EFHSS Questions and Answers - Question Q00228

Dear:
I want to know if use Formaldehyde sterilizer, how much is the drain value (or Formaldehyde concentration) in EN standard? such as 0.01% ??

where I could get it for reference.

Hardaway Liu
Getinge International AB (Beijing office)

Dear,

The prEN 14180: "Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers -Requirements and testing" is submitted now to the formal vote. In the draft text is no talk of a formaldehyde drain value.

Clause 4.2.3. Evacuation system says in 4.2.3.1., Note: Vacuum systems mostly operate by means of water. Attention should be paid to optimise the use of water in such systems, as there could be a balance between the use of resources and diluting of formaldehyde into concentrations harmless to environment (See also Annex F).

Annex F Environmental aspects says in F.3 Environmental impact:
"Formaldehyde solutions are known to be toxic, irritating and allergenic. They are also suspected to have carcenogenic effect on humans at long term exposure. The low level of airborn concentration needed to detect formaldehyde at inhalation normally limits the possibility of unconscious exposure to harmful concentrations.
EXAMPLES

• 0,05 ppm can normally be smelled;
• 0,01 ppm to 1,2 ppm may irritate the eyes;
• 0,5 ppm is in some countries regarded as a full-day working limit;
• 0,05 ppm to 1,2 ppm may irritate your nose;
• 1,0 ppm is in some countries regarded as a maximum level for 15 min;
• 4,0 ppm normally brings tears into the eyes.

National regulations may specify limits for the exposure of humans to airborn formaldehyde concentrations."

I hope this is helpful.
Kind regards,
Wim Renders