Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment – Lock fittings

DIN EN 1707:1997-01 (D)
Kegelverbindungen mit einem 6 % (Luer) Kegel für Spritzen, Kanülen und bestimmte
andere medizinische Geräte – Verriegelbare Kegelverbindungen; Deutsche Fassung
EN 1707:1996
Inhalt Seite
Vorwort ……………………………………………………………………………………………………………………………………….. 2
1 Anwendungsbereich ………………………………………………………………………………………………………………….. 2
2 Normative Venweisungen …………………………………………………………………………………………………………… 2
3 Maße und Grenzabmaße …………………………………………………………………………………………………………….. 2
4 Anforderungen …………………………………………………………………………………………………………………………… 3
5 Prüfverfahren …………………………………………………………………………………………………………………………….. 3
Anhang ZA (informativ) Abschnitte in dieser Europäischen Norm, die grundlegende
Anforderungen oder andere Vorgaben von EU-Richtlinien betreffen …………………………… 10

Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)

Abstract

 

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) connectors.

DIN EN ISO 5359:2012-04 (E)
Low-pressure hose assemblies for use with medical gases (ISO 5359:2008 + Amd
1:2011) (includes Amendment A1:2011)
Contents Page
Introduction …………………………………………………………………………………………………………………………………… 6
0.1 General ………………………………………………………………………………………………………………………….. 6
0.2 Standardization of screw-threaded connectors for use in hose assemblies …………………….. 6
1 Scope …………………………………………………………………………………………………………………………….. 8
2 Normative references …………………………………………………………………………………………………….. 9
3 Terms and definitions …………………………………………………………………………………………………….. 9
4 General requirements …………………………………………………………………………………………………… 12
4.1 Safety …………………………………………………………………………………………………………………………… 12
4.2 * Alternative construction …………………………………………………………………………………………….. 13
4.3 Materials ………………………………………………………………………………………………………………………. 13
4.4 Design requirements …………………………………………………………………………………………………….. 13
4.4.1 Hose internal diameter …………………………………………………………………………………………………. 13
4.4.2 Mechanical strength ……………………………………………………………………………………………………… 13
4.4.3 Deformation under pressure …………………………………………………………………………………………. 14
4.4.4 Resistance to occlusion ……………………………………………………………………………………………….. 14
4.4.5 Adhesion strength ………………………………………………………………………………………………………… 14
4.4.6 Flexibility ……………………………………………………………………………………………………………………… 14
4.4.7 Gas-specificity ……………………………………………………………………………………………………………… 14
4.4.8 End connectors ……………………………………………………………………………………………………………. 15
4.4.9 Design of NIST connectors …………………………………………………………………………………………… 15
4.4.10 Design of DISS connectors …………………………………………………………………………………………… 15
4.4.11 Design of SIS connectors ……………………………………………………………………………………………… 23
4.4.12 Joining hoses to hose inserts ………………………………………………………………………………………. 23
4.4.13 Leakage ……………………………………………………………………………………………………………………….. 24
4.4.14 * Pressure drop …………………………………………………………………………………………………………….. 24
4.4.15 Expulsion of nipple ………………………………………………………………………………………………………. 24
4.5 Constructional requirements ………………………………………………………………………………………… 24
4.5.1 * Cleaning …………………………………………………………………………………………………………………….. 24
4.5.2 * Lubricants ………………………………………………………………………………………………………………….. 25
5 Test methods ……………………………………………………………………………………………………………….. 25
5.1 General ………………………………………………………………………………………………………………………… 25
5.1.1 Ambient conditions ………………………………………………………………………………………………………. 25
5.1.2 Test gas ……………………………………………………………………………………………………………………….. 25
5.1.3 Reference conditions ……………………………………………………………………………………………………. 25
5.2 Test method for pressure drop ……………………………………………………………………………………… 25
5.3 Test method for leakage ……………………………………………………………………………………………….. 25
5.3.1 For all hose assemblies ………………………………………………………………………………………………… 25
5.3.2 For hose assemblies fitted with a hose assembly check valve ………………………………………. 25
5.4 Test method for gas-specificity …………………………………………………………………………………….. 25
5.5 Test method for mechanical strength ……………………………………………………………………………. 26
5.6 Test method for deformation under pressure ………………………………………………………………… 26
5.7 Test method for resistance to occlusion ……………………………………………………………………….. 26
5.8 Test method for durability of markings and colour coding …………………………………………….. 28
6 Marking, colour coding and packaging …………………………………………………………………………. 28

