Certificazioni Gruppo Tecnogomma


To answer to the demands of the clients with a sure and reliable product is one of our prerogatives. The production of Or-Ring and of particular second sketch, as well as of all you stamp him for their realization, you/he/she is entirely performed near our establishments so that to guarantee a continuous vigilance on the final quality.

The whole productive trial and the departments are managed and motivated by the system of quality; the whole group is certified according to the norm An ENs ISO 9001:2008. Besides Tecnogomma International S.p.to. it is certified ISO TS 16949:2009 for the sector auto and according to the norm An ENs ISO 1400:2004 for the normative environmental.

the system of quality is approved DVGW for the production of articles from destined to fittings to gas and it is guarded by DVGW for applications in fittings for drinkable water.

 


WRAS
WRAS (Water Regulations Advisory Scheme) is the British Body that carries out the approvals for the drinking water applications according to the Standard BS6920.
These regulations provide a list of substances for which only the compounds containing admitted ingredients can be subjected to the laboratory tests.
The certifications vary depending on:

1 Typology of the material to be tested (NBR, EPDM, VMQ…);
2 Operating temperature (23°C, 60°C, 85°C);

Our compound TIMO-70 is approved in the section Material Only 5365 and in the section Components 5360, at the maximum temperature of 85°C.
The tests carried out by the entrusted laboratories are:
1 Smell and taste of the water;
2 Microbiological test on the aquatic growth of microorganisms;
3 Heavy metals extraction;
4 High temperature test;
5 Cytotoxicological test on live animal cells.
This approval has a five-year expiry.

 
KTW
TZW (TechnologieZentrumWasser) is the German Body that carries out the approvals for the drinking water applications according to the Regulations KTW 1.3.13.
These regulations foresees a list of substances for which only the compounds containing admitted ingredients can be subjected to the laboratory tests.
The certifications are distinguished according to:
1 Contact surface of the article (A ,B, C, D1 and D2);
2 Operating temperature (23°C, 60°C, 85°C).

Our compound TIMO-70 used for the production of seals with a contact surface with a relatively low level of water is certified in the categories D1 and D2, at the maximum temperature of 85°C.
The tests carried out by the entrusted laboratories are:
1 Smell, taste and aspect of the water;
2 Supply of organic compounds estimated as carbon (TOC);
3 Consumption of chlorine diluted in water;
4 Search of released substances like formaldehyde, phenol, aromatic amines, PAK;
5 The extraction of heavy metals like zinc and lead;
6 High temperature test.
This approval has a five-year expiry.

DVGW-W270
The DVGW W270 worksheet is required in accompaniment with the approvals of the drinking water applications according to the regulations KTW 1.3.13 for Germany.
This approval foresees a list of substances (the same as that of the KTW approval) for which only the compounds containing admitted ingredients can be subjected to the laboratory tests.
The test according to the worksheet W270 is a pure test on the compound, therefore it has to be carried out on the material (test slabs) used for the production of the article. It consists in positioning the rubber material in a running water pipeline for a period of 3 months. The result is a volumetric analysis of the bacteriological growth, which is scraped off the walls of the slabs.
Also in this case the requirements vary depending on the identified categories of the contact surface of the article (A, B, C, D1 and D2), the same of the KTW approval.
This approval has a five-year expiry.

EN 681-1
This is a European Norm which specifies the physical-mechanical requirements of the materials used in the vulcanised rubber seals for:
1 Cold drinking water (up to 50°C) conveyance;
2 Hot drinking and non-drinking water (up to 110°C) conveyance;
3 Waste water, sewer water and rainwater conveyance systems.

This regulation distinguishes different sealing categories (WA, WB, WC, WD, WE, WF, WG) depending on the type, the application, and the requirements to be respected indicated in two different tables. The foreseen tests are: hardness, tensile strength, elongation, compression set, ageing resistance in air, relaxation test, change of volume in water, ozone resistance.
Our compound TIMO-70 is certified according to the Standard EN 681-1 type WA, WB, WC, WD, for use in contact with cold and hot drinking and non-drinking water up to a temperature of 110°C.
 
