorides ISO 9198, Paper, board and pulp — Determination of water-soluble sulfates
3 Terms and definitions
For the purposes of BS EN 868-6, the terms and definitions given in EN ISO 11607-1:2009+A1:2014 apply.
The transport packaging shall be legibly and durably marked with the following information:
a) reference, stock or catalogue number;
b) quantity;
c) the name or trade name and address of the manufacturer;
d) date of manufacture in accordance with Iso 8601;
e) lot number1
f) nominal mass in grams per square metre;
g) nominal sheet size or nominal width of rolls in millimetres and length in metres;
h) the recommended storage conditions.
B.5 Test report
The report shall include the following information:
a) the mean penetration time in seconds for each side of the paper;
b) on request, the identification of the product under test, the identification of the test-house and the date;
c) the normative reference of the test method.BS-EN-868-6-2017

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