6.1 Marking ……………………………………………………………………………………………………………………….. 28
6.2 Colour coding ……………………………………………………………………………………………………………… 29
6.3 Packaging ……………………………………………………………………………………………………………………. 29
7 Information to be supplied by the manufacturer ……………………………………………………………. 29
Annex A (informative) Rationale ………………………………………………………………………………………………….. 31
Annex B (informative) Environmental aspects ……………………………………………………………………………… 32
Annex C (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases …………………………………………………………………………………… 33
Bibliography ……………………………………………………………………………………………………………………………….. 35
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC ……………………………………………………………………… 36

Medical gas pipeline systems – Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)

Abstract

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.

DIN EN ISO 7396-1:2010-08 (E)
Medical gas pipeline systems – Part 1: Pipeline systems for comp ressed medical
gases and vacuum (ISO 7396-1:2007 + Amd 1:2010 + Amd 2:2010) (includes
Amendment A1:2010 + Amendment A2:2010)
Contents Page
Introduction ……………………………………………………………………………………………………………………………………6
1 Scope ……………………………………………………………………………………………………………………………..7
2 Normative references ……………………………………………………………………………………………………..8
3 Terms and definitions ……………………………………………………………………………………………………..8
4 General requirements ……………………………………………………………………………………………………13
4.1 (*) Safety ……………………………………………………………………………………………………………………….13
4.2 (*) Alternative construction ……………………………………………………………………………………………13
4.3 Materials ……………………………………………………………………………………………………………………….14
4.4 System design ………………………………………………………………………………………………………………15
5 Supply systems …………………………………………………………………………………………………………….16
5.1 System components ……………………………………………………………………………………………………..16
5.2 General requirements ……………………………………………………………………………………………………16
5.3 Supply systems with cylinders or cylinder bundles ……………………………………………………….18
5.4 Supply systems with mobile or stationary cryogenic or non-cryogenic vessels ……………..19
5.5 Supply systems for air …………………………………………………………………………………………………..19
5.6 Supply systems with oxygen concentrator(s) ………………………………………………………………..23
5.7 Supply systems for vacuum ………………………………………………………………………………………….24
5.8 Location of supply systems …………………………………………………………………………………………..24
5.9 Location of cylinder manifolds ………………………………………………………………………………………25
5.10 Location of stationary cryogenic vessels ………………………………………………………………………25
6 Monitoring and alarm systems ………………………………………………………………………………………25
6.1 General …………………………………………………………………………………………………………………………25
6.2 Installation requirements ………………………………………………………………………………………………25
6.3 Monitoring and alarm signals ………………………………………………………………………………………..26
6.4 Provision of operating alarms ……………………………………………………………………………………….27
6.5 Provision of emergency clinical alarms ………………………………………………………………………….28
6.6 (*) Provision of emergency operating alarms …………………………………………………………………28
7 Pipeline distribution systems ………………………………………………………………………………………..28
7.1 Mechanical resistance …………………………………………………………………………………………………..28
7.2 Distribution pressure …………………………………………………………………………………………………….28
7.3 Low-pressure hose assemblies and low-pressure flexible connections ………………………….29
7.4 Double-stage pipeline distribution systems …………………………………………………………………..30
8 Shut-off valves ………………………………………………………………………………………………………………30
8.1 General …………………………………………………………………………………………………………………………30
8.2 Service shut-off valves ………………………………………………………………………………………………….31
8.3 Area shut-off valves ………………………………………………………………………………………………………31
9 Terminal units, gas-specific connectors, medical supply units, pressure regulators and
pressure gauges ……………………………………………………………………………………………………………32
10 Marking and colour coding ……………………………………………………………………………………………33

