Home » Medical Standards

MEDICAL STANDARDS

93/94/EEC - Medical Device Directive

"Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of:
• diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a handicap.
• investigation, replacement or modification of the anatomy or of a physiological process.
• control of conception
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted by such means. The Directive gives additional definitions of relevant devices and terms. The following products are excluded from the scope of the Directive:
• In vitro diagnostic devices
• Active implantable devices covered by Directive 90/385/EEC
• Medicinal products covered by Directive 65/65/EEC
• Cosmetic products covered by Directive 76/768/EEC
• Personal protective equipment covered by Directive 89/686/EEC
• Tissues or cells of human origin
• Viable tissue or cells of animal origin.

The Directive sets out the classification criteria for Medical Devices and outlines the appropriate conformity assessment procedures for each class of device."

(source: http://www.ce-marking.org/directive-9342eec-medical-devices.html)

Basic Standard: IEC / EN 60601-1-2

Collateral standard: Electromagnetic compatibility - Requirements and tests

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

"Applies to the safety of medical electrical systems, as defined as follows: combination of items of equipment, at least one of which must be medical electrical equipment and inter-connected by functional connection or use of a multiple portable socket-outlet."

(source: https://www.techstreet.com/products/861228#jumps)

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 1789

Medical vehicles and their equipment. Road ambulances.

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.

EN ISO 10079-3

Medical suction equipment. Suction equipment powered from a vacuum or pressure source.

"This part of ISO 10079 specifies safety and performance requirements for medical suction equipment powered from a vacuum or pressure source (see Figure 1). In particular it applies to connections for pipelines and Venturi attachments. Suction equipment with components controlled by electrical means, e.g. electronic timing, may also need to comply with IEC 60601-1. This part of ISO 10079 does not apply to electrically powered suction equipment, whether mains electricity or battery-powered, which is dealt with in ISO 10079-1, nor to manually powered suction equipment which is dealt with in ISO 10079-2, nor to the following: central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and wall connectors; catheter tubes, drains, curettes and suction tips; syringes; dental suction equipment; waste gas scavenging systems;laboratory suction; autotransfusion systems; passive urinary drainage; closed systems for wound drainage; gravity gastric drainage; orally operated mucous extractors; suction equipment where the collection container is downstream of the vacuum pump; equipment marked as suction unit for permanent tracheostomy; ventouse (obstetric) equipment; neonatal mucous extractors; breast pumps; liposuction; uterine aspiration."

(source: https://www.techstreet.com/products/713931)

EN ISO 10524-3

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

"Applies to pressure regulators integrated with cylinder valves intended for the administration of medical gases in the treatment, management, diagnostic evaluation and care of patients for use with the following medical gases: oxygen; nitrous oxide; air for breathing; helium; carbon dioxide; xenon; specified mixtures of the gases listed above; air for driving surgical tools; nitrogen for driving surgical tools.
These pressure regulators integrated with cylinder valves are intended to be fitted to cylinders with nominal filling pressures up to 25 000 kPa at 15 °C and can be provided with devices that control and measure the flow of the medical gas delivered."

(source: https://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=35372)

EN ISO 5359

Low-pressure hose assemblies for use with medical gases.

"ISO 5359:2008 specifies requirements for low-pressure hose assemblies intended for use with the following medical gases: oxygen; nitrous oxide; medical air; helium; carbon dioxide; xenon; specified mixtures of the gases listed above; oxygen-enriched air; air for driving surgical tools; nitrogen for driving surgical tools; vacuum.
It is intended in particular to ensure gas-specificity and to prevent cross-connection between systems conveying different gases. These hoses assemblies are intended for use at maximum operating pressures less than 1 400 kPa.
ISO 5359:2008 specifies the allocation of non-interchangeable screw-threaded (NIST) connectors, diameter-index safety system (DISS) connectors and sleeve indexed system (SIS) connectors to medical gases and specifies the dimensions of non-interchangeable screw-threaded (NIST)"

(source: https://www.iso.org/iso/catalogue_detail.htm?csnumber=42763)

