Published: 4 September 2013
4 September 2013
Contraceptive devices supplied in New Zealand, as required under section 6 of the Contraception, Sterilisation, and Abortion Act 1977, must comply with Standards as published in the Gazette by the Minister of Health. Medsafe is consulting about proposed changes to the Standards currently gazetted. Your input into this consultation is requested.
Only devices complying with the current gazetted Standards may be supplied in New Zealand.
The changes being consulted on are proposed for the following reasons;
to update older Standards to the latest versions to recognise international Standards for contraceptives for which there were no previous Standards, and to recognised international Standards for contraceptives manufactured from materials not covered by current Standards
The following Standards are currently gazetted.
|Standard Ref||Standard Name|
|ISO 4074:2002e Corrigenda 1: 2003||Natural Latex Rubber Condoms; Requirements and Test Methods|
|NZS 7106:1998||Polyurethane Condoms|
|NZS 7102:1980||Specifications for Intra-Uterine Contraceptive Devices|
|BS 4028:1966 with amendments||Specification for Reusable Contraceptive Diaphragm|
Information about the current gazetted Standards is published on the Medsafe website.
Medsafe is proposing to recommend to the Minister of Health that the following changes are made to the gazetted Standards.
It is proposed to REPLACE the following Standard:
|Standard to be replaced||New Standard|
|BS 4028:1966 with amendments||ISO 8009:2004 – Mechanical contraceptives – Reusable natural and silicone rubber contraceptive diaphragms, requirements and tests|
It is proposed to ADD the following Standards:
|ISO 23409:2011 – Male Condoms – Requirements and test methods for condoms made from synthetic materials|
|ISO 25841:2011 – Female Condoms – Requirements and test methods|
|ISO 7439:2011 – Copper-bearing contraceptive intrauterine devices – Requirements and tests|
Note that ISO 7439:2011 only applies to copper-bearing IUDs. This would be in addition to NZS 7102:1980 which would remain applicable to both copper bearing and non-copper bearing IUDs.
Until these proposed Standards are gazetted only devices complying with the current Standards may be legally supplied.
Copies of the above Standards are available for purchase from Standards New Zealand via their website.
You are invited to submit feedback on this proposal by Friday 27 September 2013 , to;
Condom Standards Consultation
PO Box 5013
OR by email to
with "Contraceptive Standards Consultation" in the subject line.
Following this consultation a recommendation will be made to the Minister of Health. The outcome of this process will be published on the Medsafe website.
Should you have any questions about this matter please email email@example.com