10.1 Marking ……………………………………………………………………………………………………………………….. 33
10.2 Colour coding ……………………………………………………………………………………………………………… 33
11 Pipeline installation ……………………………………………………………………………………………………… 33
11.1 General ……………………………………………………………………………………………………………………….. 33
11.2 Pipeline supports …………………………………………………………………………………………………………. 34
11.3 Pipeline joints ……………………………………………………………………………………………………………… 35
11.4 Extensions and modifications of existing pipeline systems ………………………………………….. 35
12 Testing, commissioning and certification …………………………………………………………………….. 35
12.1 General ……………………………………………………………………………………………………………………….. 35
12.2 General requirements for tests …………………………………………………………………………………….. 36
12.3 Inspections and checks before concealment ………………………………………………………………… 36
12.4 Tests, checks and procedures before use of the system ………………………………………………. 36
12.5 Requirements for inspections and checks before concealment …………………………………….. 37
12.6 Requirements for tests, checks and procedures before use of the system ……………………. 37
12.7 Certification of the systems …………………………………………………………………………………………. 42
13 Information to be supplied by the manufacturer ……………………………………………………………. 43
13.1 General ……………………………………………………………………………………………………………………….. 43
13.2 Instructions for use ……………………………………………………………………………………………………… 43
13.3 Operational management information …………………………………………………………………………… 44
13.4 “As-installed” drawings ……………………………………………………………………………………………….. 44
13.5 Electrical diagrams ………………………………………………………………………………………………………. 44
Annex A (informative) Schematic representations of typical supply systems and area distribution
systems ………………………………………………………………………………………………………………………. 45
Annex B (informative) Guidelines for location of cylinder manifolds, cylinder storage areas and
stationary vessels for cryogenic or non-cryogenic liquids ……………………………………………. 68
Annex C (informative) Example of procedure for testing and commissioning ……………………………….. 69
Annex D (informative) Typical forms for certification of the medical gas pipeline system ……………… 81
Annex E (informative) Temperature and pressure relationships …………………………………………………. 111
Annex F (informative) Risk management checklist …………………………………………………………………….. 113
Annex G (informative) Operational management ………………………………………………………………………… 126
Annex H (informative) Rationale ………………………………………………………………………………………………… 144
Bibliography ……………………………………………………………………………………………………………………………… 146
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical devices ……………………………………… 148

Medical gas pipeline systems – Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)

Abstract

ISO 7396-2:2007 specifies requirements for the design, installation, function, performance, documentation, testing and commissioning of anaesthetic gas scavenging disposal systems, to ensure patient safety and to minimize exposure of the operator and other persons to anaesthetic gases and vapours. It includes requirements for the power device, pipeline system, performance, non-interchangeability between key components and avoidance of cross connections between anaesthetic gas scavenging (AGS) disposal systems and medical gas and vacuum pipeline systems.

ISO 7396-2:2007 is applicable only to those disposal systems intended to be connected via AGSS terminal units compliant with ISO 9170-2 to AGSS receiving systems compliant with ISO 8835-3.

ISO 7396-2:2007 also applies to:

• extensions of existing AGSS disposal systems;
• modifications of existing AGSS disposal systems;
• modifications or replacement of power devices.

Oxygen concentrators for medical use – Safety requirements (ISO 8359:1996)

Abstract

 

Based on IEC 601-1. Specifies safety requirements for oxygen concentrators. Does not apply to oxygen concentrators intended to supply gas to several patients via a medical gas pipeline system. Replaces the first edition.

