Medsafe Modernizes Contraceptive Standards to Include ‘New’ Materials

New Zealand’s Medsafe is updating its standards for contraceptive devices supplied in the country to bring them in line with international standards and recognize contraceptives made from newer materials. The proposal would replace the current standard, BS 4028:1966, with ISO 8009:2004, which specifies minimum requirements and test methods to be used for reusable diaphragms made from natural rubber and silicone rubber. ISO 8009:2004 is not applicable to other vaginal contraceptive barriers, such as cervical caps, vaginal sponges and vaginal sheaths.
International Medical Device Regulatory Monitor