By Laura Moorman
When selling products into a foreign market, a manufacturer must be able to navigate that country’s regulatory requirements. Each country may have its own unique regulatory requirement for various product types, as is the case with Brazil, and POU or POE products. Brazil issued legislation that states any device intended to improve the quality of water for human consumption must be certified by a certification body accredited by Inmetro, the Brazilian certification accreditation organization similar to ANSI in the United States. Further, these products must bear the Inmetro Seal of Conformity.
Devices intended to improve the quality of water for human consumption are defined in the following categories: filtering units, reverse osmosis membranes, hollow fiber membranes, ultraviolet devices and ozone devices. All these types of products are required to obtain the certification and bear the Inmetro Seal of Conformity under the applicable ABNT NBR standards, which are ABNT NBR 14908 and ABNT NBR 15176. Pressurized POU/POE devices are tested and certified under Standard 14908, and non-plumbed, gravity fed devices are tested and certified under ABNT NBR 15176. The requirements and performance claims between Standards 14908 and 15176 are very similar.
To bear the Inmetro Seal of Conformity a manufacturer must go through a full certification program by an Inmetro accredited certification body. The certification includes an audit of the manufacturing facility, collection of systems for testing, product testing, product marking and literature review, as well as periodic product testing and surveillance audits. The product testing (on three complete systems) is based on mandatory and elective requirements outlined in the standard. Each standard has mandatory and elective testing. Testing is outlined based on the applicable standard in Table 1.
Structural Integrity testing is applicable only to pressurized device and consists of two tests: hydrostatic pressure and fatigue. The hydrostatic pressure test is performed to ensure the product is watertight. The testing requirements are divided between point of entry and point of use devices. Any point of use device must remain watertight when tested for 15 minutes at 1.5 times the maximum operating pressure as specified by the manufacturer. Any point-of-entry device with pressure vessels having a diameter up to eight inches (203.2 mm) must remain watertight when testing three times the manufacturers claimed operating pressure or 1,500 kPa, whichever is higher. POE devices with diameters greater than eight inches must remain watertight when tested 1.5 times the manufacturers operating pressure, or 750 kPa, whichever is higher.
The fatigue test is conducted to ensure a product is watertight through its life. As with the hydrostatic pressure test, testing is divided POU and POE devices. POU devices must be tested to 100,000 cycles (excluding those with upstream valves which are tested to 10,000 cycles) at 1.5 times the operating pressure.
Any POE device with pressure vessels having a diameter up to eight inches must remain watertight for 100,000 cycles when tested at the operating pressure specified by the manufacturer or 1,500 kPa, whichever is higher. POE devices with diameters greater than eight inches must remain watertight when tested to 100,000 cycles at the manufacturers operating pressure, or 750 kPa, whichever is higher.
Material safety testing is referred to as analysis for extractables and applies to all products certified under both 14908 and 15176. The purpose of this testing is to determine if a product leaches specific substances into the drinking water. The contaminants of concerns are defined by the standards and shown in Table 2. As long as the system does not leach the contaminants shown in Table 2, it is considered in conformance with the extractables requirement.
A microbiological control level test is conducted to determine if point-of-use products inhibit or limits bacterial growth. The products are seeded with Pseudomonas aeruginosa and operated. At end of life, the concentration of Pseudomonas may not be greater than initially upon seeding and at 95 percent of the manufacturers claimed service life.
In addition to the testing above, both standards require the product to be tested for at least one optional claim:
Particulate reduction requires the device to remove a minimum of 85 percent of the particles. The device is then classified according to Table 3, dependent upon its removal rate.
Chlorine reduction classifies the device according to the percentage of chlorine it reduces. The device is classified according to Table 4.
Bacteriological efficiency testing is performed using E. coli. The product must achieve a two-log reduction of E. coli at start up and at 95 percent of manufacturers claimed capacity.
If testing is successful, a product must bear the Inmetro Seal of Conformity (see Figure 1).
Finally, once certified, additional samples must be purchased from commerce and tested according to a specific schedule (see Table 5), with each period being nine months. After the fourth period, the cycle resets itself, so ongoing testing continues indefinitely.
About the author
Laura Moorman is the International Approvals Business Unit Manager for NSF International. Her business focus is tracking requirements and developing services to assist manufacturers with international approvals. For more information on achieving certification for the Inmetro Seal of Conformity, or on approval requirements for other countries, please contact Laura Moorman at NSF International at (800) NSF-MARK or [email protected]