DVGW-W534
This is a provision which is issued by DVGW that applies in particular to the seals, which are intended to be used in the press fittings, and therefore in contact with hot drinking water.
The Norm (with regard to the organoleptic tests on the materials) and EN 681-1 (with regards to the physical-mechanical tests) and in addition it adds a compression set test in water 3000h / 110°C, with a value survey every 1000h. This test has the clear intention of evaluating the material behaviour over quite a significant period of time. The maximum compression set admitted value is 40%, but it is important that the performance decay every 1000h not be superior to 5%.
The approval DVGW-W534 provides a supervision agreement between our Company and DVGW, which every year charges their representatives of verifying our production process and collect the samples to testing, which are therefore controlled yearly.

NSF
NSF is the American Foundation, which carries out different types of certifications for the drinking water the foodstuff and others; every type of certificate is identified by a standard-
Standard 61 is the one that concerns the drinking water field.
The first step is the verification, by a toxicological laboratory, of the formulation of the material, and therefore foresees a list of substances for which only the compounds containing admitted ingredients can be subjected to the laboratory for testing.
The second step is a first visit by the NSF representatives to our premises, who verify the production methods and the quality procedures adopted by the company.
The third step consists in the extraction tests on the materials.
The certifications are distinguished according to:
1 The contact surface of the article (expressed in sq. In./L);
2 Operating temperature (up to a maximum of 82°C).

Our compound TIMO-70 is approved up to the maximum temperature of 82°C.
The tests carried out by the entrusted laboratories are the extraction and search of dangerous substances, which could be released in the water like:
1 Aromatic hydrocarbons;
2 Half-volatile components with a high molecular weight;
3 Volatile components with a high molecular weight.

This approval has a yearly expiry that foresees an audit by the NSF representatives of our quality system with respective collection of samples for the tests.
Standard 51 regards the foodstuffs applications.
In this case the certification procedure is the same as that for Standard 61, with the only difference that the positive list used is that of FDA.
Our compound TIMO-70 is certified for food up to the maximum temperature of 100°C.

KIWA

KIWA is the Dutch Body that deals with the certifications for the drinking water according to the Regulations BRL 2013.
This standard foresees a list of substances for which only the compounds containing admitted ingredients can be subjected to the laboratory tests.
The certifications vary depending on the working temperatures, which in this case are the same as of the standard EN 681-1.
Our compound TIMO-70 is approved for use in contact with hot drinking water up to a temperature of 110°C.
The tests carried out by the entrusted laboratories are the following:
1 Smell, taste and aspect of the water;
2 Microbiological test on the aquatic growth of microorganisms;
3 Physical-mechanical tests (almost the same of the Standard EN 681-1).

This approval has a yearly expiry that foresees an audit by the KIWA representatives of our quality system with respective collection of samples for the tests.

ACS
ACS (Attestation de Conformite Sanitaire) is issued by the laboratories entrusted of carrying out the certifications for the drinking water application according to the circulars issued by the French Health Department.
This certification regards two circulars:
1 DSG/VS4 n° 2000/232 dated 27/04/2000;
2 DSG/VS4 n° 99/217 dated 12/04/1999.

The first mention a positive list of substances that the materials have to respect.
The second, in addition to the previous, provides a long series of migration tests according to the Norm XP P 41-250.
For the production of rubber seals with a diameter inferior to 63 mm the conformity to DSG/VS4 n° 2000/232 dated 27/04/2000 is enough, while for seals with a diameter superior to 63 mm the conformity to both directives is required.
The certifications vary depending on:
1 The contact surface of the articles (expressed in cm²/L);
2 Operating temperature.

Our compound TIMO-70 is certified for the production of seals with a contact surface of 3 cm²/L, at the maximum temperature.
The migration tests carried out by the entrusted laboratories aim to identify the dangerous substances (nitrosammine...) that could affect the drinkableness of water.
This approval has a five-year expiry.