DIN EN ISO 8359:2009-08 (D)
Sauerstoff-Konzentratoren für medizinische Zwecke_- Sicherheitsanforderungen (ISO_8359:1996); Deutsche Fassung EN_ISO_8359:2009
Inhalt Seite
– 1 –
Vorwort…………………………………………………………………………………………………………………………………………….4
Einleitung………………………………………………………………………………………………………………………………………….5
Hauptabschnitt eins — Allgemeines…………………………………………………………………………………………………..6
1.1 Anwendungsbereich……………………………………………………………………………………………………………..6
1.2 Normative Verweisungen……………………………………………………………………………………………………….6
1.3 Begriffe…………………………………………………………………………………………………………………………………6
1.4 Allgemeine Anforderungen…………………………………………………………………………………………………….7
1.5 Allgemeine Anforderungen für die Prüfungen………………………………………………………………………..7
1.6 Klassifikation…………………………………………………………………………………………………………………………7
1.7 Bezeichnungen, Aufschriften und Begleitpapiere…………………………………………………………………..8
1.8 Strom- bzw. Leistungsaufnahme………………………………………………………………………………………….10
Hauptabschnitt zwei — Sicherheitsanforderungen…………………………………………………………………………..10
2.1 Grundlegende Sicherheitsanforderungen…………………………………………………………………………….10
2.2 Abnehmbare Schutzvorrichtungen……………………………………………………………………………………….10
2.3 Umweltbedingungen ……………………………………………………………………………………………………………10
Hauptabschnitt drei — Schutz gegen die Gefahren eines elektrischen Schlages………………………………10
3.1 Allgemeines…………………………………………………………………………………………………………………………10
3.2 Anforderungen in Bezug auf die Einteilung der Geräte………………………………………………………….10
3.3 Begrenzung von Spannung und/oder Energie………………………………………………………………………10
3.4 Gehäuse und Schutzabdeckungen……………………………………………………………………………………….11
3.5 Trennung …………………………………………………………………………………………………………………………….11
3.6 Schutzleiteranschluss, Betriebserdung und Potentialausgleich……………………………………………11
3.7 Dauer-, Ableit- und Patientenhilfsströme………………………………………………………………………………11
3.8 Spannungsfestigkeit ……………………………………………………………………………………………………………11
Hauptabschnitt vier — Schutz gegen mechanische Gefährdung……………………………………………………….11
4.1 Mechanische Festigkeit ……………………………………………………………………………………………………….11
4.2 Bewegte Teile………………………………………………………………………………………………………………………11
4.3 Oberflächen, Ecken und Kanten …………………………………………………………………………………………..11
4.4 Standfestigkeit bei bestimmungsgemäßem Gebrauch…………………………………………………………..11
4.5 Herausgeschleuderte Teile…………………………………………………………………………………………………..11
4.6 Erschütterungen und Geräusche………………………………………………………………………………………….12
4.7 Pneumatische und hydraulische Energie……………………………………………………………………………..12
4.8 Aufgehängte Massen……………………………………………………………………………………………………………12
Hauptabschnitt fünf — Schutz gegen Gefahren durch unerwünschte oder übermäßige Strahlung…….12
5.1 Röntgenstrahlung………………………………………………………………………………………………………………..12
5.2 Alpha-, Beta-, Gamma- und Neutronenstrahlung sowie sonstige Korpuskularstrahlung………..12
5.3 Mikrowellenstrahlung…………………………………………………………………………………………………………..12
5.4 Lichtstrahlung (einschließlich sichtbarer Strahlung und Laserstrahlen)………………………………..12
5.5 Infrarotstrahlung………………………………………………………………………………………………………………….12
5.6 Ultraviolettstrahlung…………………………………………………………………………………………………………….13
5.7 Schallenergie (einschließlich Ultraschall)……………………………………………………………………………..13
5.8 Elektromagnetische Verträglichkeit………………………………………………………………………………………13
Hauptabschnitt sechs — Schutz gegen Explosionsgefahren in medizinisch genutzten Räumen……….13
6.1 Bereiche und grundlegende Anforderungen…………………………………………………………………………13
6.2 Aufschriften, Begleitpapiere…………………………………………………………………………………………………13
6.3 Gemeinsame Anforderungen an Geräte der Klasse AP und APG…………………………………………..13
6.4 Anforderungen und Prüfungen für Geräte der Klasse AP, ihre Geräteteile und Bauteile………..13
6.5 Anforderungen und Prüfungen für Geräte der Klasse APG, ihre Geräteteile und Bauteile………13

