BS EN 868-6:2017 pdf free 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 n’iedical 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.
BS EN 868-6 specifies test methods and values for paper used in the manufacture of preformed sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of
EN 868 specifies materials, test methods and values that are specific to the products covered by this
European Standard.
Paper specified in BS EN 868-6 Is intended for use in part or complete manufacture of pouches and form and fill packs and lidding material for trays.
NOTE 1 The paper specified in this part of the EN 868 series is suitable br the manufacture of sterile barrier systems to be used in ethylene oxide, irradiation or low temperature steam formaldehyde sterilization processes and to produce coated paper according to EN 868—7.
NOTE 2 Paper according to EN 868-3 can also be used for these sterilization processes. The materials specified in this part of EN 868 are intended for single use only.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies For undated references, the latest edition of the referenced document (including any amendments) applies.
EN 20187. Paper, board and puips – Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187)
EN ISO 535, Paper and board – Determination of water absorptiveness – Cobb method (ISO 535) EN ISO 536, Paper and board – Determination ofgrammage (ISO 536)
EN ISO 1924-2, Paper and board – Determination of tensile properties – Part 2: Constant rate of elongation
method (20 mm/mill) (ISO 1924-2)
EN ISO 1974, Paper- Determination of tearing resistance – Elmendorf method (ISO 1974)
EN ISO 2758, Paper – Determination of bursting strength (ISO 2758)
EN ISO 11607-l:2009+Al:2014. Packaging for terminally sterilized medical devices – Part 1:
Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-
I :2006+AMD1 :2014)
ISO 2470-2, Paper, board and puips — Measurement of diffuse blue reflectance factor — Part 2: Outdoor daylight conditions (D65 brightness)
ISO 3689. Paper and board — Determination of bursting strength after immersion in water ISO 3781, Paper and board — Determination of tensile strength after immersion in water
ISO 5636-3, Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2009+A1:2014
apply.
4 Requirements
4.1 General
For any material, preformed sterile barrier system or sterile barrier system, the requirements of EN ISO 11607-1 shall apply.
This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1.
As such, the particular requirements in 4.2 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.
NOTE 1 Compliance to EN 868-6 does not automatically mean compliance to EN ISO 11607-1.
A confirmation of compliance to EN 868-6 shall contain a statement whether EN ISO 11607-1 is covered.
NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements. including the determination of the acceptability of these materials during validation activities, can apply
4.2 Performance requirements and test methods
NOTE See Annex D for repeatability and reproducibility of the test methods: pore diameters, sulphate content, chloride content and water repellency. For information on statement of precision and/or bias, repeatability and reproducibility of other test methods, see EN ISO 11607-1 :2009+A1 :2014, Table 8.1.
4.2.1 When the paper is to be used to manufacture packaging intended to be irradiation sterilized only, it is not necessary for it to have wet strength properties or any permeability to air, so 4.2.11,
4.3 Marking
4.3.1 Transport packaging
The transport packaging shall he 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 number’;
1) 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.
4.3.2 Labelling of individual units
Individual units shall be legibly and durably marked with the information a), b). d), e) and name or trade name according to 4.3.1.
NOTF Examples for individual units are reels or stacks of sheet material.