| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 1<\/td>\n | BRITISH STANDARD <\/td>\n<\/tr>\n | ||||||
| 2<\/td>\n | National foreword <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | Foreword Foreword to amendment A1 Contents <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | General 1 R: Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | 3 Terminology and definitions anaesthetic workstation 3.2 R 3.3 R 3.4 R 3.5 R 3.6 R anaesthetic gas scavenging system; AGSS gas mixing system <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | machine gas piping flow control system anaesthetic vapour delivery module; vaporizer pressure regulator emergency anaesthetic equipment medical gas supply system 3.15 R 3.16 R anaesthetic ventilator fresh\ufffdgas outlet; common gas outlet anaesthetic gas <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | anaesthetic gas delivery module enabled condition draw\ufffdover vaporizer permanent connection anaesthetic breathing system circle system circle absorption system circle absorber assembly fresh\ufffdgas inlet respiratory gas\ufffdconducting components transfer system <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | transfer tube receiving system receiving hose disposal system power device AGSS terminal unit maximum extract flow minimum extract flow induced flow spillage clearly legible operator\u2019s position <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 4 General requirements and general requirements for test 4.1 Modifications to EN\ufffd60601\ufffd1:1990, Clause\ufffd3 4.2 Modifications to EN\ufffd60601\ufffd1:1990, Clause\ufffd4 5 Classification 6 Identification, marking and documents <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | Symbols on CO <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 7 Power output <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | Environmental conditions 8 Basic safety categories 9 Removable protection means 10 Environmental conditions 10.101 Pneumatic power supply 11 Not used 12 Not used <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | Protection against electrical shock hazards 13 General 14 Requirements related to classification 15 Limitation of voltage and\/or energy 16 Enclosures and protective covers 17 R: Separation 18 Protective earthing, functional earthing and potential equalization 19 Continuous leakage current and patient auxiliary currents 20 Dielectric strength <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | Protection against mechanical hazards 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 <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | Protection against hazards from unwanted or excessive radiation 29 X\ufffdradiation 30 Alpha, beta, gamma, neutron radiation and other particle radiation 31 Microwave radiation 32 Light radiation (including lasers) 33 Infra\ufffdred radiation 34 Ultra\ufffdviolet radiation 35 Acoustical energy (including ultrasonic) 36 Electromagnetic compatibility 36.101 Electromagnetic compatibility 36.102 Electrostatic discharge <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | R: Protection against hazards of ignition of flammable anaesthetic mixtures 37 Locations and basic requirements 37.101 R: 37.102 R: 37.103 R: 38 Marking, accompanying documents 39 Common requirements for category AP and category APG equipment 40 R: Requirements and tests for category AP equipment, parts and components thereof 41 Requirements and tests for category APG equipment, parts and components thereof <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | Protection against excessive temperatures, and other safety hazards 42 Excessive temperatures 43 R: Fire prevention 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfecti… 44.3 Add 44.7 Add 47.101 In order to minimize the risk of infection to the patient from respiratory gas conducting … 47.102 If a claim is made in the labelling that a device is sterile, the device shall have been s… 47.103 Non\ufffdsterile device packaging systems shall be designed to maintain products which are inte… 45 Pressure vessels and parts subject to pressure 46 Human errors <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 47 Electrostatic charges 48 R: Materials in applied parts in contact with the body of the patient 49 Interruption of the power supply 49.101 Means shall be provided to prevent inadvertent operation of the \u201coff\u201d switch. 