Key changes to standards for condoms – are you up to date?

5

Lot size limited to 500,000 - no effect on current scheme or products

6

Specific requirements for biocompatibility introduced - no effect on current scheme as products must be CE marked before being Kitemarked

7

Introduces recommendation for periodic monitoring of microbial contamination - added to quality plan requirements on protocol. This will be confirmed on CAV

8

Product claims - specific requirements for extra strength condoms deleted, but manufacturers must provide documentation to justify any additional claims

10

New minimum airburst volume for condoms 65 mm and over - customers with affected models will require additional test for transition. Customer’s lab test equipment will need to comply. This will be confirmed on CAV

Annex H

Radius of inner edge of clamping collar min 2 mm. Customers lab test equipment will need to comply. This will be confirmed on CAV

11.2

To replicate the use of the deleted clause 6.2, for bursting volume and pressure after heat ageing from the old standard, clause 11.2 will be included in type, batch, and audit tests using heat ageing to 168 ± 2 h at 70 ± 2 °C, followed by testing to clause 10.

12

Test method ASTM D3492 now included as option.  Customer’s lab test equipment using this test in production testing will need to comply. This will be confirmed on CAV

Annex M

Volumes of electrolyte used brought into line with water test. Customer’s lab test equipment using electrolyte test in production testing will need to comply. This will be confirmed on CAV

Annex M

Volumes of electrolyte or water used for leak testing specified in Table M.1.  Higher volume required for models ≥ 56 mm and longer condoms. Customers to declare length of certified models - customers with affected models will require additional test for transition. Customer’s lab test equipment will need to comply. This will be confirmed on CAV

Annex M

Measuring interval for voltage extended to measure from first immersion. Customer’s lab test equipment using electrolyte test in production testing will need to comply. This will be confirmed on CAV

Annex M

Limit of visibly open seals introduced in Table A.1 – New requirement will be included in audit and batch testing.

Annex P

Recommended requirements for sizes falling outside the limits of the standard introduced – If customers need to include outsize condoms please contact the Scheme Manager

11

Amendments made to the methods for determining shelf life of condoms - documentation for new condoms will have to comply. Limited requirements from Clause 11.2 included in type, audit and batch testing in protocol

11

Testing for freedom from holes, airburst properties and package integrity required in stability studies – documentation for new condoms will need to show compliance

Annex F

Additional method of determining thickness introduced, and density constant value reduced. Customer’s lab test equipment using this test in production testing will need to comply. This will be confirmed on CAV

Annex C

Additional method of determining total lubricant introduced. Customer’s lab test equipment using this test in production testing will need to comply. This will be confirmed on CAV

15.2.2

Revised requirements for labelling and information supplied with the condom – existing labelling will require updating. Key changes are:

• If symbols are used on the outside of the consumer packaging, their meaning should be explained in the additional information on the inside of the consumer package or a leaflet contained within the consumer package.

• Additional information

ü  the need to stop and check if the user feels the condom slipping off or tightening excessively onto the penis because this might lead to breakage

ü  advice to seek medical assistance as soon as possible, at least within 72 h should a condom leak or burst during use

ü  advice that if the individual container is obviously damaged to discard that condom and use a new one from an undamaged package

ü  A statement that the condom is for single use and that if reused there might be an increased risk of failure or infection

15.2.4.1

• Consumer package

ü  A full description of the condom, for example whether or not it has a reservoir tip, is parallel sided or shaped, is coloured or natural, textured or plain, has a flavour or fragrance, and is lubricated or not. A diagram may be used to convey some of this information.

ü  A statement to store the condom in a cool dry place away from direct sunlight. Accepted symbols may be used as an alternative

ü  A statement that the condom is made of natural rubber latex, which might cause allergic reactions including anaphylactic shock if the user is allergic to latex. An accepted symbol for natural rubber latex may be used as an alternative. If a symbol is used the additional information on the inside of the consumer package or a leaflet contained within the consumer packaging shall include a statement warning about the risk of allergic reactions including anaphylactic shock if the user is allergic to latex.

ü  A statement that the condom is for single use only. An accepted symbol may be used as an alternative.

ü  A statement to read the instructions for use. An accepted symbol may be used as an alternative

ü  For condoms intended for distribution within the European Union, the CE Mark.

15.2.4.2

• Additional information

ü  the need to stop and check if the user feels the condom slipping off or tightening excessively onto the penis because this might lead to breakage

ü  advice to seek medical assistance as soon as possible, at least within 72 h should a condom leak or burst during use

ü  advice that if the individual container is obviously damaged to discard that condom and use a new one from an undamaged package

ü  A statement that the condom is for single use and that if reused there might be an increased risk of failure or infection

ü  An explanation of any symbol used on the packaging

ü  A statement that the condom is made of natural rubber latex, which might cause allergic reactions including anaphylactic shock if a symbol for latex is used on the packaging

ü  The date of issue or the date of latest revision of the instructions for use.

ü  For condoms intended for distribution within the European Union, the CE Mark.

15.2.5

• Condoms not distributed in consumer packages

ü  For condoms that are distributed without a consumer package (e.g. in single foils or strips of foils), complete information should be made available in accordance with local regulations.

ü  NOTE 1 In the European Union the labelling must comply with the European Medical Device Directives 93/42/EEC as amended.

ü  NOTE 2 In countries outside of Europe, information can be in the form of leaflets, training sessions, posters, or additional packing added in the distribution chain, subject to local regulations. For guidance on the content, see 15.2.4.1 and 15.2.4.2.