Standards
Home Up Motor efficiencies ATEX BS EN 13951 3-A EHEDG PED FDA ASME BPE

Legislation and standards

MDM PUMPS LTD specialises in tailor-made hygienic pumps using components machined from solid stainless steel 316L bar to give smooth, crevice-free internals, fitted with FDA-approved seals and hygienic connections. 

The pumps are built to last, and are widely sought after by the food, brewery, soft drinks, dairy and pharmaceutical industries.

We can comply with the requirements of for example: FDA, ASME BPE-2007, 3-A, EHEDG, ATEX and BS EN 13951.

Pump standards

Optional standards

Optional pharmaceutical and bioprocessing industry standards

Other pump related standards
 

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FDA pumps
ASME BPE pumps
3-A pumps
EHEDG pumps
ATEX pumps
BS EN 13951 pumps 

Pump standards

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CE mark 2006/42/EC

The pumps comply with the relevant essential health and safety requirements of the EU Machinery Directive 2006/42/EC. 

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+A1:2009, Basic terminology, methodology. (Incl. amendment 14974 Jan 2004)

Part 2: 2003+A1:2009, Technical principles. (Incl. amendment 14975 Jan 2004).

BS EN ISO 13857: 2008, Safety of Machinery - Safety distances to prevent hazard zones being reached by upper and lower limbs.

BS EN 349: 1993+A1:2008, 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

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ATEX 94/9/EC

Equipment 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

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FDA   Food and Drug Administration.  
ASME BPE 2007 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 & 2008)

 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

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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.