British Pharmacopoeia

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

Caution

Indicates a warning notice in the text.

Reference: BS EN ISO 15223-1:2016 REF No: 5.2.4

CE Mark/CE Mark with Notified Body Number

Indicates comformity with the relevant director or regulation:

  • Medical Devices Director EC 93/42/EEC
  • Medical Device Regulation 2017/745

Reference: European MDD 93/42/EEC (14 June 1993) - Described in Article 17

European Medical Device Regulation 2017/745 - Described in Article 20

Date of Manufacture

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

Do not re-sterilise the medical device.

Reference: BS EN 1SO 15223-1:2016 REF No: 5.2.6

Do Not Use if Packaging is Damaged

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

Drug Tariff

Indicates product listing on Drug Tariff.

Authorised Representative in European Community

Indicates the authorised representative within the European Community.

Reference: BS EN ISO 151223-1:2016 REF No: 5.1.2

European Pharmacopoeia

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)

Use By Date

Indicates the product expiry date.

Reference: BS EN ISO 15223-1:2016 REF No: 5.1.4

Humidity Limitation

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

Instructions For Use

Consult the medical device's instructions for use.

Reference: BS EN ISO 15223-1:2016 REF No: 5.4.3

Keep Dry

Store product in a dry environment.

Reference: BS EN ISO 15223-1:2016 REF No: 5.4.3

Contains or Presence of Natural Rubber Latex

Manufactured with natural rubber latex.

Reference: BS EN ISO 151223-1:2016 REF No: 5.4.5

Batch Code

Indicates the manufacturer's batch number.

Reference: BS EN ISO 15223-1:2016 REF No: 5.1.5

Manufacturer

Manufacturer - the person placing the device on the market.

Reference: BS EN ISO 15223-1:2016 REF No: 5.1.1

Medical Device

Indicates that the device is a medical device as defined in the MDR 2017/745.

Reference: MDR 2017/745

Non-Sterile

Product is supplied non-sterile.

Reference: BS EN ISO 15223-1:2016 REF No: 5.2.7

Product Number

Indicates the manufacturer's

Reference: BS EN ISO 15223-1:2016 REF No: 5.1.1

Sales Ready Packaging

The product is sold with sales ready packaging.


Prescription Device

Caution - USA Federal Law restricts this device to sale by, or on the order of, physician.

Reference: 21 CFR 801.109

Do Not Re-Use

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

Sterilised by Ethylene Oxide

Product is sterilised using Ethylene Oxide.

Reference: BS EN ISO 15223-1:2016 REF No: 5.2.3

Sterile

Indicates a medical device that has been subjected to a sterilisation process.

Reference: BS EN ISO 15223-1:2016 REF No: 5.2.1

Sterilised by Gamma Radiation

Product is sterilised by Gamma Radiation.

Reference: BS EN ISO 15223-1:2016 REF No: 5.2.4

UKCA

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)

Upper & Lower Temperature Limits

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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