BS ISO 19351 pdf free download

BS ISO 19351-2019 pdf free download.Fallopian rings – Requirements and test methods.
4.3.2 Primary pouch
Each pouch/blister pack shall ensure:
a) adequate protection of the contents during normal handling, transit and storage for a period of 4 years;
b) maintenance of sterility of the contents under dry, clean and adequately ventilated storage conditions at a temperature(s) ranging from 0 °C to 50 °C; and
c) minimal risk for contamination of the contents during removal from the pouch/blister pack.
4.3.3 Instruction for use
Every dispenser box shall be provided with at least one instruction for use describing the method to be adopted for:
a) loading of rings on the ring applicator; and
b) storage and handling requirements in clean and dry place.
4.3.4 Package seal strength
Fallopian rings packs shall be tested for package seal integrity and seal strength in accordance with Annex j and peel force shall be 4,4 N to 19,0 N.
4.3.5 Package seal integrity
Fallopian rings packs shall be tested for package seal integrity and seal strength in accordance with Annex I and there shall be no evidence of leakage of the package.
4.3.6 Sterility
Fallopian rings supplied as sterile shall meet the requirements of sterility test as specified in the latest version of national/international pharmacopoeia.
The manufacturer shall establish procedures and systems to validate the type of sterilization used for the fallopian rings as sterility testing alone cannot be deemed as the criteria for confirming the sterility of the product. Validation of ethylene oxide sterilization process shall be done according to ISO 11135 and gamma sterilization shall be done according to ISO 11137-1 and ISO 11137-2.
4.4 Biological requirements
The biological safety of fallopian rings shall be evaluated in accordance with the principles given in ISO 10993-L according to which fallopian rings are classified as a permanent contact implant device, and the following tests shall be complied with:
a) cytotoxicity as per ISO 10993-5:
b) sensitization as per ISO 10993-10
c) irritation or intracutaneous reactivity as per ISO 10993-10
d) subchronic (Subacute) toxicity as per ISO 10993-11
e) genotoxicity as per ISO 10993-3
1) acute systemic toxicity as per ISO 10993-11:
g) implantation as per ISO 10993-6.
These tests shall be repeated only in the case of a significant change such as change in formulation or grade of silicone tubing material, change in sterilization method, change in manufacturing process, etc.
The results of the test shall be reviewed and interpreted by a qualified toxicologist.
4.5 Radio-opacity
Fallopian rings shall be radiopaque. This test shall be a type test used for the initial evaluation of the silicone elastomeric tubing material. ASTM F640 shall be referred for determining radio-opacity of the elastomeric material.
4.6 Clinical evaluation
4.6.1 General
Fallopian rings made of silicone-based elastomer have been used to effect female sterilization for nearly 50 years. They have been studied extensively, and clinical reports from the published literatureLBi show a long history of safety and effectiveness. Rings manufactured in accordance with the requirements of this document are expected to have comparable clinical performance. This means the manufacturers’ fallopian rings are similar to the fallopian rings used in the cited published clinical studies and comply with this document with respect to the following characteristics:
— peak load;
— elongation at peak load;
— strain capacity;
— loading force on ring applicator;
— elastic memory;
— repeat loading strength.
To establish conformance with this document for a new design of fallopian rings, the manufacturer shall demonstrate, using a one-sided test, that the upper limit of the 95 % confidence interval for a one-year pregnancy rate is s2.0 %. To establish this, the manufacturer shall sponsor a clinical study of its new design and demonstrate clinical safety and effectiveness. Completion of the one-year phase of the study is sufficient to begin marketing. However, the women in the study should be followed for an additional four years to record any additional pregnancies and serious adverse events.
4.6.2 New clinical study of manufacturer’s fallopian rings
A manufacturer may make significant changes to the fallopian ring with respect to design, materials or manufacturing procedures. In this case, the manufacturer shall sponsor a clinical study of its fallopian ring and demonstrate clinical safety and effectiveness. To this end, the sponsor shall conduct a single- arm clinical study, enrolling sexually-active women of reproductive age, following these women for a total of five years. Biostatistical analysis of the study shall show, using a one-sided test, that the upper limit on the 95 % confidence interval for the one-year failure rate (pregnancy) is less than 2,0 %. Completion of the one-year phase of the study is sufficient to begin marketing. However, the women in the study should he followed for an additional four years (a total of five years) to record any additional pregnancies and serious adverse events. Any unusual findings shall be included in updated labelling.
5 Storage condition
The fallopian rings shall be stored at a temperature ranging from 0 °C to 50 °C.BS ISO 19351 pdf download.