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BS EN ISO 8185:1998, BS 5724-2.24:1998 Humidifiers for medical use. General requirements for humidification systems, 2003
- BRITISH STANDARD [Go to Page]
- National foreword
- Contents [Go to Page]
- Foreword
- General
- Introduction [Go to Page]
- 1.1 Scope
- 1.2 Normative references
- 1.3 Definitions [Go to Page]
- 1.3.101 accessible surface temperature
- 1.3.102 delivery tube
- 1.3.103 delivered gas temperature
- 1.3.104 heated delivery tube controller
- 1.3.105 humidification chamber
- 1.3.106 humidification system
- 1.3.107 humidifier
- 1.3.108 humidifier outlet
- 1.3.109 humidifier output
- 1.3.110 liquid container
- 1.3.111 liquid reservoir
- 1.3.112 maximum operating pressure
- 1.3.113 measured gas temperature
- 1.3.114 operating volume
- 1.3.115 patient connection port
- 1.3.116 relative humidity
- 1.3.117 set temperature
- 1.3.118 thermal hazard
- 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 requirements
- 2.2 Removable protective means
- 2.3 Environmental conditions
- 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 currents and patient auxiliary currents
- 3.8 Dielectric strength
- Section 4 Protection against mechanical hazards
- 4.1 Mechanical strength
- 4.2 Moving parts
- 4.3 Surface, 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 5Protection against hazards from unwanted or excessive radiation
- 5.1 The requirements given in Clauses�
- 5.2 Electromagnetic compatibility
- Section 6 Protection against hazards of ignition of flammable anaesthetic mixtures
- 6.1 Locations and basic requirements
- 6.2 Marking, 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 thereof
- 6.5 Requirements and tests for category APG equipment, parts and components thereof
- 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 error
- 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
- 8.2 Protection against hazardo us output
- 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 Enclosure and covers
- 10.3 Components and general assembly
- 10.4 Mains parts, components and layout
- 10.5 Protective earthing — Terminals and connections
- 10.6 Construction and layout
- Section 11 Additional requirements specific to humidifiers
- 11.1 Humidifier output
- 11.2 Maximum pressure drop
- 11.3 Liquid container [Go to Page]
- 11.3.1 Filling
- 11.3.2 Liquid level
- 11.3.3 Filling cap
- 11.4 Noise measurement [Go to Page]
- 11.4.1 If humidifiers are intended to be used in association with incubators, the humidifier shall not c...
- 11.4.2 The steady-state noise generated by humidifiers shall not exceed�50�dBA at any point�1�m from the...
- 11.5 Temperature sensors and temperature sensor ports [Go to Page]
- 11.5.1 Temperature sensors shall meet the gauging requirements in
- 11.5.2 When the temperature sensors and mating ports are engaged according to the manufacturers recommen...
- 11.5.3 Temperature sensors that do not comply with the dimensional requirements of
- 11.6 Humidifier leakage [Go to Page]
- 11.6.1 The rate of gas leakage from the humidifier shall not exceed�10�ml/min. when tested as described in�
- 11.6.2 Occlude all ports except the humidifier inlet. Apply static pressure of�(8,0�±�0,5)�kPa to the in...
- Annex M (normative) Test of anaesthetic agents for non-flammability [Go to Page]
- (normative) Test of anaesthetic agents for non-flammability
- M.1 General
- M.2 Spark ignition tests
- M.3 Surface temperature ignition tests
- Annex N (normative) Temperature display accuracy [Go to Page]
- (normative) Temperature display accuracy
- N.1 Test preparation
- N.2 Test procedure [Go to Page]
- Figure N.1
- N.2.1 Temperatures shall be sampled at least every�2�s.
- N.2.2 Operate the humidification system over the manufacturers’ recommended flowrate range.
- N.2.3 Set the minimum set temperature and confirm that the measured gas temperature equals the arithmet...
- N.2.4 Quickly change the set temperature from the minimum to the maximum setting.
- N.2.5 Confirm that the measured gas temperature equals the arithmetic mean�±4�°°C of the two standard t...
- N.2.6 Confirm that the measured gas temperature equals the arithmetic mean�±2�°°C of the two standard t...
- Annex O (informative) Specific enthalpy calculations [Go to Page]
- (informative) Specific enthalpy calculations
- Annex P (normative) Humidifier output calculations [Go to Page]
- (normative) Humidifier output calculations
- P.1 General
- P.2 Test preparation
- P.3 Test procedure
- Annex Q (normative) Temperature sensors and mating ports [Go to Page]
- (normative) Temperature sensors and mating ports
- Q.1 Dimensional requirements for temperature sensors [Go to Page]
- Q.1.1 The axial length of the taper of temperature sensors shall be at least�10,5�mm.
- Q.1.2 When the temperature sensor is engaged with the ring gauge shown in
- Q.2 Test method for security of engagement of the temperature sensors to mating ports [Go to Page]
- Q.2.1 Condition temperature sensors and mating ports at�(41�±�2)�°°C and�(95�±�5)�% RH for at least�1�h.
- Q.2.2 Engage the temperature sensor with the mating port in accordance with the manufacturer’s instruct...
- Q.2.3 Condition the engaged components, without activation of any disengagement mechanism, for at least...
- Q.2.4 Apply an axial separation force of�(25 ±�2,5) N for�10�s at a rate not exceeding�20�N·s� [Go to Page]
- Figure Q.1
- Q.3 Test method for leakage from temperature sensors engaged in mating ports [Go to Page]
- Q.3.1 Apply a static pressure of�(8,0�±�0,5)�kPa to the temperature sensor and mating port assembly.
- Q.3.2 Measure or calculate the leakage to atmosphere from the sensor and mating port assembly.
- Annex R (normative) Standard temperature sensor [Go to Page]
- (normative) Standard temperature sensor
- Annex S (informative) Rationale statement [Go to Page]
- (informative) Rationale statement [Go to Page]
- Figure S.1 Heat transfer, relative to�37�°°C, saturated
- Annex T (informative) Bibliography [Go to Page]
- (informative) Bibliography
- Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provis... [Go to Page]
- (informative) Clauses of this European Standard addressing essential requirements or other provis... [Go to Page]
- Table ZA.1 Correspondence between this European Standard and EU Directives
- Annex ZB (normative) Normative references to international publications with their relevant European publi... [Go to Page]
- (normative) Normative references to international publications with their relevant European publi... [Go to Page]
