BS EN ISO 4074:2015 Natural rubber latex male condoms. Requirements and test methods

BS EN ISO 4074:2015

Natural rubber latex male condoms. Requirements and test methods

Status : Current, Under review   Published : November 2015

Format
PDF

Format
HARDCOPY



What is this standard about?

It specifies requirements and test methods for male condoms made from natural rubber latex and supplied to consumers for contraceptive purposes and to assist in the prevention of sexually transmitted infections (STIs).

Who is this standard for?

  • Condom manufacturers
  • Regulatory agencies
  • Notified bodies
  • Condom purchasers

Why should you use this standard? 

To ensure that condoms are effective for contraceptive purposes and in helping prevent the transmission of STIs, they must fit the penis properly, be free from holes, have adequate physical strength so as not to break during use, be packaged to protect them during storage, and be correctly labelled to facilitate their use. This standard covers all these issues. In addition use of this standard provides one means of conforming to essential requirements in the New Approach Medical Devices Directive 93/42/EEC.

What’s changed since the last update?

This third edition cancels and replaces the second edition which has been technically revised. Modifications include the following:

  1. The maximum lot size has been limited to 500,000
  2. Specific requirements for biocompatibility assessments have been added
  3. It is recommended that manufacturers establish procedures for periodic monitoring of microbial contamination (bioburden) as part of their quality management system
  4. Specific requirements for extra strength condoms have been deleted and additional claims must be clinically substantiated
  5. A minimum airburst volume has been introduced for mid-body width condoms
  6. The radius of the inner edge of the clamping collar wherever it contacts the inflated condom has to be a minimum of 2 mm
  7. Several elements of the freedom from holes test have been modified 
  8. Amendments have been made to the methods for determining the shelf life of condoms
  9. The procedure for determining the thickness of a condom by the micrometer method is described in detail
  10. An alternative method of removing the lubricant from the condom using an aqueous surfactant solution has been introduction into the method for determining the amount of lubricant on the condom
  11. Revisions have been made to labelling requirements



Standard NumberBS EN ISO 4074:2015
TitleNatural rubber latex male condoms. Requirements and test methods
StatusCurrent, Under review
Publication Date30 November 2015
Normative References(Required to achieve compliance to this standard)ISO 2859-1:1999, ISO 10993-10, EN ISO/IEC 17025:2005, ISO 10993-5:2009, EN ISO 15223-1:2012, ISO 2859-1:1999/Corrigendum 1:2001, EN ISO 10993-1:2013, ISO 15223-2:2010, EN ISO 10993-1:2009, ISO 10993-1:2009, ISO/IEC 17025:2005, ISO 15223-1:2012, ISO 10993-1:2010, EN ISO 10993-5:2009
Informative References(Provided for Information)ISO 9000, ISO 16038, ISO/TR 8550, ISO 3534-2:2006, ASTM D3492, GUM 1995, ISO 13485, 93/42/EEC, EN 1041, ISO 11737-1:2006, ISO 14971, JCGM 100:2008, ISO 5893
ReplacesBS EN ISO 4074:2002
International RelationshipsEN ISO 4074:2015,ISO 4074:2015
Draft Superseded By09/30195720 DC12/30251858 DC18/30314313 DC
DescriptorsNatural rubber, Tensile strength, Tensile testing, Latices, Mechanical testing, Burst tests, Contraceptive sheaths, Contraceptives, Contraceptive devices
ICS11.200
Title in FrenchPréservatifs masculins en latex de caoutchouc naturel. Exigences et méthodes d'essai
Title in GermanKondome aus Naturkautschuklatex. Anforderungen und Prüfverfahren
CommitteeCH/157
ISBN978 0 580 88301 9
PublisherBSI
FormatA4
DeliveryYes
Pages72
File Size1.756 MB
Price£274.00


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