D.M. n° 174
The Ministerial Decree n° 174 dated 06/04/2007 establishes, according to the Italian law, the requirements of the materials intended to be used in contact with drinking water.
The D.M. n° 174 provides a positive list of substances that the materials have to respect.
As regards to our compound TIMO-70, we have obtained a conformity certificate according to the D.M. 06/04/04 n° 174 from the Italian laboratory CERISIE.
The tests, which are carried out by the entrusted laboratories, are:
1 Immersion in distilled water tests;
2 Global migration tests;
3 Peroxides migration tests;
Colour, smell and taste of the water
 
FDA
FDA (Food and Drug Administration) is the American Body, which carries out the certifications for the foodstuffs.
FDA deals with a wide range of products; each identified in a proper section of the Norm. For the rubber articles the reference section is Title 21 (from page 170 to 1999), Article 177.2600, paragraphs “e” and “f”.
Paragraph “e” regards the suitability for use in contact with watery food, and uses distilled water as stimulating agent at the reflux temperature. The extract is verified and measured quantitatively after the first 7 hours and after the next 2 hours.
Paragraph “f” regards the suitability for use in contact with fat food, and uses the n-hexane as stimulating agent at the reflux temperature. The extract is verified and measured quantitatively after the first 7 hours and after the next 2 hours.
The Standard FDA provides a positive list of substances that the materials have to respect as well.
We have obtained a conformity certificate according to the Standard FDA 177.2600-21 paragraph “e” and “f” from the Italian laboratory CERISIE, for our TIMO 70 compound.

ÖNORM B 5014-1
TGM (Technologisches Gewerbemuseum) is the Austrian Institute that carries out the certifications for the drink water application.
ing water field according to the Standard ÖNORM B 5014-1.
The certifications vary depending on the working temperature (cold and/or hot drinking water), and the tests carried out by the entrusted laboratories are:
1 Supply of organic compounds estimated as carbon (TOC);
2 Consumption of chlorine diluted in water;
3 Smell, taste and aspect of water;
4 High temperature tests.

Our compound TIMO-70 used for the production of seals with a contact surface with a relatively low level of water is certified for use in contact with cold and hot drinking water at the temperature of 60°C.
This approval has a three-year expiry

USP CLASS VI

The United States Pharmacopoeia (USP) is a private (non-governmental) organization, which promotes public health establishing the regulations in order to assure the quality of medicines and other technologies for the health care.
These regulations include biological reactivity tests on living animals for elastomers, plastics and other polymeric materials with direct and indirect contact.
Monograph 88 USP describes the plastic classification in six classes based on the results of a series of tests on living animals for which the extracts, the materials and the ways of administration are specified.
Class VI requires the strictest tests of the six classes. The material extracts are prepared in proper solutions, which are injected into mice and rabbits that are kept under observance for over 72 hours. These extract tests are called: organism injection test and intracutaneous test. The materials that pass these tests suit the USP Class V.
USP Class VI, as well as the USP Class V test, provides an insert test in which material stripes and a negative control are placed in rabbits for almost 120 hours. Haemorrhages, gangrene, discolourations and infections are macroscopically observed and the encapsulation degree is tracked and compared with the negative control in order to determine the exit of the test.
Our compound TIMO-70 has been tested at the independent American laboratory The Toxicology Group LCC.
 
3-A SANITARY STANDARS
The approval 3-A Sanitary Standards n° 18-03 defines the requirements of the materials, which are intended to be used in presence of milk and/or milk by-products.
This standard is divided in some classes, depending on which substance comes into contact with the rubber seals and it provides a positive list of substances that the materials have to respect as well.
We have obtained a conformity certificate according to 3-A Sanitary Standards n° 18-03 Class II from the Italian laboratory CERISIE for our TIMO 70 compound.
The tests that are carried out by the entrusted laboratories are:
1 Physical-mechanical tests;
2 Test of immersion in butter;
3 Test of immersion in distilled water;
4 Test of immersion in acid solution;
5 Test of immersion in alkaline solution;
6 Test of immersion in chlorinated sanitizing solution.