ISO 16038:2017

ISO 16038:2017 pdf free.Male condoms一Guidance on the use of ISO 4074 and ISO 23409 in the
quality management of condoms.
A condom is a single-use medical device, the performance and safety of which depends upon the design and the manufacturing process. New designs of condoms can require clinical testing, several other tests and analysis on a limited basis for validation purposes, such as shelf-life determination (type testing) and risk assessment. These requirements are generally prescribed by licensing authorities and the data generated become part of the master file for the product. Guidelines are available in Iso 13485 and the GMP requirements. When new products are developed, their design should conform to the requirements of design control as laid down in ISO 13485 and applicable GMP requirements.The safety of the materials used should be reviewed and ensured in accordance with applicable requirements.
NOTE For example, Medical Device Directive 93/42/EEC.
Design control activities should be documented as partof the qualitymanagementsystem documentation, reviewed and updated, when regulatory agency and/or customer needs warrant changes.
Whenever significant changes are made to the formulation or process that can substantially affect the performance and/or safety of the condoms, these changes should be evaluated, validated and documented.
EXAMPLE Changes in types of formulation, changes in lubricant, changes in primary (individual) packaging material, changes in leaching process.
Significant change is described as any change carried out to the approved design or process with the scope to materials, including packaging, formulation, manufacturing process, facilities or equipment, which can impact on performance, intended use, shelf life or other safety aspects, and which cannot be clearly excluded by a risk analysis.
Process validations should be carried out in accordance with the requirements of ISO 9001 or ISO 13485.
The design of synthetic condoms and the materials used result from consideration of the variety of materials possible and the need to meet the requirements of efficacy, adequate barrier properties and mechanical strength. The efficacy is evaluated through surrogate virus tests using bacteriophage Phi-X174, followed by clinical trials using comparison against natural rubber latex condoms as reference. Guidance on conducting in vitro viral penetration tests is given in documents such as the USFDA Guidelines and published literature. The penetration of bacteriophage Phi-X174 in test condom design should be evaluated with reference to approved design and levels published in literature. The median level of penetration has been reported to be 7 X 10 (4) ml. Details of conducting viral penetration tests, including limit of detection of the method and statistical interpretation of results, are given in ISO 23409:2011, Annex G.
Design validation should be used as the basis for ensuring that design parameters, such as dimensions, formulation, safety of components and biocompatibility, stability and shelf-life claims, packaging and dressing materials, etc., are appropriate. The biocompatibility studies should be done as per the requirements of ISO 10993-1, Iso 10993-5, ISO 10993-10 and the reports should be evaluated by a qualified toxicologist. When appropriate or necessary, such as when there has been a significant change in the formulation, skin irritation studies and a safety evaluation should be performed and documented as part of design control activities.ISO 16038 pdf download.

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