With more and more Legionella and Pseudomonas tap and shower filters on the market, it is vital to understand the importance of using certified products when it comes to the Medical and Life Science industries. As a minimum in the United Kingdom, the legal requirement is to have WRAS approval and have a product that is registered as a CE medical device.
Below is the documentation explaining where the information comes from and the framework of each certification.
So, what is a WRAS approval?
Any water fitting, which when installed, will carry or receive water from the public mains water supply in the UK, must comply with the Water Supply (Water Fittings) Regulations or Scottish Byelaws. These require that a water fitting should not cause waste, misuse, undue consumption or contamination of the water supply and must be ‘of an appropriate quality and standard’.
For all buildings, it is stated in chapter 2.33 of the second part of the HSG 274 document: “Materials used in building water systems must be compatible with the physical and chemical characteristics of water supplied to the building to reduce corrosion or prevent excessive scale formation of system pipework and components. Domestic water systems must not use materials that support microbial growth, such as those containing natural rubber, hemp, linseed oil-based jointing compounds and fibre washers. Similarly, any synthetic materials used should not adversely affect water quality by supporting microbial growth. Water fittings and components should be used that comply with the Water Regulations Advisory Scheme (WRAS) approval scheme 27 which lists products that have been tested and comply with BS 6920.”
More specifically for hospitals, HTM04-01: Safe water in healthcare premises Part B: Operational management states in paragraph 0.24 accentuates the matter: “As well as complying with the recommendations outlined in this document, the design and installation of the hot and cold water services, new or extended, in any healthcare premises should also comply with:
- the Water Supply (Water Fittings) Regulations 1999;
- Defra’s guidance to the Water Supply (Water Fittings) Regulations;
- recommendations of the water suppliers in the Water Regulations Advisory Scheme’s (WRAS) ‘Water Regulations Guide’, and
- any other requirements of the local water undertaker. recommendations of the water suppliers in the Water Regulations Advisory Scheme’s (WRAS) Water regulations guide.”
What is CE MEDICAL?
Where WRAS applies to water filtered in UK buildings, when used in hospitals or medical environments, it is a requirement to use a product that is CE Medical approved.
The Council directive 93/42/EEC establishes the scope of a medical device:
‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease.
In the case of our Legionella and Bacteria control tap and shower filter range, the product falls under the prevention of diseases, as its purpose is to avoid bacteria contaminating patients whilst in medical care. For more information on how Fileder can help specify the correct certified products for your application then please free to give us a call on 01622 684999 or make an enquiry below and one of the Life Sciences team will be able to help you.