Condom Hazard Analysis and risk factors associated with failure

Hazard analysis is carried out on the basis on documented procedure TF/W203/MDD. The hazard level of finished product (condom) was valued by calculations and by expert method on the documentation analysis and proved by independent tests, including the certification tests.

Hazard Analysis covered the following risk groups:

Biological hazards;

Environmental impact hazards  (external factors);

Hazards associated with the use of condom (latex condom and polyurethane condom);

Hazards arising from violations of functioning, aging;

Manufacturing process -Manufacturing process hazards;

Conclusions of condom Hazard:

1. The condom product has no risks of I and II levels (undesirable and unacceptable).

2. After defining and reducing all possible risks the Hazard Analysis results for condoms are acknowledged as “Acceptable” with Level III.