EN ISO 21647:2009

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
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 specifically related to
    respiratory gas monitors
102 Alarm systems
103 Appendices of IEC 60601-1:1988
Annex AA (informative) - Rationale
Annex BB (informative) - Reference to the Essential
         Principles
Annex CC (informative) - Environmental aspects
Annex DD (informative) - Vocabulary - Index of defined terms
Bibliography
Annex ZA (Informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC

ISO 21647:2004 specifies particular requirements for the basic safety and essential performance of respiratory gas monitors (RGM) (as defined in 3.15) intended for continuous operation for use with humans. It supplements the requirements of IEC 60601-1:1988.ISO 21647:2004 specifies requirements for anaesthetic gas monitoring, carbon dioxide monitoring and oxygen monitoring.ISO 21647:2004 is not applicable to monitors intended for use with flammable anaesthetic agents.The requirements of ISO 21647:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.Environmental aspects are addressed in Annex CC. Additional aspects of environmental impact are addressed in ISO 14971.