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BS EN ISO 10079-2:2014

BS EN ISO 10079-2:2014

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Medical suction equipment – Manually powered suction equipment

Published By Publication Date Number of Pages
BSI 2014 32
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This part of ISO 10079 specifies safety and performance requirements for manually powered suction equipment intended for oro-pharyngeal suction. It applies to equipment operated by foot or by hand or both. Annex D illustrates the three parts of ISO 10079 by providing a schematic for typical systems.

The commonest use of manually powered suction is in situations outside of health care settings often described as field use or transport use. Use in these situations may involve extreme conditions of weather or terrain. Additional requirements for suction equipment intended for field and/or transport use are included in this part of ISO 10079.

This part of ISO 10079 does not apply to the following:

  1. end pieces such as suction catheters, Yankauer sucker and suction tips;

  2. dental suction equipment;

  3. mucus extractors, including neonatal mucus extractors.

PDF Catalog

PDF Pages PDF Title
4 Foreword
5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
8 Foreword
9 Section sec_1
Section sec_2
Section sec_3
1 Scope
2 Normative references
3 Terms and definitions
10 Section sec_3.1
Section sec_3.2
Section sec_3.3
Section sec_3.4
Section sec_3.5
Section sec_3.6
Section sec_3.7
Section sec_3.8
Section sec_3.9
Section sec_3.10
Section sec_3.11
Section sec_3.12
Section sec_3.13
Section sec_3.14
11 Section sec_3.15
Section sec_3.16
Section sec_3.17
Section sec_4
Section sec_4.1
Section sec_4.1.1
Section sec_4.1.2
Section sec_4.1.3
Section sec_4.1.4
4 General requirements
4.1 Risk management
12 Section sec_4.2
Section sec_4.3
Section sec_4.4
Section sec_5
Section sec_6
Section sec_6.1
Section sec_6.1.1
Section sec_6.1.2
4.2 Usability
4.3 Clinical investigation
4.4 Biophysical or modelling research
5 Cleaning, disinfection and sterilization
6 Design requirements
6.1 Collection container
13 Section sec_6.1.3
Section sec_6.2
Section sec_6.2.1
Section sec_6.2.2
Section sec_6.2.3
Section sec_6.3
6.2 Connections
6.3 Suction tubing
14 Section sec_6.4
Section sec_7
Section sec_7.1
Section sec_7.2
Section sec_7.3
Section sec_7.4
Section sec_7.4.1
6.4 Vacuum level indicators
7 Operational requirements
7.1 Ease of operation
7.2 Dismantling and reassembly
7.3 Mechanical shock
7.4 Stability
15 Section sec_7.4.2
Section sec_7.5
Section sec_7.5.1
Section sec_7.5.2
Section sec_7.6
Section sec_8
Section sec_8.1
Section sec_8.2
7.5 Protection devices
7.6 Immersion in water
8 Physical requirements for field and transport use suction equipment
8.1 (*)Dimensions
8.2 Mass
16 Section sec_9
Section sec_9.1
Section sec_9.2
Section sec_9.3
Section sec_10
Section sec_10.1
Section sec_10.2
Section sec_11
Section sec_11.1
Section sec_11.2
9 Performance requirements for vacuum level and flowrate
9.1 Vacuum level
9.2 Free air flowrate
9.3 Pharyngeal suction
10 (*)Resistance to environment of suction equipment for field and/or transport use
10.1 Operating conditions
10.2 Storage
11 Marking
11.1 Use of symbols
11.2 Equipment
17 Section sec_11.3
Section sec_12
11.3 Equipment or carrying case
12 Information to be supplied by the manufacturer
19 Annex sec_A
Annex sec_A.1
Annex sec_A.2
Annex sec_A.2.1
Annex sec_A.2.2
Annex sec_A.3
Annex A
(normative)

Test methods

20 Table tab_a
Figure fig_A.1
Annex sec_A.4
21 Table tab_b
Figure fig_A.2
Annex sec_A.5
22 Annex sec_A.6
Annex sec_A.7
Annex sec_A.8
Table tab_c
Figure fig_A.3
23 Annex sec_A.9
Annex sec_A.9.1
Annex sec_A.9.1.1
Annex sec_A.9.1.2
Annex sec_A.9.2
Annex sec_A.10
Annex sec_A.10.1
Annex sec_A.10.2
Annex sec_A.10.2.1
Annex sec_A.10.2.2
Annex sec_A.10.2.3
24 Annex sec_A.10.2.4
25 Annex sec_B
Annex sec_B.1
Annex sec_B.2
Annex sec_B.3
Annex sec_B.4
Annex sec_B.5
Annex B
(informative)

Rationale statement

26 Annex sec_C
Table tab_C.1
Annex C
(informative)

Lumen size and its effect on flowrate

27 Annex sec_D
Table tab_d
Figure fig_D.1
Annex D
(informative)

Schematic of suction equipment
Annex D
(informative)

Schematic of suction equipment

28 Reference ref_1
Reference ref_2
Reference ref_3
Reference ref_4
Bibliography
Bibliography

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BS EN ISO 10079-2:2014
$142.49