Hauptabschnitt sieben — Schutz gegen übermäßige Temperaturen und andere Gefährdungen………..14
7.1 Übermäßige Temperaturen…………………………………………………………………………………………………..14
7.2 Brandverhütung…………………………………………………………………………………………………………………..14
7.3 Überlaufen, Verschütten, Auslaufen, Feuchte, Eindringen von Flüssigkeiten, Reinigung, Sterilisa
7.4 Druckgefäße und durch Druckbeanspruchte Teile………………………………………………………………..15
7.5 Menschliches Versagen……………………………………………………………………………………………………….15
7.6 Elektrostatische Aufladungen………………………………………………………………………………………………15
7.7 Bioverträglichkeit………………………………………………………………………………………………………………..15
7.8 Unterbrechung der Stromversorgung…………………………………………………………………………………..15
Hauptabschnitt acht — Genauigkeit der Betriebsdaten und Schutz gegen gefährdende Ausgangswerte……………………………………………………………………………………………………………………15
8.1 Genauigkeit der Betriebsdaten…………………………………………………………………………………………….15
8.2 Schutz gegen gefährdende Ausgangswerte…………………………………………………………………………17
Hauptabschnitt neun — Nichtbestimmungsgemäßer Betrieb und Fehlerfälle; Umweltprüfungen………18
9.1 Nichtbestimmungsgemäßer Betrieb und Fehlerfälle……………………………………………………………..18
9.2 Umweltprüfungen………………………………………………………………………………………………………………..18
Hauptabschnitt zehn — Konstruktive Anforderungen………………………………………………………………………18
10.1 Allgemeines………………………………………………………………………………………………………………………..18
10.2 Gehäuse und Abdeckungen…………………………………………………………………………………………………18
10.3 Bauteile und Allgemeines zum Zusammenbau……………………………………………………………………..18
10.4 Netzteile, Bauteile und Ausführung………………………………………………………………………………………19
10.5 Schutzleiter — Klemmen undVerbindungen…………………………………………………………………………19
10.6 Aufbau und Anordnung ……………………………………………………………………………………………………….19
Hauptabschnitt elf — Zusätzliche Abschnitte…………………………………………………………………………………..19
11.1 Akustische Anzeiger……………………………………………………………………………………………………………19
11.2 Anzeige des Ausfalls der Netzversorgung……………………………………………………………………………19
Anhang N (normativ) Prüfgerät………………………………………………………………………………………………………..20
Anhang P (informativ) Begründung ………………………………………………………………………………………………….21
Anhang Q (informativ) Literaturhinweise………………………………………………………………………………………….25
Anhang ZA (informativ) Zusammenhang zwischen dieser Europäischen Norm und den
grundlegenden Anforderungen der EG-Richtlinie 93/42/EWG……………………………………………….26

Terminal units for medical gas pipeline systems – Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008)

Abstract

 

ISO 9170-1:2008 applies to:

1. terminal units intended for use in medical gas pipeline systems in accordance with ISO 7396-1, for use with the following medical gases:
   • oxygen,
   • nitrous oxide;
   • medical air;
   • carbon dioxide;
   • oxygen/nitrous oxide mixture [50 %/50 % (by volume)];
2. terminal units intended for use in medical gas pipeline systems in accordance with ISO 7396-1, for use with the following gases and services:
   • oxygen-enriched air;
   • air for driving surgical tools;
   • nitrogen for driving surgical tools;
   • vacuum.

It is intended especially to ensure the gas-specific assembly of terminal units and to prevent their interchange between different gases and services.

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.