49.102 R: Transient interruptions of the power supply shall not cause a safety hazard. <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | Accuracy of operating data and protection against hazardous output 50 Accuracy of operating data 51 Protection against hazardous output 51.101 The particular requirements of the monitoring and alarm modules apply when the anaesthetic… 51.102 Power failure alarm module <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | Emergency anaesthetic equipment configuration for protection against hazardous output <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 51.103 Oxygen supply failure alarm module 51.104 Oxygen monitor and alarm module 51.104.3 Operating condition 51.105 Anaesthetic gas monitor and alarm module <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 51.106 Airway pressure monitoring and alarm module 51.107 Expired volume monitor and alarm module <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 51.108 Anaesthetic breathing system integrity (disconnect) alarm module 51.109 Carbon dioxide monitor and alarm module 51.110 Protection module for cut-off of gases other than oxygen <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 51.111 Anaesthetic gas scavenging system 51.112 Maximum airway pressure protection module 51.113 Adjustable airway pressure limitation protection module 51.114 Alarm signals <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 51.115 Emergency anaesthetic equipment 51.116 R: Operating condition for monitoring and alarm modules <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | Abnormal condition and fault conditions environmental tests 52 Abnormal operation and fault conditions 53 Environmental tests Constructional requirements 54 R: General 55 Enclosures and covers 56 Components and general assembly <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | 57 Mains parts, components and layout Pull forces for testing detachable cords 58 Protective earthing \u2014 terminals and connections 59 Construction and layout <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | Additional requirements specific to anaesthetic workstations 101 Gas supply pressure monitors 101.1 If a gas is supplied at cylinder pressure to the anaesthetic workstation means shall be pro… 101.2 The maximum error of all monitoring devices shall not exceed \u00b1(4 % of the full scale readin… 101.3 Test for compliance with 102 Pressure regulators 103 Machine gas piping 103.1 Machine gas piping shall withstand without rupture a pressure of at least twice its maximum… 103.2 The machine gas piping shall be designed and manufactured to minimize health risks by reduc… 103.3 R: <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | 104 Anaesthetic gas delivery module 104.1 General requirement for anaesthetic gas delivery modules <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | 104.2 Flow control systems Profile of oxygen flow control knob for applications other than anaesthetic vapour delivery syste… <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | 104.3 Flowmeters and flow calibration 104.4 Oxygen flush <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | 104.5 Gas mixing system 105 Anaesthetic vapour delivery module 105.1 General requirements 105.2 Concentration-calibrated anaesthetic vapour delivery modules <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | 106 Respiratory gas conducting components <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | 107 Anaesthetic breathing systems 107.1 General 107.2 Connectors <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | 107.3 Electrical conductivity 107.4 Anaesthetic breathing systems supplied complete or assembled in accordance with the manufac… 107.5 APL valves <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | 107.6 Carbon dioxide absorbers and circle absorber assemblies 107.7 Unidirectional valves <\/td>\n<\/tr>\n | ||||||
| 47<\/td>\n | 107.8 Fresh-gas inlet Screw-threaded fresh-gas connector 107.9 Microbial breathing filters 107.10 Breathing tubes and reservoir bags 107.11 Fresh-gas tubes <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | 108 Heat and moisture exchangers 109 Humidifiers 110 Suction equipment 111 Anaesthetic gas scavenging system (AGSS) 111.1 Patient protection requirements 111.2 R: <\/td>\n<\/tr>\n | ||||||
