Medical electrical equipment — Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment

Lung ventilators – Part 3: Particular requirements for emergency and transport ventilators

DIN EN 794-3:2009-12 (E)
Lung ventilators – Part 3: Particular requirements for emergency and transport
ventilators (includes Amendment A2:2009)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….4
Introduction ……………………………………………………………………………………………………………………………………5
Section one. General ………………………………………………………………………………………………………………………6
1 Scope ……………………………………………………………………………………………………………………………..6
2 Normative references ……………………………………………………………………………………………………..6
3 Terminology and definitions ……………………………………………………………………………………………7
4 General requirements and general requirements for tests ………………………………………………..8
5 Classification ………………………………………………………………………………………………………………….9
6 Identification, marking and documents ……………………………………………………………………………9
7 Power input …………………………………………………………………………………………………………………..15
8 Basic safety categories …………………………………………………………………………………………………16
9 Removable protective means ………………………………………………………………………………………..16
10 Environmental conditions ……………………………………………………………………………………………..16
11 Not used ……………………………………………………………………………………………………………………….17
12 Not used ……………………………………………………………………………………………………………………….17
13 General …………………………………………………………………………………………………………………………18
14 Requirements related to classification …………………………………………………………………………..18
15 Limitation of voltage and/or energy ……………………………………………………………………………….18
16 Enclosures and protective covers ………………………………………………………………………………….18
17 Separation …………………………………………………………………………………………………………………….18
18 Protective earthing, functional earthing and potential equalization …………………………………18
19 Continuous leakage currents and patient auxiliary currents …………………………………………..18
20 Dielectric strength …………………………………………………………………………………………………………18
21 Mechanical strength ………………………………………………………………………………………………………19
22 Moving parts …………………………………………………………………………………………………………………20
23 Surfaces, corners and edges …………………………………………………………………………………………20

24 Stability in normal use …………………………………………………………………………………………………. 20
25 Expelled parts ……………………………………………………………………………………………………………… 20
26 Vibration and noise ……………………………………………………………………………………………………… 20
27 Pneumatic and hydraulic power …………………………………………………………………………………… 20
28 Suspended masses ……………………………………………………………………………………………………… 20
29 X-radiation …………………………………………………………………………………………………………………… 21
30 Alpha, beta, gamma, neutron radiation and other particle radiation ………………………………. 21
31 Microwave radiation …………………………………………………………………………………………………….. 21
32 Light radiation (including lasers) ………………………………………………………………………………….. 21
33 Infra-red radiation ………………………………………………………………………………………………………… 21
34 Ultra-violet radiation …………………………………………………………………………………………………….. 21
35 Acoustical energy (including ultra-sonics) ……………………………………………………………………. 21
36 Electromagnetic compatibility ……………………………………………………………………………………… 21
37 Locations and basic requirements ……………………………………………………………………………….. 23
38 Marking, accompanying documents …………………………………………………………………………….. 23
39 Common requirements for Category AP and Category APG equipment ………………………… 23
40 Requirements and test for Category AP equipment, parts and components thereof ………. 23
41 Requirements and test for Category APG equipment, parts and components thereof ……. 23
42 Excessive temperatures ………………………………………………………………………………………………. 24
43 R) Fire prevention ………………………………………………………………………………………………………… 24
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and
disinfection ………………………………………………………………………………………………………………….. 24
45 Pressure vessels and parts subject to pressure ……………………………………………………………. 24
46 Not used ……………………………………………………………………………………………………………………… 25
47 Not used ……………………………………………………………………………………………………………………… 25
48 Biocompatibility …………………………………………………………………………………………………………… 25
49 Interruption of the power supply ………………………………………………………………………………….. 25
50 Accuracy of operating data ………………………………………………………………………………………….. 26
51 Protection against hazardous output ……………………………………………………………………………. 26
52 Abnormal operation and fault conditions ……………………………………………………………………… 30
53 Environmental tests …………………………………………………………………………………………………….. 30

54 General …………………………………………………………………………………………………………………………31
55 Enclosures and covers ………………………………………………………………………………………………….31
56 Components and general assembly ……………………………………………………………………………….31
57 Mains parts, components and layout ……………………………………………………………………………..34
58 Protective earthing – Terminals and connections ……………………………………………………………34
59 Construction and layout ………………………………………………………………………………………………..34
Annex AA (informative) Rationale …………………………………………………………………………………………………35
Annex BB (normative) Legibility and visibility ……………………………………………………………………………….40
Annex CC (informative) Bibliography ……………………………………………………………………………………………41
Annex DD (normative) Special national conditions ………………………………………………………………………..42
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC ……………………………………………………………………….43

