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LIST OF STANDARDS

GCE always puts quality and reliability first in its manufacturing and design processes. By following (and in many cases exceeding) current European manufacturing standards it assists GCE to reduce risk, ensure consistency, and provides a reliable framework for all of its manufacturing and design activities.

The following list is a selection of the most common current quality standards in use today.

MEDICAL STANDARDS

 

93/94/EEC - Medical Device Directive

EN ISO 7396-1 - Medical gas pipeline system - Part 1: Pipeline systems for compressed medical gases and vacuum

EN ISO 8185 - Respiratory tract humidifiers for medical use -- Particular requirements for respiratory humidification systems

EN 1789 - Medical vehicles and their equipment. Road ambulances.

ISO 15002:2008 - Flow-metering devices for connection to terminal units of medical gas pipeline systems

Basic Standard: IEC / EN ISO 60601-1 - Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems

ISO 10524-1 - Pressure regulators for use with medical gases -- Part 1: Pressure regulators and pressure regulators with flow-metering devices.

EN ISO 9170-1:2008 - Terminal units for medical gas pipeline systems. Terminal units for use with compressed medical gases and vacuum

Basic Standard: IEC / EN 60601-1-2 - Collateral standard: Electromagnetic compatibility - Requirements and tests

EN ISO 10524-3 - Pressure regulators for use with medical gases -- Part 3: Pressure regulators integrated with cylinder valves.

EN ISO 10079-3 - Medical suction equipment. Suction equipment powered from a vacuum or pressure source.

EN 60 601-1-8 - Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.

ISO 10524-4:2008 - Pressure regulators for use with medical gases -- Part 4: Low-pressure regulators

BS 4272:1996 - Anaesthetic and analgesic machines. Specification for intermittent (demand) flow analgesic machines for use with 50/50% (V/V) nitrous oxide and oxygen.

EN ISO 5359 - Low-pressure hose assemblies for use with medical gases.

  

INDUSTRIAL STANDARDS

CUTTING & WELDING

EN 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)

EN 1256:2006 - Gas welding equipment. Specification for hose assemblies for equipment for welding, cutting and allied processes.

EN ISO 5171:2009 - Gas welding equipment -- Pressure gauges used in welding, cutting and allied processes.

ISO 3821:2008 - Gas welding equipment -- Rubber hoses for welding, cutting and allied processes

PROCESS APPLICATION

97/23/EC - The Pressure Equipment Directive

ISO 14114:1999 - Gas welding equipment -- Acetylene manifold systems for welding, cutting and allied processes -- General requirements.

ISO 7291:2010 - Gas welding equipment -- Pressure regulators for manifold systems used in welding, cutting and allied processes up to 300 bar.

DIN EN 730-1:2002 - Gas welding equipment. Safety devices Incorporating a flame (flashback) arrestor.

 

ISO 15615:2013 - Gas welding equipment -- Acetylene manifold systems for welding, cutting and allied processes -- Safety requirements in high-pressure devices.

ISO 9090:1989 - Gas tightness of equipment for gas welding and allied processes.

ISO 10297:2006 - Transportable gas cylinders -- Cylinder valves -- Specification and type testing.

ISO 5175:1987 - Equipment used in gas welding, cutting and allied processes -- Safety devices for fuel gases and oxygen or compressed air -- General specifications, requirements and tests

ISO 9539:2010 - Gas welding equipment -- Materials for equipment used in gas welding, cutting and allied processes

HIGH PURITY STANDARDS

The standards, directives and regulations for „HIGH PURITY“ regulators :

ISO 9001:2008 - Quality management systems – Requirements

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 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.

Directive 94/9/EC: Guidelines on the application (ATEX)

97/23/EC - The Pressure Equipment Directive.

CGA E-4-2010 - Standard for Gas Pressure Regulators.

 

DIN EN 13792 - Colour coding of taps and valves for use in laboratories; German version EN 13792:2002.

 

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.

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).

CGA G-4.1-2009 - Cleaning Equipment for Oxygen Service

 

FDA 21 CFR 820 - Quality System Regulations - Quality System Regulation QSR Requirements for Medical Device Manufacturers for FDA 21 CFR Part 820 Compliance.

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.

 
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