Known as EN549, standard UNE-EN 549:1996 regulates rubber materials for seals and diaphragms designed for gaseous fuel devices and equipment, according to the Spanish Association for Standardisation and Certification (AENOR). According to the International Classification of Standards (ICS), the following materials, when in compliance with this standard, pose no risk when in contact with gas:
- O-Rings (21.140)
- Rubber (83.060)
- Seals (83.140.50)
- Gas supply systems (91.140.40)
European standard UNE-EN 682:2002 (AENOR) defines the requirements for seals used in pipes and accessories for the transportation of hydrocarbon gases and fluids.
- Gaseous fuel (manufactured, natural and liquefied petroleum gas (LPG) in the gaseous phase).
- Hydrocarbon fluids with an aromatic content of up to 30% (V/V), including LPG in the liquid phase.
- Materials suitable for transporting gaseous fuels containing gas condensates and hydrocarbon fluids with an unlimited aromatic content.
This European Standard applies to all seal used in piping materials, including iron, steel, copper and plastics. In the case of composite seals, the requirements of items 4.2.8 and 4.2.9 only apply when the materials used for elastomeric parts come into contact with gaseous fuel or hydrocarbon fluid.
The elongation at break, tensile strength, compression set and stress relaxation requirements for materials of hardness categories 80 and 90 only apply when they are part of a seal that is directly involved in the sealing function or in long-term stability.
This standard is not applicable to the following:
- Seals made from cellular materials.
- Seals with enclosed voids as part of their design.
- Seals with requirements of resistance to flame or to thermal stress.
- Seals which contain splices joining pre-vulcanised profile end.
ACS – “Attestation De Conformité Sanitaire” (Certification of Sanitary Compliance) is the approval of safety required for materials and products in contact with drinking water in France. Manufacturers are required to obtain ACS approval for their products, whereby all materials used in a product that comes into contact with water are reviewed.
Metallic materials are checked to ensure they meet purity requirements. Organic materials are checked against a positive list. Information on formulation and composition is collected from suppliers of material and checked against a positive list.
The tests required depend on this review. In the event migration tests are required, the following parameters should be also be analysed:
- Smell and taste.
- pH and conductivity.
- TOC and chlorine demand.
- Chlorinated and non-chlorinated solvents.
- GC-MS screening and evaluation of cytotoxicity against human cells.
3-A SSI is an independent, non-profit corporation dedicated to advancing the hygienic design of equipment for the food, beverage, and pharmaceutical industries.
Created by the US food and dairy industry, 3A Sanitary Standards Inc. defines the specifications and best practices for the design, manufacture, installation and use of sanitary equipment. As with the FDA, 3A standards are implemented on a global basis.
Our O-rings are manufactured in accordance with 3A 18-03 “3A Sanitary Standards” for Multi-Purpose Rubber Materials Used as Product Contact Surfaces in Dairy Product Equipment, and also meet the applicable requirements for cleaning and disinfection solutions.
All 3A Sanitary-approved PPE elastomers are FDA CFR21.177.2600-compliant, contain no animal derived ingredients (ADIs), resistant to sterilisation with steam, fat and water and milk, acid and alkaline cleaning solutions and chlorine disinfectant solutions.
Manufacturers/users of equipment can select the most appropriate elastomeric material in accordance with temperature, chemical and physical performance requirements. 3A 18-03-compliant PPE elastomers include:
Class I – Silicone, FKM and FFKM; Class II – NBR and EPDM; Class III – HNBR
AENOR European standard UNE-EN 681-1:1996 defines the material requirements for elastomers (ICS 83.060) and seals for pipes and flexible assembles (ICS 23.040.80) used in water and drainage applications.
More specifically, this standard specifies the requirements for materials used in vulcanised rubber seals for:
- Supply of cold drinking water (up to 45 °C).
- Supply of hot drinking and non-drinking water (up to 110 °C).
- Drainage, sewage and rainwater systems (continuous flow up to 45 °C and intermittent flow up to 95 °C).