EN 1282-2:2005+A1:2009: Tracheostomy tubes – Part 2: Paediatric tubes (ISO 5366-3:2001, modified)

DIN EN 1282-2:2009-12 (E)
Tracheostomy tubes – Part 2: Paediatric tubes (ISO 5366-3:2001, modified) (includes
Amendment A1:2009)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..5
4 Size designation and dimensions ……………………………………………………………………………………6
4.1 Designation of size of tube ……………………………………………………………………………………………..6
4.2 Outside diameter …………………………………………………………………………………………………………….6
4.3 Length ……………………………………………………………………………………………………………………………7
4.4 Angle ……………………………………………………………………………………………………………………………..8
5 Materials …………………………………………………………………………………………………………………………8
6 Design and finish ……………………………………………………………………………………………………………8
6.1 Machine end ……………………………………………………………………………………………………………………8
6.2 Paediatric tracheostomy tube connector …………………………………………………………………………8
6.3 Inner tube ……………………………………………………………………………………………………………………….9
6.4 Neck-plate …………………………………………………………………………………………………………………….10
6.5 Cuff ………………………………………………………………………………………………………………………………10
6.6 Inflating tubes for cuffs …………………………………………………………………………………………………10
6.7 Patient end ……………………………………………………………………………………………………………………10
6.8 Introducer ……………………………………………………………………………………………………………………..10
7 Requirements for tracheostomy tubes supplied sterile …………………………………………………..11
7.1 Sterility assurance ………………………………………………………………………………………………………..11
7.2 Packaging for tracheostomy tubes supplied sterile ………………………………………………………..11
8 Marking …………………………………………………………………………………………………………………………11
8.1 Marking of tracheostomy tube ……………………………………………………………………………………….11
8.2 Marking of tracheostomy tube connectors …………………………………………………………………….11
8.3 Marking of unit packs ……………………………………………………………………………………………………11
9 Adaptor …………………………………………………………………………………………………………………………13
Annex A (normative) Test for security of attachment of permanently attached connector, if
provided, and neck-plate to tracheostomy tube ……………………………………………………………..14
A.1 Principle ……………………………………………………………………………………………………………………….14
A.2 Apparatus ……………………………………………………………………………………………………………………..14
A.3 Procedure ……………………………………………………………………………………………………………………..14
A.4 Expression of results …………………………………………………………………………………………………….15
Annex B (normative) Test method for determining the resting diameter of the cuff ………………………..16
B.1 Principle ……………………………………………………………………………………………………………………….16
B.2 Apparatus ……………………………………………………………………………………………………………………..16

B.3 Procedure ……………………………………………………………………………………………………………………. 16
B.4 Expression of results …………………………………………………………………………………………………… 16
Annex C (informative) Guidance on materials and design ……………………………………………………………. 17
C.1 Materials ……………………………………………………………………………………………………………………… 17
C.2 Design …………………………………………………………………………………………………………………………. 17
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical devices …………………………………………….. 18
Bibliography ……………………………………………………………………………………………………………………………….. 20

EN 1782:1998+A1:2009: Tracheal tubes and connectors

Anaesthetic reservoir bags (ISO 5362:2000, modified)

