The 19th Meeting of ISO/TC 157 on Mechanical Contraceptives in Kuala Lumpur

by Nageswary S. Iyampillai
Standards Management Department
SIRIM Berhad

The 19th ISO/TC 157 Meeting on Mechanical Contraceptives was held at the Regent Hotel Kuala Lumpur from 8 - 12 July 2002.  Department of Standards Malaysia on behalf of the government hosted the meeting, with SIRIM Berhad providing the secretariatship for the meeting.  Dr. Hashim Hassan, Deputy Secretary-General (Policy) MOSTE on behalf of the Minister of Science, Technology and the Environment delivered the opening address.

About 112 delegates from 22 countries attended the meeting.  Three liaison organisations; WHO, DFID and Consumers International were also present at the meeting.  Aside from that new members countries such as Australia and Norway upgraded their status to participating member of the TC.

Ten local manufacturers such as Medical Latex (Dua) Sdn Bhd., Takaso Rubber Products Sdn Bhd, Hanarum Rubber Tech Sdn Bhd., Pleasure Latex Products Sdn Bhd., Richter Rubber Technology Sdn Bhd., Innolatex Sdn Bhd., SSN Medical Products, Revertex (Malaysia) Sdn Bhd., Sagami Industries (M) Sdn Bhd., and Karex Industries Sdn Bhd, partially sponsored the 19th ISO/TC 157 meeting.

The Malaysian delegation was led by Dato’ Dr Ong Eng Long from MREPC.  The other nine members were Dr Ismail Thambi, Mr Ng Kok Poon, and Ms Nageswary S. Iyampillai from the government departments while Mr C F Roberts, Mr Tharampal Singh, Dato’ T Usihama, Ms Catherine Lim Kwee Hua, Mr Goh Siang, and Mr Clinton Ang Teck Leong were from the manufacturing sectors. Thirty Malaysian observers from relevant government institutions such as the Ministry of Health, National Pharmaceutical Control Bureau, Malaysian Rubber Board, and suppliers of latex and local manufacturers were invited as guests to the meeting.

The 5-day meeting started with the synthetic condoms working group (WG) meeting. The WG reported that there were insufficient published data for the different characteristic of synthetic materials.  As such the WG agreed to make the necessary changes to the document to harmonise it with ISO 4074 and CEN documents.

On the second day, WG 15 on Additional Lubricants met where it was reported that the test results obtained were unpredictable and more tests needed to be carried out.

WG 13 on Oven Conditioning concluded that the real time accelerated data be made available at the next ISO/TC 157 meeting, while WG 10 on Bursting Properties decided that the technical corrections related to the document be forwarded to the ad hoc editorial group for their onward actions.  It was also agreed by WG 10 that non-technical corrections be considered during the next revision of the document.

Two ad hoc groups on extra strength and thickness respectively meet at this meeting. The ad hoc group on thickness reviewed comments on N583 document and agreed to align the procurement process with that of the World Health Organisation (WHO) procurement process.  The group also agreed to include two methods, i.e. digital gauges and weights method, where the reference method would be the weight method.  As for ad hoc group on extra strength, the members decided to source for more data on the requirement for double blind testing method for consideration at the next TC meeting.

A new work item on female condoms was presented for the members’ consideration.  It was generally agreed that requirements for synthetic condoms would be incorporated in the development of female condoms.  Members also discussed that there is a possibility for a new work item proposal for clinical trials on barrier contraceptives to be proposed at the next plenary meeting.

As for the new work item on copper-bearing intra-uterine contraceptive devices, it was unanimously agreed to be forwarded as a Draft International Standard (DIS).
There was also a motion to revise the newly published ISO 4074.  However, the TC agreed to defer the decision to the next plenary meeting.  In the meantime, the TC agreed to monitor the outcome of the current standard, to identify new or improving issues, to review old proposals from the experts supported by new rationales and to report to the TC if areas requiring revision to the standard is identified.

Members were notified of the 3-year transition period, which was requested for the manufacturers to familiarize themselves with ISO 4074, following which the EN 600 document would be withdrawn.

Lastly, the meeting was made aware of the publication of ISO 4074: 2002 Natural latex rubber condoms - Requirements and test methods, and ISO 16037 : 2002 Rubber condoms for clinical trials - Measurement of physical properties, which were published in May 2002.

As for the bidding of ISO/TC 157 Secretariat, four countries i.e. United States, India, South Africa and Malaysia forwarded their individual proposals to Technical Management Board (TMB).  TMB at their recent meeting in September 2002 unanimously agreed to reallocate the Secretariat to Malaysia.  Department of Standards Malaysia (DSM) as the national standards body of Malaysia was honoured with the entrustment of the responsibilities to take on the ISO/TC 157 Secretariat.