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NEN EN ISO 8835-4 : 2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES

Superseded date

19-12-2012

Published date

12-01-2013

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements and general requirements for tests
5 Classification
6 Identification, marking and documents
7 Power input
8 Basic safety categories
9 Removable protective means
10 Environmental conditions
11 Not used
12 Not used
13 General
14 Requirements related to classification
15 Limitation of voltage and/or energy
16 Enclosures and protective covers
17 Separation
18 Protective earthing, functional earthing and potential
    equalization
19 Continuous leakage currents and patient auxiliary currents
20 Dielectric strength
21 Mechanical strength
22 Moving parts
23 Surfaces, corners and edges
24 Stability in normal use
25 Expelled parts
26 Vibration and noise
27 Pneumatic and hydraulic power
28 Suspended masses
29 X-radiation
30 Alpha, beta, gamma, neutron radiation and other particle
    radiation
31 Microwave radiation
32 Light radiation (including lasers)
33 Infra-red radiation
34 Ultraviolet radiation
35 Acoustical energy (including ultrasonics)
36 Electromagnetic compatibility
37 Locations and basic requirements
38 Marking and accompanying documents
39 Common requirements for category AP and category APG
    equipment
40 Requirements and tests for category AP equipment, parts
    and components thereof
41 Requirements and tests for category APG equipment, parts
    and components thereof
42 Excessive temperatures
43 Fire prevention
44 Overflow, spillage, leakage, humidity, ingress of liquids,
    cleaning, sterilization, disinfection and compatibility
45 Pressure vessels and parts subject to pressure
46 Human errors
47 Electrostatic charges
48 Biocompatibility
49 Interruption of the power supply
50 Accuracy of operating data
51 Protection against hazardous output
52 Abnormal operation and fault conditions
53 Environmental tests
54 General
55 Enclosures and covers
56 Components and general assembly
57 Mains parts, components and layout
58 Protective earthing - Terminals and connections
59 Construction and layout
101 Additional requirements for AVDDs
102 Appendices of IEC 60601-1:1988
Annex AA (informative) Rationale
Annex BB (informative) Recommended colours for colour coding
                       of anaesthetic vapour delivery devices
Annex CC (normative) Test for flammability of anaesthetic agents
Bibliography

Defines particular requirements for the essential performance of anaesthetic vapour delivery devices (AVDDs). It also provides specific requirements for AVDDs, which are supplementary to the applicable general requirements in IEC 60601-2-13.

DocumentType
Standard
PublisherName
Netherlands Standards
Status
Superseded

Standards Relationship
BS EN ISO 8835-4:2009 Identical
EN ISO 8835-4:2009 Identical
DIN EN ISO 8835-4:2009-07 Identical
UNE-EN ISO 8835-4:2009 Identical
I.S. EN ISO 8835-4:2009 Identical
ISO 8835-4:2004 Identical
UNI EN ISO 8835-4 : 2009 Identical

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