As specified in iso11607-1-2006, medical packaging materials must meet the following requirements:
1 The material shall be free from leaching and odourless under prescribed conditions, and shall not have adverse effects on the performance and safety of medical devices in contact with it.
2 there should be no perforation, damage, tear, wrinkle or local uneven thickness defects affecting the function of the material.
3 The weight of the material (mass per unit area) shall be in accordance with the specified value.
4 The material shall have acceptable cleanliness, particle contamination and floc falling level.
5 Materials shall meet established minimum physical properties, such as tensile strength, thickness difference, tear, permeability, and rupture resistance.
6 Materials shall meet established minimum chemical properties, such as pH, chloride and sulfate content, to meet the requirements of medical devices, packaging systems or sterilization processes.
7 Under the conditions of use, the materials shall not release toxic substances that may cause health hazards, whether before, during or after sterilization.
General requirements for medical packaging materials
1 The package material should not be decolorized. The hot water extract prepared according to ISO 6588-2 was visually tested to confirm its compliance.
2 according to GB/T 451.2, the average quality of 1m2 of the package material adjusted by the state shall be within the range of the manufacturer’s nominal value ±5%.
3 according to GB/T 1545.2, medium heat extraction method is used to prepare water extraction solution. The pH value of the extraction solution of wrapping material should be no less than 5 and no more than 8
4 in accordance with ISO 9197, the chloride content (in chlorides) of the thermal extract prepared with ISO 6588-2:2005 7.2 (except for 2ml potassium chloride solution) shall not exceed 0.05%(500mg/kg).
5 in accordance with GB/T 2678.6, the content of sulfate (in terms of sodium sulfate) in the thermal extract prepared with ISO 6588-2:2005 7.2 (except for 2ml potassium chloride solution) shall not exceed 0.25% (2500mg/kg).
6 according to GB/ t7974-2002, the fluorescent brightness (whiteness, F) of the wrapping material should be no more than 1%. The UV source is irradiated at a distance of 25cm, and the number of fluorescent spots larger than 1mm on the axis of 0.01m should not exceed 5.
7 according to EN1149-1:2006 test, state regulation after sterilization package material surface resistance should be less than 1 x 1013 Ω.