Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates

BS EN 15986:2011 Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates

BS EN 15986 is the British Standard that specifies the requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by Annex I of Directive 93/42/EEC Section 7.5, 2nd paragraph. This specifically includes the format of a symbol to be used in the labelling.

BS EN 15986 has been prepared to give expression to the legislative preference within the European Union for the use of symbols to provide information for the safe use of medical devices, and to the legislative requirement for labelling to show the presence of certain phthalates in medical devices.

It contains requirements for the labelling of medical devices or parts of medical devices containing phthalates requiring labelling, as required by the consolidated Medical Devices Directive 93/42/EEC, as amended by Directive 2007/47/EC.

Labelling of medical devices or parts of medical devices containing particular phthalates is required because some have been classified as CMR 1 & 2, i.e. they could exhibit carcinogenic, mutagenic or reprotoxic/developmental effects. Not all the reproductive and developmental toxicity of phthalates to the human body have been confirmed. However, it has recently been suggested that precautions be taken to limit the exposure of humans particularly that of high risk patient groups.

Phthalates have been extensively used as plasticizers due to the increased flexibility they impart to polyvinyl chloride (PVC), a plastic polymer used in a wide array of products including medical devices.

From a user's point of view a symbol conveys information in order that the user may assess the suitability of the medical device in order to mitigate risks to the patient. Due to the fact a number of phthalates with known and unknown biological effects exists on the market this European Standard includes only one symbol for medical devices “containing particular phthalates”.

The requirements in the consolidated Medical Devices Directive 93/42/EEC, as amended by Directive 2007/47/EC defines which medical devices containing phthalates have to be marked with the symbol. When the user has been informed that the product contains those particular phthalates precautionary actions can be found in the instruction for use.

BS EN15986 also provides information about the use of the general prohibition symbol.

Contents of BS EN 15986 include:

• Scope
• Terms and definitions
• Requirements for usage
• Symbol labelling phthalates
• Examples of uses of the symbol given in this European Standard
• Use of the negation symbol
• Relationship between this European Standard and the Essential
• Requirements of EU Directive 93/42/EEC
• Bibliography

Read more about EN 15986 on the European Committee for Standardization’s (CEN) website.