EN ISO 7396-1

Medical gas pipeline systéme - Part 1: Pipeline systems for compressed medical gases and vacuum

"ISO 7396-1:2007 specifies requirements for design, installation, function, performance, documentation, testing and commissioning of pipeline systems for compressed medical gases, gases for driving surgical tools and vacuum in healthcare facilities to ensure continuous delivery of the correct gas and the provision of vacuum from the pipeline system. It includes requirements for supply systems, pipeline distribution systems, control systems, monitoring and alarm systems and non-interchangeability between components of different gas systems.
ISO 7396-1:2007 is applicable to pipeline systems for the following medical gases: oxygen, nitrous oxide, medical air, carbon dioxide, oxygen/nitrous oxide mixtures; to pipeline systems for the following gases: oxygen-enriched air, air for driving surgical tools, nitrogen for driving surgical tools; and to pipeline systems for vacuum.
ISO 7396-1:2007 also applies to extensions of existing pipeline distribution systems, modifications of existing pipeline distribution systems and modifications or replacement of supply systems or sources of supply."

(source: https://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=40440)

EN ISO 8185

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

EN ISO 9170-1:2008

Terminal units for medical gas pipeline systemsTerminal units for use with compressed medical gases and vacuum

" ISO 9170-1:2008 specifies requirements for terminal units for supply and disposal of nitrogen or air for driving surgical tools and requirements for probes intended to be connected to the gas-specific connection point which is part of the terminal unit."

(source: https://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=42055)

ISO 10524-1

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

"ISO 10524-1:2006 is applicable to the types of pressure regulators listed and is intended for the administration of the following medical gases in the treatment, management, diagnostic evaluation and care of patients: oxygen; nitrous oxide; air for breathing; helium; carbon dioxide; xenon; mixtures of the gases listed above; air for driving surgical tools; nitrogen for driving surgical tools. These pressure regulators are intended to be fitted to cylinders with nominal filling pressures up to 25 000 kPa at 15 °C and can be provided with devices which control and measure the flow of the medical gas delivered. The types of pressure regulators covered by ISO 10524-1:2006 are as follows: pressure regulators intended to be connected to cylinders by the operator; pressure regulators with integral flow-metering devices intended to be connected to cylinders by the operator; pressure regulators that are an integral part of medical equipment (e.g. anaesthetic workstations, lung ventilators, resuscitators)."

(source: https://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=38491)

ISO 10524-4:2008

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

"Applies to the types of low-pressure regulators listed below and intended to be used with the following medical gases in the treatment, management, diagnostic evaluation and care of patients: oxygen; nitrous oxide; medical air; helium; carbon dioxide; xenon; specified mixtures of the gases listed above; air for driving surgical tools; nitrogen for driving surgical tools; oxygen-enriched air.
The types of low-pressure regulators covered by ISO 10524-4:2008 are as follows:
low-pressure regulators intended to be connected to terminal units of medical gas pipeline systems complying with ISO 7396-1;
low-pressure regulators with integral flow-metering devices intended to be connected to terminal units of medical gas pipeline systems complying with ISO 7396-1;
low-pressure regulators intended to be connected to terminal units attached to pressure regulators complying with ISO 10524-1 or ISO 10524-3;
operator-adjustable low-pressure regulators for air or nitrogen for driving surgical tools that are an integral part of a medical gas pipeline system complying with ISO 7396-1."

(source: https://www.iso.org/iso/catalogue_detail.htm?csnumber=41931)

ISO 15002:2008

Flow-metering devices for connection to terminal units of medical gas pipeline systems

"Applies to flow-metering devices that are connected, either directly or by means of flexible connecting assemblies, and disconnected by the operator at terminal units of a medical gas pipeline system for flow adjustment, measurement and delivery of medical gases;
flow-metering devices that are connected and disconnected by the operator at gas-specific connection points of devices such as pressure regulators."

(source: https://www.iso.org/iso/catalogue_detail.htm?csnumber=42057)

ISO 7396-1:2007

Medical gas pipeline systems -- Part 1: Pipeline systems for compressed medical gases and vacuum

(source: https://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=40440)