HIGH PURITY STANDARDS
The standards, directives and regulations for „High Purity“ regulators :
- ISO 9001:2008 Quality management systems – Requirements
"ISO 9001:2008 specifies requirements for a quality management system where an organization
• needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
• aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to ISO 9001:2008 are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.
(source: https://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=46486)
- The Pressure Equipment Directive (97/23/EC)
The Pressure Equipment Directive (97/23/EC) was adopted by the European Parlament and the European Council in May 1997. It has initially come into force on 29 November 1999. From that date until 29 May 2002 manufacturers had a choice between applying the pressure equipment directive or continuing with the application of the existing national legislation. From 30 May 2002 the pressure equipment directive is obligatory throughout the EU.
The directive provides, together with the directives related to simple pressure vessels (2009/105/EC), transportable pressure equipment (99/36/EC) and Aerosol Dispensers (75/324/EEC), for an adequate legislative framework on European level for equipment subject to a pressure hazard.
The Directive concerns items such as vessels, pressurised storage containers, heat exchangers, steam generators, boilers, industrial piping, safety devices and pressure accessories. Such pressure equipment is widely used in the process industries (oil & gas, chemical, pharmaceutical, plastics and rubber and the food and beverage industry), high temperature process industry (glass, paper and board), energy production and in the supply of utilities, heating, air conditioning and gas storage and transportation.
Under the Community regime of the Directive, pressure equipment and assemblies above specified pressure and/or volume thresholds must:
• be safe;
• meet essential safety requirements covering design, manufacture and testing;
• satisfy appropriate conformity assessment procedures; and
• carry the CE marking and other information.
Pressure equipment and assemblies below the specified pressure / volume thresholds must:
• be safe;
• be designed and manufactured in accordance with the sound engineering practice of a Member State; and
• bear specified markings (but not the CE marking).
(source: https://ec.europa.eu/enterprise/sectors/pressure-and-gas/documents/ped/index_en.html)
- ISO 2503:2009
Gas welding equipment -- Pressure regulators and pressure regulators with flow-metering devices for gas cylinders used in welding, cutting and allied processes up to 300 bar (30 MPa)
ISO 2503:2009 specifies requirements for single or two-stage pressure regulators without flow-metering devices for connection to gas cylinders used for
• compressed gases up to 300 bar (30 MPa),
• dissolved acetylene,
• liquefied petroleum gases (LPG),
• methylacetylene propadiene mixtures (MPS), and
• carbon dioxide (CO2),
for use in welding, cutting and allied processes. It does not cover pressure regulators having a nominal outlet pressure p2 > 20 bar. ISO 2503:2009 also specifies requirements for single or two-stage pressure regulators with flow-metering devices for connection to gas cylinders used for
• compressed gases or mixtures up to 300 bar (30 MPa), and
• carbon dioxide (CO2),
for use in welding, cutting and allied processes. Typical processes using this equipment are: tungsten inert-gas arc welding (TIG), metal-arc inert-gas welding (MIG), metal-arc active-gas welding (MAG), plasma arc welding, tubular-cored-wiretubular-cored-wire welding and plasma cutting. Annex B gives examples of flow-control systems and their flow-measuring devices.
(source: https://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=40644)
- ISO 7291:2010
Gas welding equipment -- Pressure regulators for manifold systems used in welding, cutting and allied processes up to 30 MPa (300 bar) ISO 7291:2010specifies requirements and test methods for pressure regulators in manifold systems used in welding, cutting, and allied processes for: a) compressed gases up to 30 MPa (300 bar); b) dissolved acetylene; c) liquefied petroleum gases (LPG); d) methylacetylene propadiene mixtures (MPS); e) carbon dioxide (CO2).
It is not applicable to pressure regulators fitted directly to the gas cylinders, as defined in ISO 2503.
(source: https://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=44967)
- CGA E-4-2010 Standard for Gas Pressure Regulators
This standard specifies requirements for regulators used with compressed gases to reduce the supply pressure from a storage cylinder, pipeline, or other source to the use pressure.
(source: https://webstore.ansi.org/RecordDetail.aspx?sku=CGA+E-4-2010)
- CGA G-4.1-2009 Cleaning Equipment for Oxygen Service
The cleaning methods described in this publication are intended for cleaning equipment used in the production, storage, distribution, and use of liquid and gaseous oxygen. This publication does not replace or supersede any regulatory cleaning procedures or cleaning requirements specified by a national authority. Examples of such equipment (illustrative of the primary intent of this publication) are stationary storage tanks, cargo tankers, and tank cars; pressure vessels such as heat exchangers and rectification columns; and associated piping, valves, and instrumentation.
(source: https://webstore.ansi.org/RecordDetail.aspx?sku=CGA+G-4.1-2009)
- ISO 5171:2009
ISO 5171:2009 specifies requirements for Bourdon-tube pressure gauges normally used with compressed gas systems at pressures up to 30 MPa (300 bar) in welding, cutting and allied processes. It also covers use for dissolved acetylene and for liquefied gases under pressure. It does not cover gauges for acetylene in acetylene-manufacturing plants.
(source: https://www.iso.org/iso/catalogue_detail.htm?csnumber=44987)
- DIN EN 13792
Colour coding of taps and valves for use in laboratories; German version EN 13792:2002
(source: https://www.techstreet.com/products/1061197#jumps)
- FDA 21 CFR 820 - Quality System Regulations
Quality System Regulation QSR Requirements for Medical Device Manufacturers for FDA 21 CFR Part 820 Compliance FDA 21 CFR Part 820, also known as the Quality System Regulation QSR outlines Current Good Manufacturing Practice CGMP regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. These requirements are meant to ensure that medical devices are safe and effective. Medical device manufacturers undergo FDA inspections to ensure FDA 21 CFR Part 820 compliance.
(source: https://www.mastercontrol.com/21_cfr_regulations/21_cfr_part_820/)
- Directive 94/9/EC: Guidelines on the application (ATEX)
GUIDELINES ON THE APPLICATION OF DIRECTIVE 94/9/EC of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially Explosive Atmospheres - Fourth edition September 2012 - Update December 2013.
(source: https://ec.europa.eu/enterprise/sectors/mechanical/documents/guidance/atex/application/)
- Regulation (EC) No 1907/2006 - REACH
of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency The purpose of this regulation is to ensure a high level of protection of human health and the environment. It shall apply without prejudice to Community workplace and environmental legislation. There are exemptions on medical, veterinary, alimentary, cosmetic products, on polymers and some on-site isolated intermediates.
- Restriction of the use of certain hazardous substances (RoHS)
Directive 2011/65/EH of the European Parlament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment.
