BS EN 868-5:2018 Packaging for terminally sterilized medical devices Part 5: Sealable pouches and reels of porous materials and plastic film construction – Requirements and test methods
BS EN 868-5:2018 pdf free.Packaging for terminally sterilized medical devices Part 5: Sealable pouches and reels of porous materials and plastic film construction – Requirements and test methods.
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 4.5 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 868-5 does not automatically mean compliance to EN ISO 11607-1.
A confirmation of compliance to EN 868-5 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, indicators, packing lists, mats, instrument organizer sets, tray liners oran 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 Materials
4.2.1 Porous material
The porous material shall comply with the requirements of Clause 4 of either EN 868-2:2017, EN 868-3:2017, EN 868-6:2017, EN 868-7:2017, EN 868-9:2018 or EN 868-10:2018.
If the intended method of sterilization is irradiation only, the requirements for wet strength properties and permeability to air for porous materials are not applicable.
4.2.2 Plastic film
4.2.2.1 The plastic film shall be a composite of two or more layers. When tested after the intended sterilization process in accordance with Annex B the plastics interply bond shall not separate nor become cloudy.
4.2.2.2 The plastic film shall be free from pinholes when tested in accordance with Annex C.
4.2.2.3 When examined by unaided normal or corrected vision in transmitted light (daylight or good artificial light) the plastic film shall be free from foreign matter and/or other imperfections that would adversely affect compliance with the requirements of 4S.
NOTE Slight continuous surface irregularities arising from the extrusion of the plastic film is not regarded as a defect.
4.2.2.4 The plastic film shall be sealable to the porous material under the conditions specified.
4.3 Construction and design
4.3.1 Reel material shall be constructed from one web of porous material and one web of plastic film. sealed together along parallel sides.
Pouches shall be constructed from one web of porous material and one web of plastic film by sealing three sides and may include an area to effect closure of the pouch.
4.3.2 The overall width of the seal(s) shall be not less than 6 mm. For ribbed seals, the sum of the widths of the ribs shall be not less than 6 mm.
4.3.3 The distance between the end of a pouch and the nearest edge of the width wise seal shall be sufficient to enable the two webs to be separated and peeled apart.
NOTE The side seals can extend beyond the width wise seal to the end of the pouch provided that this does not impair peelahility.
4.3.4 One of the materials of a pouch shall be:
a) provided with a thumb notch not more than 12 mm deep at either the top or bottom of the pouch or at both ends; the bottom of the notch shall be at least 1 mm from the seal; or
b) lipped such that the length of one web is greater than the length of the other web by not less than 1,0 mm.
NOTE The requirements of 43A do not apply to a reel that is sealed at the third side.
4.3.5 The pouch and/or reel shall be closed according to the manufacturer’s instructions.
NOTE 1 For validation requirements for forming, sealing and assembly processes, see EN ISO 11607-2.
NOTE 2 The closure and or sealing system can give the possibility to indicate whether or not the seal has
been opened.
4.4 Process indicator
If one or more T’pe I indicator(s) [process indicator(s)j are printed on the pouches and reels, the indicator’s performance shall comply with the requirements of EN ISO 11140-1. Each individual indicator shall be not less than 100 mm2 in area. Indicators shall not be affected by the sealing procedure.
4.5 Performance requirements and test methods
4.5.1 When tested in accordance with the method described in AnncxD, the strength of the seal shall be not less than required for the intended purpose, both before and after being subjected to the sterilization process.
NOTE 1 The specification for seal strength before and after exposure to sterilization processes can dif1er
For use for sterilization in healthcare facilities, the minimum value for seal strength shall be 1,5 N per 15 mm for steam sterilization and 1,2 N per 15 mm for other sterilization processes.
NOTE 2 Requirements for seal strength set forth in this Standard are valid for pouches and reels delivered as prefornied sterile barrier systems to healthcare facilities and for healthcare facilities to create a sterile barrier system. For applications in industry, different values can be established based on the specific applications and on the validation requirements of EN ISO 11607.
NOTE 3 l-Iealthcare facilities are locations where patients are medically treated and/or medical devices are terminally sterilized (e.g. hospital, dentist office, practitioner).
4.5.2 The seal shall be continuous and cover the specified width. There shall be no disruption of the surface of the porous material adjacent to the seal area upon opening. Compliance shall be tested in accordance with AnnexE.
4.5.3 If applicable, for porous materials, the direction of the peel marked on the product shall correspond to that direction which ensures least fibre disturbance. Compliance shall be tested in accordance with Annex F.
4.6 Marking
4.6.1 Pouches and reels
4.6.1.1 Pouches and reel material shall be clearly marked with information required by EN ISO 11607-1. Additionally, the following information shall be provided unless agreed otherwise between the supplier and the customer:
a) the words Do not use if the sterile barrier system is damaged”, or symbol (see EN ISO 15223-1:2016, Table 1, symbol 5.2.8);
b) lot number1);
c) the manufacturers name or trade name;
d) process indicator(s), if applicable;
e) the direction of peel which will ensure the least fibre tear for reels;
f) nominal dimensions and/or identification code.
4.6.1.2 The product shall not be printed on any surface which is designed to come into direct contact with the items to be packaged.
4.6.1.3 For lot number, process indicator, peel direction, and nominal dimensions or identification code [see 4.6.1.1 b), d), e) and 1)], the print repeat interval on reel material shall be not greater than 155 mm. For other information mentioned in 4.6.1.1 a) and c), the print repeat interval shall be not greater than 310 mm.
4.6.1.4 Preformed sterile barrier systems placed on the market for delivery to healthcare facilities
shall not be supplied individually labelled with a CE logo and/or with the symbol sterile” NOTE 1 This is to avoid confusion in terms of legal responsibility with the CE mark for the final product. NOTE 2 For CE marking of transport and/or storage packaging, see 4j h).BS EN 868-5 pdf free download.BS EN 868-5:2018 Packaging for terminally sterilized medical devices Part 5: Sealable pouches and reels of porous materials and plastic film construction – Requirements and test methods