The British Pharmacopoeia (BP) is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them.
Reference: The British Pharmacopoeia - British Pharmacopoeia
Indicates a warning notice in the text.
Reference: BS EN ISO 15223-1:2016 REF No: 5.2.4
Indicates comformity with the relevant director or regulation:
Reference: European MDD 93/42/EEC (14 June 1993) - Described in Article 17
European Medical Device Regulation 2017/745 - Described in Article 20
Indicates the date when the medical device was manufactured.
Reference: BS EN ISO 15223-1:2016 REF No: 5.2.6
Do not re-sterilise the medical device.
Reference: BS EN 1SO 15223-1:2016 REF No: 5.2.6
Indicates a medical device should not be used if packaging has been damaged or opened.
Reference: BS EN ISO 15223-1:2016 REF No: 5.3.8
Indicates product listing on Drug Tariff.
Indicates the authorised representative within the European Community.
Reference: BS EN ISO 151223-1:2016 REF No: 5.1.2
The European Pharmacopoeia (EP) is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them.
Reference: European Pharmacopoeia Online (edqm.eu)
Indicates the product expiry date.
Reference: BS EN ISO 15223-1:2016 REF No: 5.1.4
Indicates the range of humidity which the medical device can be safely exposed to.
Reference: BS EN ISO 151223-1:2016 REF No: 5.3.7
Consult the medical device's instructions for use.
Reference: BS EN ISO 15223-1:2016 REF No: 5.4.3
Store product in a dry environment.
Reference: BS EN ISO 15223-1:2016 REF No: 5.4.3
Manufactured with natural rubber latex.
Reference: BS EN ISO 151223-1:2016 REF No: 5.4.5
Indicates the manufacturer's batch number.
Reference: BS EN ISO 15223-1:2016 REF No: 5.1.5
Manufacturer - the person placing the device on the market.
Reference: BS EN ISO 15223-1:2016 REF No: 5.1.1
Indicates that the device is a medical device as defined in the MDR 2017/745.
Reference: MDR 2017/745
Product is supplied non-sterile.
Reference: BS EN ISO 15223-1:2016 REF No: 5.2.7
Indicates the manufacturer's
Reference: BS EN ISO 15223-1:2016 REF No: 5.1.1
The product is sold with sales ready packaging.
Caution - USA Federal Law restricts this device to sale by, or on the order of, physician.
Reference: 21 CFR 801.109
Product is for single-use only and must not be re-used or re-processed.
Reference: BS EN ISO 15223-1:2016 REF No: 5.4.2
Product is sterilised using Ethylene Oxide.
Reference: BS EN ISO 15223-1:2016 REF No: 5.2.3
Indicates a medical device that has been subjected to a sterilisation process.
Reference: BS EN ISO 15223-1:2016 REF No: 5.2.1
Product is sterilised by Gamma Radiation.
Reference: BS EN ISO 15223-1:2016 REF No: 5.2.4
New UK product marking that is required for medical devices being placed on the market in Great Britain.
Reference: UKCA marking and training - Gain market access in Great Britain | BSI (bsigroup.com)
Indicates the range of humidity which the medical device can be safely exposed to.
Reference: BS EN ISO 15223-1:2016 REF No: 5.3.7
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