1 Scope
2 Normative reference(s)
3 Term(s) and definition(s)
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 ACCOMPANYING DOCUMENTS
6.8.2 Instructions for use
6.101 Test method of legibility
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
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 energy
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 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 Primary electrical (AC or DC) power source -
External
49.101.1 External - No reserve electrical power
source
49.101.2 External - With reserve electrical power
source
49.102 Primary electrical power source - Internal
49.102.1 Internal - No reserve electrical power
source
49.102.2 Internal - With a reserve electrical
power source
49.104 RESERVE ELECTRICAL POWER SOURCE minimum operating
time
49.105 RESERVE ELECTRICAL POWER SOURCE for use outside the
healthcare facility
50 Accuracy of operating data
51 Protection against hazardous output
51.101 MEASUREMENT ACCURACY
51.101.1 General
51.101.2 DRIFT of MEASUREMENT ACCURACY
51.101.3 MEASUREMENT ACCURACY of GAS READINGS for
gas mixtures
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 of
RESPIRATORY GAS MONITORS
101.1 Interfering Gas and vapor effects
101.2 Gas Leakage
101.3 Sample Gas Exhaust Port
101.4 Minimum Sampling Flow
101.5 Contamination of Breathing Systems
201 ALARM SYSTEMS
201.3.2 ALARM PRESETS
201.4.2 Adjustable ALARM LIMITS
201.6 ALARM SIGNAL ANNUNCIATION inactivation states
201.6.3 Indication and access
Tables
Figures
Appendices and Annexes
Annexes
Annex AA Rationale (Informative)
Annex ZA Reference to the Essential Principles (Informative)
Bibliography
Terminology - Index of defined terms