DIN EN 1820:2009-12 (E)
Anaesthetic reservoir bags (ISO 5362:2000, modified) (includes Amendment A1:2009)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….4
Introduction ……………………………………………………………………………………………………………………………………5
1 Scope ……………………………………………………………………………………………………………………………..6
2 Normative references ……………………………………………………………………………………………………..6
3 Terms and definitions ……………………………………………………………………………………………………..6
4 General requirements ……………………………………………………………………………………………………..7
5 Prevention of electrostatic charges …………………………………………………………………………………9
6 Requirements for bags supplied sterile ……………………………………………………………………………9
7 Marking …………………………………………………………………………………………………………………………..9
8 Information to be supplied by the manufacturer …………………………………………………………….10
Annex A (informative) Test for leakage ………………………………………………………………………………………….11
A.1 Principle ……………………………………………………………………………………………………………………….11
A.2 Apparatus ……………………………………………………………………………………………………………………..11
A.3 Procedure ……………………………………………………………………………………………………………………..11
A.4 Expression of results …………………………………………………………………………………………………….11
Annex B (normative) Determination of capacity …………………………………………………………………………….12
B.1 Principle ……………………………………………………………………………………………………………………….12
B.2 Apparatus ……………………………………………………………………………………………………………………..12
B.3 Procedure ……………………………………………………………………………………………………………………..12
B.4 Expression of results …………………………………………………………………………………………………….12
Annex C (normative) Test for security of attachment of plain neck to 22 mm male conical
connector 13 C.1 Principle …………………………………………………………………………………………….13
C.2 Apparatus and materials ……………………………………………………………………………………………….13
C.3 Procedure ……………………………………………………………………………………………………………………..13
Annex D (normative) Test for security of attachment of adaptor of assembled neck to bag ……………14
D.2 Apparatus ……………………………………………………………………………………………………………………..14
D.3 Procedure ……………………………………………………………………………………………………………………..14
Annex E (normative) Test for resistance to pressure required to distend the bag
(pressure/volume). 15 E.1 Principle ……………………………………………………………………………….15
E.2 Apparatus ……………………………………………………………………………………………………………………..15
E.3 Procedure ……………………………………………………………………………………………………………………..15
E.4 Expression of results …………………………………………………………………………………………………….15

Annex F (informative) Test for resistance to pressure required to distend the bag using air
(pressure/volume) ……………………………………………………………………………………………………….. 16
F.1 Principle ………………………………………………………………………………………………………………………. 16
F.2 Apparatus ……………………………………………………………………………………………………………………. 16
F.3 Procedure ……………………………………………………………………………………………………………………. 16
F.4 Expression of results …………………………………………………………………………………………………… 16
Annex G (informative) Recommendations for materials ……………………………………………………………….. 17
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical devices …………………………………………….. 18
Bibliography ……………………………………………………………………………………………………………………………….. 20

Anaesthetic and respiratory equipment – Vocabulary (ISO 4135:2001)

DIN EN ISO 4135:2002-03 (D/E/F)
Anästhesie- und Beatmungsgeräte_- Begriffe (ISO_4135:2001); Dreisprachige Fassung EN_ISO_4135:2001
Anaesthetic and respiratory equipment_- Vocabulary (ISO_4135:2001); Trilingual version EN_ISO_4135:2001
Matériel d’anesthésie et de réanimation respiratoire_- Vocabulaire (ISO_4135:2001); Version trilingue EN_ISO_4135:2001
– 1 –
Contents
Page
Foreword . . . . . . . . . . . . . . . . . . . . . 2
Scope . . . . . . . . . . . . . . . . . . . . . . . . 3
1 Medical gas supply systems . . 3
2 Anaesthetic machines and
workstations for use with
humans . . . . . . . . . . . . . . . . . . . . 8
3 Ventilators and resuscitators . .10
4 Breathing systems . . . . . . . . . .17
5 Humidifiers, nebulizers and
moisture exchangers . . . . . . . .22
6 Airways, tracheal tubes,
tracheostomy tubes and
intubation equipment . . . . . . . .26
7 Anaesthetic gas scavenging
systems . . . . . . . . . . . . . . . . . . .30
8 Suction devices . . . . . . . . . . . . .30
9 Monitoring . . . . . . . . . . . . . . . . .33
Bibliography . . . . . . . . . . . . . . . . . .37
Alphabetical index . . . . . . . . . . . . .41
Inhalt
Seite
Vorwort . . . . . . . . . . . . . . . . . . . . . . . 2
Anwendungsbereich . . . . . . . . . . . . 3
1 Versorgungsanlagen für medizinische
Gase . . . . . . . . . . . . . . . . . 3
2 Anästhesiegeräte und Anästhesiearbeitsplätze
zur Anwendung am
Menschen . . . . . . . . . . . . . . . . . . 8
3 Beatmungsgeräte und
Wiederbelebungsgeräte . . . . . .10
4 Atemsysteme . . . . . . . . . . . . . . .17
5 Anfeuchter, Vernebler und
Feuchtigkeitsaustauscher . . . .22
6 Atemwege, Trachealtuben,
Tracheotomietuben und
Intubationsausstattung . . . . . . .26
7 Anästhesiegas-Fortleitungssysteme
. . . . . . . . . . . . . . . . . . .30
8 Absauggeräte . . . . . . . . . . . . . .30
9 Überwachung . . . . . . . . . . . . . .33
Literaturhinweise . . . . . . . . . . . . . . .37
Stichwortverzeichnis . . . . . . . . . . .38
Sommaire
Page
Avant-propos . . . . . . . . . . . . . . . . . 2
Domaine d’application . . . . . . . . . . 3
1 Systèmes de distribution de gaz
médicaux . . . . . . . . . . . . . . . . . . 3
2 Appareils d’anesthésie et
système d’anesthésie pour
utilisation chez l’homme . . . . . 8
3 Ventilateurs et ressuscitateurs10
4 Systèmes respiratoires . . . . . .17
5 Humidificateurs, nébuliseurs et
échangeurs d’humidité . . . . . . . 22
6 Voies aériennes, sondes
trachéales, canules de trachéotomie
et matériel d’intubation .26
7 Systèmes d’évacuation des
gaz d’anesthésie . . . . . . . . . . . .30
8 Dispositifs d’aspiration . . . . . .30
9 Monitorage . . . . . . . . . . . . . . . . .33
Bibliographie . . . . . . . . . . . . . . . . . .37
Index alphabétique . . . . . . . . . . . . .44

Anaesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets (ISO 5356-1:2004)

Abstract

ISO 5356-1:2004 specifies dimensional and gauging requirements for cones and sockets intended for connecting anaesthetic and respiratory equipment, e.g. in breathing systems, anaesthetic-gas scavenging systems and vaporizers.

ISO 5356-1:2004 gives requirements for the following conical connectors:

• 8,5 mm sizes intended for use in paediatric breathing systems;
• 15 mm and 22 mm sizes intended for general use in breathing systems;
• 22 mm latching connectors (including performance requirements);
• 23 mm size intended for use with vaporizers, but not for use in breathing systems;
• 30 mm size intended for the connection of a breathing system to an anaesthetic gas scavenging system.

ISO 5356-1:2004 does not specify the medical devices and accessories on which these connections are to be provided.

Requirements for the application of conical connectors are not included in ISO 5356-1:2004, but are or will be given in the relevant International Standards for specific medical devices and accessories.

NOTE Requirements for screw-threaded weight-bearing conical connectors are specified in ISO 5356-2.

Anaesthetic and respiratory equipment – Conical connectors – Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2006)

Abstract

ISO 5356-2:2012 specifies dimensional requirements for screw-threaded weight-bearing conical connectors intended for use with inhalation anaesthesia apparatus and ventilators. Such connectors are intended for mounting heavy accessories.

ISO 5356-2:2012 specifies requirements for the following screw-threaded, weight-bearing conical connectors:

• 22 mm connectors;
• 22/15 mm coaxial connectors.

DIN EN ISO 5356-2:2013-03 (E)
Anaesthetic and respiratory equipment – Conical connectors – Part 2: Screw-threaded
weight-bearing connectors (ISO 5356-2:2012)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………. 3
Introduction …………………………………………………………………………………………………………………………………… 4
1 Scope …………………………………………………………………………………………………………………………….. 5
2 Normative references …………………………………………………………………………………………………….. 5
3 Terms and definitions …………………………………………………………………………………………………….. 5
4 Design …………………………………………………………………………………………………………………………… 6
Bibliography ………………………………………………………………………………………………………………………………….. 9

Anaesthetic vaporizers – Agent-specific filling systems (ISO 5360:2006)

Abstract

ISO 5360:2012 specifies requirements, including dimensions, for agent-specific filling systems for agent-specific anaesthetic vaporizers.

ISO 5360:2012 does not specify construction materials. Because of the unique properties of desflurane, dimensions for this agent have not been specified in ISO 5360:2012.