DIN EN ISO 9170-1:2008-10 (E)
Terminal units for medical gas pipeline systems – Part 1: Terminal units for use with
compressed medical gases and vacuu m (ISO 9170-1:2008)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 * Normative references ……………………………………………………………………………………………………6
3 Terms and definitions ……………………………………………………………………………………………………..6
4 General requirements ……………………………………………………………………………………………………10
4.1 Safety ……………………………………………………………………………………………………………………………10
4.2 * Alternative construction ……………………………………………………………………………………………..10
4.3 Materials ……………………………………………………………………………………………………………………….10
4.4 Design requirements ……………………………………………………………………………………………………..11
4.5 Constructional requirements …………………………………………………………………………………………14
5 Test methods ………………………………………………………………………………………………………………..15
5.1 General …………………………………………………………………………………………………………………………15
5.2 Test for endurance ………………………………………………………………………………………………………..15
5.3 Test for pressure drop …………………………………………………………………………………………………..16
5.4 Test for connection force and torque …………………………………………………………………………….17
5.5 Test for disconnection force and torque ………………………………………………………………………..18
5.6 Test for mechanical strength …………………………………………………………………………………………18
5.7 Test for leakage …………………………………………………………………………………………………………….18
5.8 Test for gas specificity ………………………………………………………………………………………………….19
5.9 Test for effective connection of probes ………………………………………………………………………….19
5.10 Test for durability of markings and colour coding ………………………………………………………….19
6 Marking, colour coding and packaging ………………………………………………………………………….19
6.1 Marking …………………………………………………………………………………………………………………………19
6.2 Colour coding ……………………………………………………………………………………………………………….20
6.3 Packaging …………………………………………………………………………………………………………………….20
7 Information to be supplied by the manufacturer …………………………………………………………….20
Annex A (informative) Rationale ……………………………………………………………………………………………………21
Annex B (informative) Environmental aspects ………………………………………………………………………………22
Annex C (informative) Special national and regional conditions for electrical installations …………….23
Annex ZA (informative) Correspondence between this International Standard and Directive
93/42/EEC ……………………………………………………………………………………………………………………..24
Bibliography …………………………………………………………………………………………………………………………………26

Terminal units for medical gas pipeline systems – Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)

Abstract

ISO 9170-2:2008 specifies the requirements and dimensions for terminal units intended for use in anaesthetic gas scavenging disposal systems in accordance with ISO 7396-2.

ISO 9170-2:2008 specifies two types of terminal unit according to whether the power device is upstream or downstream of the terminal unit.

ISO 9170-2:2008 also specifies requirements and dimensions for the mating counterpart (probe) of the type-specific connection point which is part of the terminal unit.

DIN EN ISO 9170-2:2009-09 (D)
Entnahmestellen für Rohrleitungssysteme für medizinische Gase – Teil 2:
Entnahmestellen für Anästhesiegas-Fortleitungssysteme (ISO 9170-2:2008);
Deutsche Fassung EN ISO 9170-2:2008
Inhalt Seite
Vorwort …………………………………………………………………………………………………………………………………………….3
Einleitung …………………………………………………………………………………………………………………………………………4
1 Anwendungsbereich ……………………………………………………………………………………………………………..5
2 *Normative Verweisungen ……………………………………………………………………………………………………..5
3 Begriffe …………………………………………………………………………………………………………………………………5
4 Allgemeine Anforderungen ………………………………………………………………………………………………….10
4.1 Sicherheit ……………………………………………………………………………………………………………………………10
4.2 * Alternative Konstruktion ……………………………………………………………………………………………………10
4.3 Werkstoffe …………………………………………………………………………………………………………………………..11
4.4 Anforderungen an die Ausführung……………………………………………………………………………………….11
4.5 Konstruktive Anforderungen ……………………………………………………………………………………………….18
5 Prüfverfahren ………………………………………………………………………………………………………………………18
5.1 Allgemeines ………………………………………………………………………………………………………………………..18
5.2 Prüfung auf Haltbarkeit………………………………………………………………………………………………………..18
5.3 Prüfverfahren für den Druckabfall ………………………………………………………………………………………..19
5.4 Prüfverfahren für die Anschlusskraft……………………………………………………………………………………19
5.5 Prüfverfahren für die Lösungskraft ………………………………………………………………………………………19
5.6 Prüfverfahren für die mechanische Festigkeit ………………………………………………………………………20
5.7 Dichtheitsprüfungen ……………………………………………………………………………………………………………20
5.8 Prüfverfahren für typspezifische Merkmale ………………………………………………………………………….20
5.9 Prüfverfahren für den wirksamen Steckeranschluss …………………………………………………………….20
5.10 Prüfverfahren für Anschlüsse von Aufnahme- oder Entsorgungsschläuchen an
Schlauchnippel ……………………………………………………………………………………………………………………20
5.11 Prüfverfahren für die Haltbarkeit von Aufschriften und Farbcodierungen ……………………………..20
6 Aufschriften, Farbcodierung und Verpackung………………………………………………………………………21
6.1 Aufschriften ………………………………………………………………………………………………………………………..21
6.2 Farbcodierung …………………………………………………………………………………………………………………….21
6.3 Verpackung…………………………………………………………………………………………………………………………21
7 Informationen des Herstellers………………………………………………………………………………………………21
Anhang A (informativ) Begründungen………………………………………………………………………………………………22
Anhang B (informativ) Umweltgesichtspunkte ………………………………………………………………………………….23
Anhang C (informativ) Spezielle nationale und regionale Bedingungen für Elektroinstallationen……….25
Literaturhinweise…………………………………………………………………………………………………………………………….26
Anhang ZA (informativ) Zusammenhang zwischen dieser Europäischen Norm und den
grundlegenden Anforderungen der EG-Richtlinie 93/42/EWG ……………………………………………….27