The various designations of the seals in question are defined according to their type, application and requirements.
In accordance with the temporary regulation of the Elastomer Guideline on the research of rubber samples and in accordance with the German Federal Environment Agency Guideline on the hygienic evaluation of elastomers in contact with drinking water (UBA Elastomer Guideline), O-rings made of the material M 534 (KC 568/15) are suitable.
TZW: DVGW-Technologiezentrum Wasser, is the German Water Centre belonging to DVGW e.V., the German Gas and Water Association, and an independent, non-profit institution. The organization has more than 150 employees and they conduct research close to the application and provide scientific guidance. TZW works together with water companies, businesses, public authorities and universities.
The mission of UBA with regard to drinking water is the continuous updating and optimisation of the scientific bases and measures for the supply of safe drinking water. They also assess the potential risks associated with the extraction, purification and distribution of drinking water, and develop work aimed at preventing such risks and, if necessary, managing them.
KIWA, based in the Netherlands, issues certificates in accordance with the Kiwa Regulation for Product Certification, which provides a legitimate expectation that the seals supplied (vulcanised rubber products for hot and cold drinking water applications) by JIOrings comply with their regulations.
As specified in the product certificate we provide (marked with the Kiwa® brand) with the sale of this type of seal, you can rest sure that these seals comply with the Kiwa BRL-K17504 evaluation guide “Vulcanised rubber products for hot and cold water applications” at the time of delivery.
Our seals meet the requirements of standard BRL-K17504, which meets the requirements of EN681-1, “Elastomeric Seals – Material requirements for pipe seals used in water and drainage applications – Part 1: Vulcanised rubber”. Ozone resistance class in accordance with BRL-K17504:
- For products with a high risk of attack by ozone, for example, in the case of products supplied separately with insufficient packaging or in the case of connections with pre-installed rubber subject to tension.
- For products for which normal resistance to ozone is required.
- For rubber that is never (partially) exposed to the open air when subject to tension. These products should always be transported in sealed packages. Type of application field in accordance with BRL-K17504:
- Supply of water supply at temperatures up to 50 °C.
- Supply of hot water supply at intermittent temperatures up to 110°C, or supply of water up to 110 °C in usable piping systems.
- Hot water circulation systems in accordance with classification class 2 in ISO 10508.
US standard NSF/ANSI establishes the minimum health-related requirements for materials, components, products and systems that come into contact with drinking water, drinking water treatment chemicals or both.
Standard 61 NSF/ANSI includes criteria for testing and evaluating products to ensure there are no contaminants seeping into the water, thereby posing a health issue. These contaminants include those regulated by the United States Environmental Protection Agency (USEPA) and Health Canada, as well as any other unregulated compounds that may be of concern.
Seals used in the following applications must comply with 61 NSF/ANSI: Water supply: transfer and distribution in water systems, pressure boosting in residential buildings and hotels, packaged pressure boosting systems.
- Water treatment: filtration, reverse osmosis and ultrafiltration systems.
- Processing plant water systems that require drinking water, such as breweries.
In our case, seals with this approval comply with the guidelines of the NSF/ANSI 61 establishing the health-relate criteria for many components of water systems, including:
- Protective barrier materials (cement, paint, coatings).
- Bonding and sealing materials (seals, adhesives, lubricants).
- Mechanical devices (water meters, valves, filters).
- Piping and related products (pipes, hoses, accessories).
- Plumbing devices (taps, drinking fountains).
- Processing means media (filtering means, ion exchange resins).
- Non-metallic drinking water materials.
WRAS - Water Regulations Advisory Scheme
The Water Regulations Advisory Scheme (WRAS) is a company that provides a series of services related to the safety of drinking water in the United Kingdom.
The WRAS certifies that the mixtures that comply with this approval are suitable for contact with domestic sanitary water that meets the requirements of BS 6920-1: 2000, which certifies the: "Suitability of non-metallic products for use in contact with water intended for human consumption with respect their effect on the quality of the water”.