| 49<\/td>\n | Quick connector for fresh gas <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | Additional measurements for quick connector for fresh gas <\/td>\n<\/tr>\n | ||||||
| 51<\/td>\n | 111.3 Transfer systems 111.4 Receiving systems <\/td>\n<\/tr>\n | ||||||
| 52<\/td>\n | 111.5 Connectors on AGSS systems 112 Anaesthetic ventilator modules <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | Fresh-gas inlet nipple <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | Schematic diagram of typical AGSS connections <\/td>\n<\/tr>\n | ||||||
| 55<\/td>\n | (normative) R: Test of anaesthetic agents for non-flammability (normative) R: Test of anaesthetic agents for non-flammability R: Spark ignition tests Surface temperature ignition tests <\/td>\n<\/tr>\n | ||||||
| 56<\/td>\n | (informative) Rationale (informative) Rationale The purpose of this European Standard is to establish requirements for anaesthetic workstations w… The definition of the applied part in this European Standard is the base for clarification of req… Module Actuator module <\/td>\n<\/tr>\n | ||||||
| 57<\/td>\n | Monitoring module Alarm module Protection module [ [3.6bb)] A fault which is not detected can exist for a long time. Under those circumstances it is… <\/td>\n<\/tr>\n | ||||||
| 62<\/td>\n | Overview of maximum workplace concentration limits Results of ignition tests on anaesthetic agents <\/td>\n<\/tr>\n | ||||||
| 63<\/td>\n | (normative) Applicable requirement clauses for separate modules of an anaesthetic workstation (normative) Applicable requirement clauses for separate modules of an anaesthetic workstation <\/td>\n<\/tr>\n | ||||||
| 64<\/td>\n | (normative) Test method for expired volume monitors (normative) Test method for expired volume monitors Apparatus Procedure Test parameters for expired volume monitors <\/td>\n<\/tr>\n | ||||||
| 65<\/td>\n | Test of measurement devices for expiratory volume <\/td>\n<\/tr>\n | ||||||
| 66<\/td>\n | (normative) Test method for accuracy of anaesthetic vapour delivery modules without applied back … (normative) Test method for accuracy of anaesthetic vapour delivery modules without applied back … General Test the anaesthetic vapour delivery module with the anaesthetic breathing system and, if applica… Use the carrier gas recommended by the manufacturer [see Procedure Fit the anaesthetic vapour delivery module in position on the anaesthetic workstation. Place the anaesthetic vapour delivery module and anaesthetic agent in the test room for at least\ufffd… Set the anaesthetic vapour delivery module to the \u201con\u201d position at the maximum concentration sett… Fill the anaesthetic vapour delivery module with the appropriate anaesthetic agent to approximate… Connect a vapour analyzer to the outlet of the anaesthetic vapour delivery module or, if applicab… For an anaesthetic workstation in which the fresh-gas flow is determined by the anaesthetic venti… Repeat the procedure described in Repeat the sequence of measurements described in Repeat the sequence of measurements given in <\/td>\n<\/tr>\n | ||||||
| 67<\/td>\n | Settings to be used for testing the accuracy of anaesthetic vapour delivery\ufffdmodules (normative) Test method for anaesthetic vapour delivery module accuracy with applied back pressure (normative) Test method for anaesthetic vapour delivery module accuracy with applied back pressure General Test the anaesthetic vapour delivery module with the anaesthetic breathing system and, if applica… Use the carrier gas and gas flow recommended by the manufacturer. [See Procedure Fit the anaesthetic vapour delivery module in position on the anaesthetic workstation. Place the anaesthetic vapour delivery module and anaesthetic agent in the test room for at least\ufffd… Set the anaesthetic vapour delivery module to the \u201con\u201d position at the maximum concentration sett… Fill the anaesthetic vapour delivery module with the appropriate anaesthetic agent to approximate… Connect a vapour analyzer to the outlet of the anaesthetic vapour delivery module or, if applicab… Introduce a pressure fluctuation at the fresh-gas outlet of (2 \u00b1 0,3 kPa. <\/td>\n<\/tr>\n | ||||||
