Introduction to standards

Hi, I am George. And I am a producer of hand disinfectants. A hand disinfectant is a product, normally containing ethanol and gel, to be applied in the hands to eliminate COVID-19, or other viruses or bacteria, from the hands of the users of the product. My first question is, what do I need to do to make sure that my product is safe, and has the necessary quality as required in the market?

Hi, I am Sophie, and I think I can help you with this. The first think you need to know is, if there is any requirement in the market for such a product, that you need to comply with. Such requirement, could be a compromise between the offer from the manufacturers and the expectation from the consumers or the users of the product. It could also be a mandatory requirement, established in a text of a legislation.

Well, regarding expectations from the user of my hand disinfectant, it is clear that they may expect that the product is effective in eliminating viruses.

I understand. Let me chech. Yes! I've got it!

What did you find, Sophie?

I have found that there is a European Standard covering requirements and test methods for chemical disinfectants and antiseptics, covering their virucidal activity. So I think this is what you are looking for.

A European standard? What is that?

Its a document containing requirements, test methods, amongst other important aspects, for their application in Europe. It is approved after reaching consensus amongst interested parties. Standards cover a wide range of products, services, processes or management systems. In this case, I see that the standard that I have found provides requirements and tests methods to check disinfectants that are used in the medical area in the fields of hygienic handrub and handwash, as well as product disinfection. Is that what you are looking for? Just in case, let me tell you that, in addition, there are other standards, for instance, covering bactericidal activity and other applicable aspects.

Indeed! Such a document containing requirements will give me valuable information on which are the requirements in Europe for hand disinfectants. But, why should I apply this European standard, when I have my own protocols to specify the product characteristics and tests?

Well, there are several reasons, why your product should comply with a European standard, or with an international standard, if they exist. The first reason is that, Standards are recognised references in the market. And your customers and users can easily check and understand which are the product characteristics and benefits your product brings.

Ok! What you say, makes sense. I guess that standards represent the consensus on a particular market. And if my product complies which such a standard, then my product is better accepted by the customers.

Another good reason is that, when a standard exists, many accredited laboratories start offering testing services, to check your product. This is interesting for your company, as you do not have to invest in equipment or training personnel to test your product. Not to forget that such tests are performed by competent personnel, in a credible, repeatible and impartial way, so the results can be accepted by users and authorities, responsible for market surveillance.

So the market surveillance, and other market enforcement authorities, can also use the standards to check my product? Please explain to me why this can happen?

Yes, this is often the case. More than six thousand European and international standards are cited in legislation in Europe. And often complying with such a standard, your product can be found to presumibly conform with the applicable requirements in the EU legislation. In the case of hand disinfectants, I see that the European standard that I mentioned to you is strongly recommended for assessing the efficacity of the product by the European Chemicals Agency and applied by market surveillance authorities to check this kind of products. In addition, I have checked that this standard is also often required in public procurement files of hospitals, contracts for cleaning services, and public authorities when purchasing hand disinfectants. So you should apply the European standard that I mentioned before.

Dear Sophie, this is really helpful. But, can I ask you? Why do you know so much about standards, conformity assessment and legislation in Europe?

I learned all of this when I successfully passed an intensive course on Standards, legislation, trade and enforcement at the European Business School of Standards. Why you just don't do the same if you are interested in the topic?

I will consider that, for sure. But I have a better idea! Why you don't advise my company as a consultant? We need someone like you, to help us complying with market requirements, including the regulatory ones.

That is a tempting offer! Why not? I am really looking forward to working with standards. So, I think we have a deal!