This refers exclusively to their effect on the quality of any water with which they come into contact and does not imply the endorsement of their mechanical or physical properties for any use whatsoever.
Our mixtures are included in the list of materials that have passed the complete tests on the effect on the quality of water.
German DVGW (Deutscher Verein des Gas- und Wasserfaches) standard W534:2015-07 defines the standards to be met by pipe connectors and pipe joints in drinking water installations, specifically for metal (ICS 23.040.40) and plastic accessories (ICS 23.040.45).
Esta norma alemana W534:2015-07 de DVGW (Deutscher Verein des Gas- und Wasserfaches) define los estándares que deben cumplir los conectores de tuberías y empalmes de tuberías en instalaciones de agua potable, concretamente para accesorios de metal (ICS 23.040.40) y accesorios plásticos (ICS 23.040.45).
Based on the test results, the FDA certifies that the rubber compound awarded this approval (see table of approved mixtures) meets the requirements of FDA – CFR 21 – Parts 170 to 199 – Item 177.2600, paragraph (a), (b), (c) excluding contact with milk and edible oils, (d) use in contact with dry foods, (e) contact with aqueous foods and (f) contact with fatty foods.
The Food and Drug Administration (FDA or USFDA) is the United States government agency entrusted with the regulation of food, drugs, cosmetics, medical devices, biological products and blood by-products.
O-rings containing the EPDM70 Black Peroxide mixture are FDA-compliant pursuant to their "Federal Regulations – Title 21 - Food and Drugs” code.
The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. Title 21 of the CFR is reserved for the regulations of the Food and Drug Administration. Each title (or volume) of the CFR is revised once a year and is issued on or around 01 April of each year and is available online: Title 21 → Chapter I → Subchapter B → Part 170.
Our Nortap® silicone stoppers are also FDA-compliant.
European Regulation 1935/2004 of 27 October 2004 establishes the legislative community framework applicable to materials and objects designed to come into contact with food. It revokes Directives 80/590/CEE and 89/109/CEE, in force until this Regulation entered into force on 03 December 2004.
Compounds that meet all the requirements of the BfR (XXI Cat. 4) also meet the requirements of CE 1935/2004.
The German Federal Institute for Risk Assessment (BfR) and its predecessors have been issuing recommendations on the health assessment of materials in contact with food since 1958.
The inclusion of new substances and the alignment with current regulations require the recommendations to be adjusted on a regular basis. The objective of the German Federal Institute for Risk Assessment is to identify the risks arising from materials in contact with food and to protect the health of consumers in general.
BfR publishes updated recommendations in the “BfR Recommendations” database for food contact materials.
Our Nortap® silicone stoppers also meet all the requirements of the BfR.
USP CLASS VI
The USP (United States Pharmacopeia, is a non-governmental organisation that supports public health by establishing updated standards to safeguard the quality of medicines and other technologies related to medical care.
The USP establishes standards for quality, purity, strength and consistency published in the US Pharmacopeia. USP Class IV type products undergo a series of biological tests and must be composed of ingredients with a clear history of biocompatibility in compliance with strict leachate requirements.
USP-approved mixtures do not release leachable substances in cytotoxic concentrations. As such, we can ensure they meet USP CLASS VI requirements, in addition to the ISO test for the evaluation of in vitro cytotoxicity:
- “Biological in vitro reactivity tests – Elution test”, ISO 10993-1:2009
- “Assessment and testing within a risk management process”, ISO 10993-5:2009
- “In vitro cytotoxicity tests” and ISO 10993-12:2007
This study therefore illustrates the biocompatibility of our mixtures with USP CLASS VI.
Standard UL 778 regulates the standard use of motor-operated water pumps. These requirements cover submersible and non-submersible motor-driven pumps intended for use in normal facilities in accordance with the National Electrical Code, NFPA 70.
Moreover, the O-rings made from our mixtures (M534) are totally suitable for use in this type of pump.