| 68<\/td>\n | Set the anaesthetic vapour delivery module to deliver either 20 % of its maximum concentration se… Repeat the procedure using a fresh-gas flow of (8 \u00b1 0,8) l\/min and a pressure fluctuation at the … For interchangeable anaesthetic vapour delivery modules repeat the procedure using a fresh-gas fl… For interchangeable anaesthetic vapour delivery modules repeat the procedure of For non-interchangeable anaesthetic vapour delivery modules activate the oxygen flush ten times f… (normative) Test methods for anaesthetic breathing systems and breathing attachments (normative) Test methods for anaesthetic breathing systems and breathing attachments General In routine testing, some manufacturers use alternative methods that give comparable results but i… The ambient temperature for the duration of each test shall be between 20 \u00b0C and 25 \u00b0C, except wh… The accuracy of the equipment used to carry out measurements shall be \u00b15 % of the variable to be … Leakage from complete anaesthetic breathing systems Apparatus Procedure <\/td>\n<\/tr>\n | ||||||
| 69<\/td>\n | Expiratory and inspiratory resistance of a complete anaesthetic breathing system Expiratory resistance Inspiratory resistance Resistance to flow of APL valves Apparatus Procedure <\/td>\n<\/tr>\n | ||||||
| 70<\/td>\n | Resistance to flow of APL valves: arrangement for test Leakage from APL valves Apparatus Procedure Expiratory resistance of an absorber assembly Apparatus Procedure <\/td>\n<\/tr>\n | ||||||
| 71<\/td>\n | Inspiratory resistance of an absorber assembly Apparatus Procedure Resistance to flow of unidirectional valves Apparatus Procedure Leakage from APL valves: arrangement for test <\/td>\n<\/tr>\n | ||||||
| 72<\/td>\n | Reverse flow through and dislocation of unidirectional valves Apparatus Procedure Opening pressure of unidirectional valves Apparatus Procedure Leakage from a circle absorber assembly Apparatus Procedure <\/td>\n<\/tr>\n | ||||||
| 73<\/td>\n | Reverse flow through unidirectional valves: arrangement for test <\/td>\n<\/tr>\n | ||||||
| 74<\/td>\n | Arrangement of apparatus to test for opening pressure of unidirectional\ufffdvalves Resistance to flow of unidirectional valves Apparatus Procedure <\/td>\n<\/tr>\n | ||||||
| 75<\/td>\n | Opening pressure of unidirectional valves Apparatus Procedure (normative) Colour coding of anaesthetic vapour delivery modules (normative) Colour coding of anaesthetic vapour delivery modules (normative) Test methods for resistance to flow of the receiving system (normative) Test methods for resistance to flow of the receiving system Apparatus A differential pressure-measuring device A flow-measuring device An adjustable power device Adapter with a type 1 terminal unit socket Procedure Assemble the test apparatus as shown in Connect the receiving system to the adapter. Adjust the power device again to a flow of 25 l\/min. Record the pressure. Calculate the resistance of the receiving system by subtracting the pressure measured in Disconnect the receiving system from the adapter and repeat the test procedure described in <\/td>\n<\/tr>\n | ||||||
| 76<\/td>\n | Test assembly for measuring the resistance to flow of the receiving system (normative) Test method for flow and resistance of AGSS (normative) Test method for flow and resistance of AGSS Apparatus A flow-measuring device A pressure-measuring device Procedure Set up the test apparatus and AGSS as shown in Adjust the air flow to 30 l\/min and record the pressure. Adjust the air flow to 75 l\/min and record the pressure. Connect the inlet of the AGSS or the patient connection port at X-X in Turn on the power device. Adjust the air flow to 30 l\/min, record the pressure and subtract it from the pressure recorded in\ufffd Adjust the air flow to 75 l\/min, record the pressure and subtract it from the pressure recorded in\ufffd Turn off the power device. Repeat <\/td>\n<\/tr>\n | ||||||
| 77<\/td>\n | Test for flow and resistance of AGSS with means of pressure relief integrated\ufffdor attached <\/td>\n<\/tr>\n | ||||||
| 78<\/td>\n | Test for flow and resistance of AGSS with a means of pressure relief integrated in the breathing … (normative) Test method for transfer systems (normative) Test method for transfer systems Apparatus A flow-measuring device A pressure-measuring device Test procedure for a transfer system that has a 30 mm female conical inlet connector Set up the test apparatus and AGSS as shown in Adjust a flow of 30 l\/min of air and record the pressure. Connect the AGSS at X-X in If applicable, apply force to the transfer tube as shown in Adjust the air flow to 30 l\/min and allow steady state conditions to be achieved. Record the pressure and subtract the pressure measured in Disconnect the AGSS at X-X in Repeat the test procedure described from <\/td>\n<\/tr>\n | ||||||