Pressure regulators for use with medical gases – Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)

DIN EN ISO 10524-1:2006-05 (E)
Pressure regulators for use with medical gases – Part 1: Pressure regulators and
pressure regulators with flow-metering dev ices (ISO 10524-1:2006)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….2
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..6
3 Terms and definitions ……………………………………………………………………………………………………..6
4 Nomenclature …………………………………………………………………………………………………………………8
5 General requirements ……………………………………………………………………………………………………..8
5.1 Safety ……………………………………………………………………………………………………………………………..8
5.2 Alternative construction ………………………………………………………………………………………………….8
5.3 Materials …………………………………………………………………………………………………………………………8
5.4 Design requirements ……………………………………………………………………………………………………….9
5.5 Constructional requirements …………………………………………………………………………………………16
6 Test methods ………………………………………………………………………………………………………………..16
6.1 General …………………………………………………………………………………………………………………………16
6.2 Test methods for outlet pressure …………………………………………………………………………………..17
6.3 Test method for pressure-relief valve …………………………………………………………………………….18
6.4 Test methods for leakage ………………………………………………………………………………………………18
6.5 Test method for mechanical strength …………………………………………………………………………….19
6.6 Test method for resistance to ignition ……………………………………………………………………………19
6.7 Test method for accuracy of flow of pressure regulators fitted with flowmeters or
flowgauges ……………………………………………………………………………………………………………………20
6.8 Test method for the stability of flow of pressure regulators fitted with flowmeters or
flowgauges ……………………………………………………………………………………………………………………20
6.9 Test method for stability and accuracy of flow of pressure regulators fitted with fixed
orifices ………………………………………………………………………………………………………………………….20
6.10 Test method for flow setting and loosening torques ………………………………………………………20
6.11 Test method for durability of markings and colour coding ……………………………………………..20
7 Marking, colour coding, packaging ………………………………………………………………………………..20
7.1 Marking …………………………………………………………………………………………………………………………20
7.2 Colour coding ……………………………………………………………………………………………………………….22
7.3 Packaging …………………………………………………………………………………………………………………….22
8 Information to be supplied by the manufacturer …………………………………………………………….22
Annex A (informative) Typical examples of pressure regulators and pressure regulators with flowmetering
devices …………………………………………………………………………………………………………..26
Annex B (informative) Rationale ……………………………………………………………………………………………………30
Annex C (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases ……………………………………………………………………………………32
Bibliography …………………………………………………………………………………………………………………………………34
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC concerning Medical Devices ………………………….. 35

Pressure regulators for use with medical gases – Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)

