UNI EN ISO 21647 : 2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements and general requirements for tests
    4.101 Other test methods
    4.102 Acceptance criteria
5 Classification
6 Identification, marking and documents
    6.1 Marking on the outside of equipment or equipment
          parts
    6.3 Markings of controls and instruments
    6.8.2 Instructions for use
    6.101 Test for legibility
7 Power input
8 Basic safety categories
9 Removable protective means
10 Environmental conditions
    10.1 Transport and storage
    10.2.2 Power supply
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
    21.101 Shock and vibration
    21.102 Shock and vibration for transport
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
    43.101 RGM used in conjunction with oxidants
44 Overflow, spillage, leakage, humidity, ingress of
    liquids, cleaning, sterilization, disinfection and
    compatibility
    44.3 Spillage
    44.7 Cleaning, sterilization and disinfection
    44.8 Compatibility with substances used with the
         equipment
45 Pressure vessels and parts subject to pressure
46 Human errors
47 Electrostatic charges
48 Biocompatibility
49 Interruption of the power supply
    49.101 Power failure alarm conditions
    49.102 Settings and data storage following short
           interruptions or automatic switchover
    49.103 Reserve electrical power source
    49.104 Reserve electrical power source for use outside
           the healthcare facility
50 Accuracy of operating data
51 Protection against hazardous output
    51.101 Measurement accuracy
    51.102 Total system response time
    51.103 Indication of gas readings units of measure
    51.104 Indication of operating mode
52 Abnormal operation and fault conditions
53 Environmental tests
54 General
55 Enclosures and covers
56 Components and general assembly
    56.7 Batteries
57 Mains parts, components and layout
    57.3 Power supply cords
58 Protective earthing - terminals and connections
59 Construction and layout
101 Additional requirements specifically related to
    respiratory gas monitors
    101.1 Interfering gas and vapour effects
    101.2 Gas leakage
    101.3 Exhaust port connector for diverting respiratory
          gas monitor
    101.4 Minimum sampling flowrate
    101.5 Contamination of breathing systems
102 Alarm systems
    201.1.2 Alarm condition priority
    201.2 Disclosures for intelligent alarm system
    201.5 Alarm presets
    201.5.1 General requirements
    201.6.2 Adjustable alarm limit
    201.8 Alarm signal inactivation states
    201.8.3 Indication and access
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
Annex ZA (Informative) Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC
Bibliography

Describes particular requirements for the basic safety and essential performance of respiratory gas monitors (RGM) intended for continuous operation for use with humans. Also covers requirements for anaesthetic gas monitoring, carbon dioxide monitoring, and oxygen monitoring.