YY/T 0698.5-2023Packaging materials for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods (English PDF)

4.2 Materials

4.2.1 Porous materials Porous materials shall comply with the requirements of YY/T 0698.2, 0698.3, 0698.6, 0698.7, 0698.9, or 0698.10. If the intended sterilization method is solely irradiation sterilization, the requirements for wet-state strength characteristics and air permeability of the porous material do not apply.

4.2.2 Plastic film

4.2.2.1 The plastic film shall be composed of two or more laminated layers. When tested after sterilization in accordance with Annex A, the interplybond shall not exhibit separation or whitening.

4.2.2.2 When tested in accordance with Annex B, the plastic film shall be free of pinholes.

4.2.2.3 When inspected under transmitted light (daylight or adequate artificial lighting) using normal or corrected vision, the plastic film shall be free from foreign matter and/or defects that would affect compliance with the requirements of 4.5. NOTE. Slight, continuous surface irregularities resulting from film extrusion shall not be considered defects.

4.2.2.4 The plastic film shall be capable of being heat-sealed to the porous material under the conditions specified by the manufacturer.

4.2.2.5 The breaking factor of the plastic film shall be no less than 20 N/15 mm. NOTE. The test method is specified in GB/T 1040.3.ASTM D882 may also be referenced for testing the tensile properties of plastic films.

4.3 Structure and design

4.3.1 The roll structure shall consist of a layer of porous material and a layer of plastic composite film, sealed together in parallel along their two edges. The structure of the combination pouch shall consist of a layer of porous material and a layer of plastic laminate film heat-sealed together along three of their edges. It may include an area for closing the combination pouch.

4.3.2 The total width of the seal shall be no less than 6 mm. For ribbed seals, the sum of the widths of the individual ribs shall be no less than 6 mm.

4.3.3 The distance from one end of the combination pouch to the nearest edge of the transverse seal line shall be sufficient to allow the two sides to be separated and peeled apart. NOTE. The side seal line may extend beyond the transverse seal line to the edge of the pouch. This does not affect its peelability.

4.3.4 One side of a combination bag shall be one of the following.

a) A thumb notch, not exceeding 12 mm in depth, shall be provided at the top, bottom, or both ends of the combination pouch. The base of the thumb notch shall be positioned at least 1 mm away from the seal line.

b) There is an offset edge; one face is at least

1.0 mm longer than the other. NOTE. The requirements of

4.3.4 do not apply to rolled materials sealed on three sides.

4.3.5 Pouches and/or reels shall be capable of being closed in accordance with the manufacturer's instructions. NOTE

1.The requirements for the validation of forming, sealing, and assembly processes are specified in GB/T 19633.2. NOTE

2.Closure and/or sealing systems can provide an indication of whether the seal has been opened.

4.4 Process indicators If a paper bag or tubular bag bears one or more Class 1 indicators, the performance of the indicators shall comply with the requirements of GB 18282.1.The area of each indicator shall be no less than 100 mm^2. The indicators shall not be affected by the sealing process.

4.5 Performance requirements and test methods

4.5.1 When tested in accordance with the methods specified in Annex C, the strength of the sealed joints, both before and after the sterilization process, shall meet or exceed the requirements necessary for the intended application. NOTE

1.The technical requirements for seal strength before and after sterilization may differ. not exceed 155 mm. For other information mentioned in

4.6 Marks...

4.6.1.1

a) and c), the repeat print interval shall not exceed 310 mm.

4.6.1.3 The labeling of pre-formed sterile barrier systems intended for sale to healthcare facilities shall not be confused with the labeling of the final product, such as the term "sterile".

4.6.2 Transport and/or storage packaging Each unit of transport and/or storage packaging shall be clearly and durably marked with the following information.

a) Product name or code;

c) Manufacturer's name and address;

d) Date of manufacture, in accordance with GB/T 7408;

e) Batch number 2;

f) Recommended storage conditions;

g) Compatible sterilization method(s).