DIN EN ISO 10524-2:2006-07 (E)
Pressure regulators for use with medical gases – Part 2: Manifold and line pressure
regulators (ISO 10524-2:2005)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….2
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..6
4 Symbols …………………………………………………………………………………………………………………………8
5 General requirements ……………………………………………………………………………………………………..8
5.1 Safety ……………………………………………………………………………………………………………………………..8
5.2 Alternative construction ………………………………………………………………………………………………….8
5.3 Materials …………………………………………………………………………………………………………………………8
5.4 Design requirements ……………………………………………………………………………………………………….9
5.5 Constructional requirements …………………………………………………………………………………………13
6 Test methods ………………………………………………………………………………………………………………..13
6.1 Conditions …………………………………………………………………………………………………………………….13
6.2 Test methods for manifold pressure regulators ……………………………………………………………..14
6.3 Test methods for line pressure regulators ……………………………………………………………………..20
6.4 Test method for determination of the auto-ignition temperature of sealing materials and
lubricants ……………………………………………………………………………………………………………………..21
6.5 Test method for durability of markings and colour coding ……………………………………………..22
7 Marking, colour coding, packaging ………………………………………………………………………………..23
7.1 Marking …………………………………………………………………………………………………………………………23
7.2 Colour coding ……………………………………………………………………………………………………………….24
7.3 Packaging …………………………………………………………………………………………………………………….25
8 Information to be supplied by the manufacturer …………………………………………………………….25
Annex A (informative) Examples of pressure regulators ………………………………………………………………..26
Annex B (informative) Rationale ……………………………………………………………………………………………………28
Annex C (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases ……………………………………………………………………………………30
Bibliography …………………………………………………………………………………………………………………………………32
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical Devices ……………………………………………..33

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

DIN EN ISO 10524-4:2008-09 (E)
Pressure regulators for use with medical gases – Part 4: Low-pressure regulators
(ISO 10524-4:2008)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 * Normative references ……………………………………………………………………………………………………6
3 Terms and definitions ……………………………………………………………………………………………………..6
4 Nomenclature …………………………………………………………………………………………………………………8
5 General requirements ……………………………………………………………………………………………………..8
5.1 Safety ……………………………………………………………………………………………………………………………..8
5.2 Alternative construction ………………………………………………………………………………………………….8
5.3 Materials …………………………………………………………………………………………………………………………9
5.4 Design requirements ……………………………………………………………………………………………………….9
5.5 Constructional requirements …………………………………………………………………………………………16
6 Test methods ………………………………………………………………………………………………………………..16
6.1 General …………………………………………………………………………………………………………………………16
6.2 Test conditions ……………………………………………………………………………………………………………..17
6.3 Test method for outlet pressure …………………………………………………………………………………….17
6.4 Test methods for leakage ………………………………………………………………………………………………18
6.5 Test method for mechanical strength …………………………………………………………………………….19
6.6 Test method for accuracy of flow of pressure regulators fitted with flowmeters or
flowgauges ……………………………………………………………………………………………………………………19
6.7 Test method for the stability of flow of pressure regulators fitted with flowmeters or
flowgauges ……………………………………………………………………………………………………………………19
6.8 Test method for stability and accuracy of flow of pressure regulators fitted with fixed
orifices ………………………………………………………………………………………………………………………….19
6.9 Test method for loosening torque ………………………………………………………………………………….19
6.10 Test method for durability of markings and colour coding ……………………………………………..19
7 Marking, colour coding, packaging ………………………………………………………………………………..20
7.1 Marking …………………………………………………………………………………………………………………………20
7.2 Colour coding ……………………………………………………………………………………………………………….21
7.3 Packaging …………………………………………………………………………………………………………………….21
8 Information to be supplied by the manufacturer …………………………………………………………….21
Annex A (informative) Typical examples of low-pressure regulators ……………………………………………..23
Annex B (informative) Rationale ……………………………………………………………………………………………………28
Annex C (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases ……………………………………………………………………………………30
Annex D (informative) Environmental aspects ………………………………………………………………………………32
Annex ZA (informative) Correspondence between this International Standard and Directive
93/42/EEC ……………………………………………………………………………………………………………………. 34
Bibliography ……………………………………………………………………………………………………………………………….. 36