Published: 4 September 2013

Consultations

Standards for Contraceptive Devices supplied in New Zealand

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

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.

Link to current contraceptive Standards information

Proposal

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:

New Standard
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.

Link to Standards New Zealand website

Providing Feedback

You are invited to submit feedback on this proposal by Friday 27 September 2013 , to;

Condom Standards Consultation
Medsafe
PO Box 5013
Wellington 6145

OR by email to

devices@health.govt.nz
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 devices@health.govt.nz