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Steripharm labelling is designed to meet all applicable international standards and regulations. Where possible, Steripharm adopted the use of symbols to communicate requirements, product characteristics and provide guidance on handling and storage to the user. A compiled listing of symbols that may appear on the product labelling and the meaning of the symbol is provided in this document.
AUTH REPR IN EU COMMUN.
Indicates the authorized representative in the European Community.
Reference: SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016) Ref no: 5.1.2
DATE OF MANUFACTURE
Indicates the date when the medical device was manufactured.
Reference: SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.1.3
USE-BY DATE
Indicates the date after which the medical device is not to be used.
Reference: SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.1.4
CE-MARK
Indicates manufacturer declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation.
European Medical Devices Directive 93/42/EEC of 14 June 1993 (as amended by Directive 2007/47/EC). As described in Article 17 of the Directive.
CE-MARK WITH SGS NOTIFIED BODY NUMBER
Indicates manufacturer declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation.
European Medical Devices Directive 93/42/EEC of 14 June 1993 (as amended by Directive 2007/47/EC) As described in Article 17 of the Directive.
BATCH CODE
Indicates the manufacturer’s batch code so that the batch or lot can be identified.
SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.1.5
CATALOGUE NUMBER
Indicates the manufacturer’s catalogue number so that the medical device can be identified.
SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016. Ref no: 5.1.6
MANUFACTURER
Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC
Reference: SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.1.1
STERILIZED USING ETHYLENE OXIDE
Indicates a medical device that has been sterilized using ethylene oxide.
SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.2.3
DO NOT USE IF PACKAGE IS DAMAGED
Indicates a medical device that should not be used if the package has been damaged or opened.
SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.2.8.
KEEP AWAY FROM SUNLIGHT
Indicates a medical device that needs protection from light sources.
SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.3.2
KEEP DRY
Indicates a medical device that needs to be protected from moisture.
SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.3.4
DO NOT RE-USE
Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref. no: 5.4.2
Following Warnings should be taken while using the products from Steripharm Ltd FZC
» All devices are for single use only.
» Do not reuse, reprocess or re-sterilize the medical device.
» Devices are supplied sterile. They are sterilized using EO gas.
» Do not use if the sterile barrier is damaged. A broken sterile barrier means that the pack is non sterile. Use of non-sterile products may cause infection to the patients.
» These products are not intended for permanent use. They are for transient use only.
» Count pack components according to the hospital’s policy and confirm the contents post-surgery to avoid any complications of material being left behind in the patients. All details of the contents and their quantity are provided on the device labels.
» Reuse, reprocessing or re-sterilization may compromise the structural integrity of the pack components and/or lead to device failure which, in turn, may result in patient injury, illness or death.
» Reuse, reprocessing or re-sterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury or serious illness of the patient.
» The medical device use should not be carried out by unauthorized and untrained person. The medical device should be used only by well-trained surgeons in support with trained technicians.
» Upon completion of procedure dispose of the medical device/pack and its components if any as per institutional and local regulatory guidelines for bio-hazardous medical waste.
» Steripharm does not provide any implant/in-dwell components with the packs.
» Be careful to avoid injury from sharp instrument points or moving instrument parts.