CSA Z18778 : 2008 : R2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS
Hardcopy , PDF
10-12-2020
English, French
01-01-2018
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 Infrared 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
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
Annex AA (informative) - Rationale
Annex BB (informative) - Environmental aspects
Annex CC (informative) - Index of defined terms
Bibliography
Specifies requirements for the safety and essential performance of monitors used to detect apparent life-threatening events) in sleeping or resting children under three years of age.
DocumentType |
Standard
|
Pages |
45
|
ProductNote |
Reconfirmed EN
|
PublisherName |
Canadian Standards Association
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
ISO 15001:2010 | Anaesthetic and respiratory equipment Compatibility with oxygen |
IEC 60068-2-64:2008 | Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance |
EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
CSA C22.2 No. 60529 : 2016 | DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) |
EN 71-1:2014 | Safety of toys - Part 1: Mechanical and physical properties |
NFPA 53M : 1990 | FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES |
ISO 9919:2005 | Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
ISO 4135:2001 | Anaesthetic and respiratory equipment Vocabulary |
EN 980:2008 | Symbols for use in the labelling of medical devices |
EN 60601-1-8:2007/A11:2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012) |
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