BS 5724-2.30(1993) : 1993
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR CAPNOMETERS FOR USE WITH HUMANS
Hardcopy , PDF
15-05-1997
English
01-01-1993
Committees responsible
National foreword
Introduction
Section 1. General
1.1 Scope
1.2 Normative references
1.3 Definitions
1.4 General requirements
1.5 General requirements for tests
1.6 Classification
1.7 Identification, marking and documents
1.8 Power input
Section 2. Environmental conditions
2.1 Basic safety categories
2.2 Removable protective means
2.3 Environmental conditions
2.4 Special measures with respect to safety
2.5 Single fault condition
Section 3. Protection against electric shock hazards
3.1 General
3.2 Requirements related to classification
3.3 Limitation of voltage and/or energy
3.4 Enclosures and protective covers
3.5 Separation
3.6 Protective earthing, functional earthing and
potential equalization
3.7 Continuous leakage current and patient auxiliary
currents
3.8 Dielectric strength
Section 4. Protection against mechanical hazards
4.1 Mechanical strength
4.2 Moving parts
4.3 Surfaces, corners and edges
4.4 Stability in normal use
4.5 Expelled parts
4.6 Vibration and noise
4.7 Pneumatic and hydraulic power
4.8 Suspended masses
Section 5. Protection against hazards from unwanted or
excessive radiation
5.1 X-radiation
5.2 Alpha, beta, gamma, neutron radiation and other
particle radiation
5.3 Microwave radiation
5.4 Light radiation (including lasers)
5.5 Infra-red radiation
5.6 Ultraviolet radiation
5.7 Acoustical energy (including ultra-sonics)
5.8 Electromagnetic compatibility
Section 6. Protection against hazards of ignition of
flammable anaesthetic mixtures
6.1 Locations and basic requirements
6.2 Marking and accompanying documents
6.3 Common requirements for category AP and category
APG equipment
6.4 Requirements and tests for category AP equipment,
parts and components
6.5 Requirements and tests for category APG equipment,
and parts and components
Section 7. Protection against excessive temperatures and
other safety hazards
7.1 Excessive temperatures
7.2 Fire prevention
7.3 Overflow, spillage, leakage, humidity, ingress of
liquids, cleaning, sterilization and disinfection
7.4 Pressure vessels and parts subject to pressure
7.5 Human errors
7.6 Electrostatic charges
7.7 Materials in applied parts in contact with body of
patient
7.8 Interruption of power supply
Section 8. Accuracy of operating data and protection
against hazardous output
8.1 Accuracy of operating data
Section 9. Abnormal operation and fault conditions:
environmental tests
9.1 Abnormal operation and fault conditions
9.2 Environmental tests
Section 10. Constructional requirements
10.1 General
10.2 Enclosures and covers
10.3 Components and general assembly
10.4 Main parts, components and layout
10.5 Protective earthing - Terminal and connections
10.6 Construction and layout
Section 11. Additional requirements specific to
capnometers
Annex
L (informative) Rationale
National annex
NA (informative) Clarification of clause 60.2.2 'Test
gases'
Specifies requirements for the safety of capnometers. Applies to capnometers used with adults, children and neonates. Not applicable to devices meant for use as transcutaneous monitors. Includes the following sections: Environmental Conditions; Protection against Electric Shock Hazards; Protection against Mechanical Hazards; Protection against Hazards from Unwanted or Excessive Radiation; Protection against Hazards of Ignition of Flammable Anaesthetic Mixtures.
Committee |
HCC/46
|
DevelopmentNote |
DRAFT FOR COMMENT 89/55068 DC
|
DocumentType |
Standard
|
Pages |
32
|
PublisherName |
British Standards Institution
|
Status |
Superseded
|
SupersededBy |
Standards | Relationship |
ISO 9918:1993 | Identical |
ISO 3744:2010 | Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane |
ISO 9703-1:1992 | Anaesthesia and respiratory care alarm signals Part 1: Visual alarm signals |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ISO 5356-1:2015 | Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
ISO 5356-2:2012 | Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
IEC 60651:1979+AMD1:1993+AMD2:2000 CSV | Sound level meters |
IEC 60801-2:1991 | Electromagnetic compatibility for industrial-process measurement and control equipment - Part 2: Electrostatic discharge requirements |
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