DIN EN ISO 5360:2012-04 (E)
Anaesthetic vaporizers – Agent-specific filling systems (ISO 5360:2012)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………. 3
1 Scope …………………………………………………………………………………………………………………………….. 4
2 Normative references …………………………………………………………………………………………………….. 4
3 Terms and definitions …………………………………………………………………………………………………….. 4
4 Bottle …………………………………………………………………………………………………………………………….. 5
5 Bottle collar ……………………………………………………………………………………………………………………. 7
6 Bottle adaptor ………………………………………………………………………………………………………………. 10
7 Filler receptacle ……………………………………………………………………………………………………………. 14
8 Filling rate ……………………………………………………………………………………………………………………. 16
9 Leakage ……………………………………………………………………………………………………………………….. 18
10 Overfilling protection ……………………………………………………………………………………………………. 18
11 Colour coding ………………………………………………………………………………………………………………. 18
12 Usability ………………………………………………………………………………………………………………………. 18
13 Clinical evaluation ………………………………………………………………………………………………………… 18
14 Information provided by the manufacturer ……………………………………………………………………. 19
14.1 Marking ………………………………………………………………………………………………………………………… 19
14.2 Labelling ………………………………………………………………………………………………………………………. 19
14.3 Instructions for use ………………………………………………………………………………………………………. 19
Annex A (informative) Recommendations on materials ………………………………………………………………… 21
Annex B (informative) Types of agent-specific filling systems ………………………………………………………. 22
Annex C (normative) Determination of total leakage into atmosphere of anaesthetic agent during
filling ……………………………………………………………………………………………………………………………. 23
Bibliography ………………………………………………………………………………………………………………………………… 24

Anaesthetic and respiratory equipment – Tracheostomy tubes – Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)

DIN EN ISO 5366-1:2009-07 (D)
Anästhesie- und Beatmungsgeräte – Tracheotomietuben – Teil 1: Tuben und
Verbindungsstücke zur Anwendung bei Erwachsenen (ISO 5366-1:2000); Deutsche
Fassung EN ISO 5366-1:2009
Inhalt Seite
Vorwort …………………………………………………………………………………………………………………………………………….3
Einleitung …………………………………………………………………………………………………………………………………………4
1 Anwendungsbereich ……………………………………………………………………………………………………………..5
2 Normative Verweisungen ………………………………………………………………………………………………………5
3 Begriffe …………………………………………………………………………………………………………………………………5
4 Größen und Maße………………………………………………………………………………………………………………….8
4.1 Innendurchmesser ………………………………………………………………………………………………………………..8
4.2 Außendurchmesser……………………………………………………………………………………………………………….9
4.3 Länge ……………………………………………………………………………………………………………………………………9
4.4 Winkel θ ………………………………………………………………………………………………………………………………..9
5 Werkstoffe …………………………………………………………………………………………………………………………..10
6 Ausführung …………………………………………………………………………………………………………………………10
6.1 Maschinenende……………………………………………………………………………………………………………………10
6.2 Halsplatte ……………………………………………………………………………………………………………………………10
6.3 Innentubus ………………………………………………………………………………………………………………………….10
6.4 Cuff……………………………………………………………………………………………………………………………………..10
6.5 Füllschläuche für Cuffs………………………………………………………………………………………………………..11
6.6 Patientenende……………………………………………………………………………………………………………………..11
6.7 Einführhilfe………………………………………………………………………………………………………………………….11
7 Anforderungen an steril gelieferte Tracheotomietuben…………………………………………………………11
7.1 Zusicherung von Sterilität ……………………………………………………………………………………………………11
7.2 Verpackung steril gelieferter Tracheotomietuben …………………………………………………………………12
8 Kennzeichnung……………………………………………………………………………………………………………………12
8.1 Allgemeines ………………………………………………………………………………………………………………………..12
8.2 Kennzeichnung der Halsplatte……………………………………………………………………………………………..12
8.3 Kennzeichnung der Einzelpackungen…………………………………………………………………………………..12
Anhang A (normativ) Prüfung der sicheren Befestigung eines Verbindungsstücks und einer
Halsplatte am Tracheotomietubus………………………………………………………………………………………..14
Anhang B (normativ) Bestimmung des Durchmessers des gefüllten,
jedoch nicht gedehnten Cuffs………………………………………………………………………………………………15
Anhang C (informativ) Leitfaden für Werkstoffe und Ausführung………………………………………………………16
Literaturhinweise…………………………………………………………………………………………………………………………….17
Anhang ZA (informativ) Zusammenhang zwischen dieser Europäischen Norm und den
grundlegenden Anforderungen der EG-Richtlinie 93/42/EWG ……………………………………………….18