BS ISO 16038:2017 pdf download – Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
4.2 Clinical investigation Since condoms are medical devices, it may be appropriate to carry out clinical trials rather than relying on laboratory data when significant changes are made to the design, type of lubricant, etc., and or when new materials are used and new claims are made. Clinical trials may also be conducted to compare specific characteristics of different products. These characteristics can include donning, slippage and breakage studies, and other parameters that can affect the efficacy and safety of condoms. Clinical trials should be conducted under a written protocol to monitor the objectives clearly stated in accordance with ISO 14155 and ISO 29943-1. Due consideration should be given to the inclusion of appropriate reference condoms. The risk management should be carried out as specified in ISO 14971. ISO 16037 is a guidance document that recommends physical parameters that should be measured before conducting clinical trials. The clinical data thus generated should be reviewed as required to ensure continued safety and conformity to the performance requirements of the condoms. In the case of condoms made of synthetic materials, the values of physical properties measured form the basis for arriving at acceptance criteria for lot testing as part of quality verification as given in ISO 23409. Since the synthetic material can vary from design to design, the limits for arriving at acceptable minimum requirements of physical properties are derived based on the type testing results of the batches which are subjected to clinical investigation. The minimum requirements should be specified based on percentile values of individual condoms. Percentiles represent the value of parameters below which a certain percent of the observation falls.
4.3 Risk management
4.3.1 Risk analysis and risk management Manufacturers should carry out risk management as specified in ISO 14971 and make the risk management report available to institutional purchasers and regulatory agencies upon request within a framework of confidentiality. Any claims of additional features should have definite substantiated performance and safety data should be duly documented (e.g. for extra-strength condoms). As an important component of risk management, the manufacturer should inform the user, through labelling, of any properties of the product or substances contained within it that can cause irritation, sensitization or allergic reaction. Guidelines for labelling are specified in ISO 4074 and ISO 23409, as applicable. Attention should be given to the appropriate choice of colours and additives, which are approved by regulatory agencies or certified to be safe for use in human beings. The user should be advised of the potential for allergy in rare cases due to latex or other chemicals present in the formulation.
4.3.2 Latex allergy Condoms made from natural rubber latex or its blend release smaller amounts of protein than latex gloves as they have thinner films and shorter duration of usage. However, latex condom manufacturers should strive to keep the latex-protein level minimal. Control of extractable proteins is a quality management issue, and the manufacturer should be aware of and control the content and release of allergenic substances, such as extractable proteins, by appropriate process steps and controls; the process steps and controls should be part of the manufacturer’s quality management system. The methods for determining protein levels in latex products are given in ASTM D5712-99. These methods can be adapted to determine protein levels in condoms. Protein levels can also be determined by the ELISA method given in ASTM D6499-03.
4.3.3 Microbial contamination (bioburden) Although condoms are non-sterile medical devices, care should be taken during manufacturing operations to minimize microbiological contamination, particularly specific pathogens that affect the skin and mucosa. For example, various species of pseudomonas, staphylococcus and E. coli. The potential causes of contamination should be identified, controlled and monitored through the quality management system.BS ISO 16038 pdf download.