Legislation and standards

Optional standards

Optional pharmaceutical and bioprocessing industry standards

Other pump related standards

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Pump standards			Return
CE mark 98/37/EC The pumps comply with the relevant essential health and safety requirements of the European Council Directive 98/37/EC on the approximation of the laws of the Member States relating to machinery, enacted in the United Kingdom by The Supply of Machinery (Safety) Regulations 1992 (SI.1992/3073), The Supply of Machinery (Safety) (Amendment) Regulations 1994 (SI.1994/2063) and The Supply of Machinery (Safety) (Amendment) Regulations 2005 (SI.2005/831). The pumps are designed and manufactured in accordance with the following transposed harmonised European standards: BS EN ISO 12100, Safety of Machinery - Basic concepts, general principles for design, Part 1: 2003, Basic terminology, methodology. (Including amendment 14974 January 2004) Part 2: 2003, Technical principles. (Including amendment 14975 January 2004). BS EN 294: 1992, Safety of Machinery - Safety distances to prevent danger zones being reached by the upper limbs. (Including amendment 7655 March 1993). BS EN 349: 1993, Safety of Machinery - Minimum gaps to avoid crushing of parts of the human body. BS EN 287-1:2004 Qualification test of welders - fusion welding - Part 1: steels. (Including amendment 15598 February 2005, 16295 July 2006 & 16831 January 2007) Qualified welders are used and they have been tested to this standard.

Optional standards			Return
ATEX	94/9/EC	Equipment and protective systems intended for use in potentially explosive atmospheres (Atmosphères Explosibles).
BS EN 13951	2003	Liquid pumps. Safety requirements. Agrifoodstuffs equipment. Design rules to ensure hygiene in use.
3-A		American sanitary standards
EHEDG		European Hygienic Equipment Design Group.
PED	97/23/EC	Pressure Equipment Directive 97/23/EC, in the UK - Pressure Equipment Regulations 1999

Optional pharmaceutical and bioprocessing industry standards			Return
FDA		Food and Drug Administration.
ASME BPE	2005	ASME Bioprocessing Equipment.
MHRA	2007	Medicines & Healthcare Products Regulatory Agency - Rules and Guidance for Pharmaceutical Manufacturers and Distributors. This is the seventh edition of the "orange guide" (named after it's orange cover).
EC	1998 (revised 2004 & 2005)	European Commission - The rules governing medicinal products in the European Union. Volume 4 Good manufacturing practices - medicinal products for human and veterinary use. This is based on directive: 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use, and 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products.
ICH Q7A	2000	International Conference on Harmonisation - ICH Q7A Good manufacturing practice for active pharmaceutical ingredients
BS EN 12462	1998	Biotechnology - Performance criteria for pumps. This standard is applicable to pumps used in biotechnological processes, in which the release of micro-organisms should be limited or prevented for reasons of safety (ie micro-organisms are hazardous or potentially hazardous). The pump shall be classified for leaktightness, cleanability and sterilizability.

Other pump related standards			Return
The list above is not exhaustive, and we can also comply with various other standards. Please just ask. There are also numerous other standards related to pumps, for example for the fittings, seals and motors; and numerous standards on testing of pumps, documentation and tolerances.