| 79<\/td>\n | Test procedure for a transfer system that has a proprietary inlet connector Set up the test apparatus and AGSS as shown in Adjust a flow of 30 l\/min of air and record the pressure. Connect the AGSS at X-X in If applicable, apply force to the transfer tube as shown in Adjust the air flow to 30 l\/min and allow steady state conditions to be achieved. Record the pressure and subtract the pressure measured in Disconnect the AGSS at X-X in Repeat the test procedure described from Method of test for means of pressure relief integrated in or attached to\ufffdan\ufffdAGSS <\/td>\n<\/tr>\n | ||||||
| 80<\/td>\n | Occlusion of AGSS transfer hose: arrangement for test <\/td>\n<\/tr>\n | ||||||
| 81<\/td>\n | Method of test for means of pressure relief integrated in the anaesthetic breathing system (normative) Test method for induced flow and sub-atmospheric pressure of AGSS (normative) Test method for induced flow and sub-atmospheric pressure of AGSS Induced flow Apparatus Procedure Sub-atmospheric pressure Apparatus Procedure <\/td>\n<\/tr>\n | ||||||
| 82<\/td>\n | Example of flow-metering device for induced flow <\/td>\n<\/tr>\n | ||||||
| 83<\/td>\n | (normative) Test method for spillage from the transfer and receiving systems (normative) Test method for spillage from the transfer and receiving systems Apparatus Calibration procedure Test flow pattern Test procedure Calculation of results <\/td>\n<\/tr>\n | ||||||
| 84<\/td>\n | Spillage from the transfer and receiving systems of AGSS arrangement for test Test flow pattern for AGSS <\/td>\n<\/tr>\n | ||||||
| 85<\/td>\n | (informative) Guidelines for situations in which AGSS are used with flammable anaesthetic gases a… (informative) Guidelines for situations in which AGSS are used with flammable anaesthetic gases a… The \u201czone of risk\u201d associated with flammable anaesthetic gases and volatile agents has been recog… If the AGSS is marked as being suitable for use with flammable anaesthetics, it can be used for s… If the AGSS is installed within a boom or pendant fitting, for example with other medical gas ter… There should be electrical continuity between the receiving system and the anaesthetic workstation. (normative) Ergonomics and symbols (normative) Ergonomics and symbols General requirements and conditions Visual indicators and their associated markings and warnings integral to the anaesthetic workstat… Place the test operator in the operator\u2019s position at a distance of 500 mm from the anaesthetic w… Visual indicators integral to the anaesthetic workstation, e.g. for breathing circuit integrity, … R: <\/td>\n<\/tr>\n | ||||||
| 86<\/td>\n | High and medium priority indicators shall be clearly legible when tested in accordance with R: (normative) Method of test for draw-over vaporizers used with emergency anaesthetic equipment (normative) Method of test for draw-over vaporizers used with emergency anaesthetic equipment General Test the emergency anaesthetic equipment with the draw-over vaporizer, anaesthetic breathing syst… Use the carrier gas recommended by the manufacturer, [see Procedure Connect the draw-over vaporizer to the non-rebreathing system which is required to prevent revers… Place the emergency anaesthetic equipment and anaesthetic agent in the test room for at least 3 h… Set the draw-over vaporizer to the \u201con\u201d position at the maximum concentration setting. Operate th… Fill the draw-over vaporizer with the appropriate anaesthetic agent to approximately halfway betw… Either: <\/td>\n<\/tr>\n | ||||||
| 87<\/td>\n | Repeat the procedure described in For the sequence of measurements described in (informative) Bibliography (informative) Bibliography <\/td>\n<\/tr>\n | ||||||
| 88<\/td>\n | (normative) Special national conditions (normative) Special national conditions <\/td>\n<\/tr>\n | ||||||
| 89<\/td>\n | (informative) Clauses of this European Standard addressing essential requirements or other provis… (informative) Clauses of this European Standard addressing essential requirements or other provis… Correspondence between this European Standard and EU Directives <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Anaesthetic workstations and their modules. Particular requirements<\/b><\/p>\n |