{"id":278179,"date":"2024-10-19T18:44:42","date_gmt":"2024-10-19T18:44:42","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-18-30383266-dc\/"},"modified":"2024-10-25T15:16:53","modified_gmt":"2024-10-25T15:16:53","slug":"bsi-18-30383266-dc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-18-30383266-dc\/","title":{"rendered":"BSI 18\/30383266 DC"},"content":{"rendered":"

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
12<\/td>\nForeword <\/td>\n<\/tr>\n
14<\/td>\nIntroduction <\/td>\n<\/tr>\n
18<\/td>\n201.1 Scope, object and related standards
201.1. 1 * Scope <\/td>\n<\/tr>\n
19<\/td>\n201.1. 2 Object
201.1. 3 Collateral standards
201.1. 4 *Particular standards <\/td>\n<\/tr>\n
20<\/td>\n201.2 Normative references <\/td>\n<\/tr>\n
23<\/td>\n201.3 Terms and definitions
active anaesthetic gas scavenging system <\/td>\n<\/tr>\n
24<\/td>\nanaesthetic gas
anaesthetic gas delivery system piping <\/td>\n<\/tr>\n
25<\/td>\nanaesthetic ventilator
anaesthetic workstation
breathing tube
circle absorber assembly
danger zone <\/td>\n<\/tr>\n
26<\/td>\ndisposal hose
disposal system
exhaust port
exhaust valve
fresh gas <\/td>\n<\/tr>\n
27<\/td>\nfresh-gas inlet
fresh-gas outlet
high-flow transfer and receiving system
transfer and receiving system that connects to a high-flow-rate disposal system
low-flow transfer and receiving system
transfer and receiving system that connects to a low-flow-rate disposal system <\/td>\n<\/tr>\n
28<\/td>\nmonitoring equipment
patient connection port
power device
power supply
protection device
receiving system
spillage
transfer system <\/td>\n<\/tr>\n
29<\/td>\ny-piece
201.4 General requirements
201.4. 3 * Essential performance
201.4. 10 Power supply
201.4. 10.101* Requirements for pneumatic power input <\/td>\n<\/tr>\n
30<\/td>\n201.5 General requirements for testing ME equipment
201.5.101 Additional general requirements for testing of anaesthetic workstations and anaesthetic workstation components including accessories
201.5.101.1 Test conditions <\/td>\n<\/tr>\n
31<\/td>\n201.5.101.2 Test equipment
201.5.101.3 * Gas flow rate and leakage specifications
Correct all test measurements to STPD or BTPS, as appropriate.
201.6 Classification of ME equipment or ME systems
210.7 ME equipment identification, marking and documents
201.7.2 Marking on the outside of ME equipment or ME equipment parts
201.7.2.3 * Consult accompanying documents <\/td>\n<\/tr>\n
32<\/td>\n201.7.2.101 Marking with year of manufacture or use-by date
Check compliance by visual inspection.
201.7.2.102 Operator-accessible gas-specific inlet and outlet
201.7.2.103 * Operator-accessible gas power supply outlet
201.7.2.104 Devices Components, parts and accessories containing phthalates <\/td>\n<\/tr>\n
33<\/td>\n201.7.2.105 Cylinder and pipeline pressure indicators
201.7.4.2 * Control devices
201.7.4.3 * Unit of measure
201.7.9.1 General <\/td>\n<\/tr>\n
34<\/td>\n201.7.9.2.1 General
201.7.9.2.2 * Warnings and safety notices
201.7.9.2.8 * Start-up procedure
201.7.9.2.101 Additional requirements for the instructions for use ((previously under 201.7.9.2.14)) <\/td>\n<\/tr>\n
35<\/td>\n201.7.9.3 Technical description
201.7.9.3.1 General
201.7.9.3.101 Components <\/td>\n<\/tr>\n
36<\/td>\n201.7.9.3.102 Anaesthetic workstations intended to be mounted to a wall or ceiling pendant
201.8 Protection against electrical hazards from ME equipment
201.8.11.3 Power supply cords
201.8.11.3.101 * Additional requirements for power supply cords <\/td>\n<\/tr>\n
37<\/td>\n201.9 Protection against mechanical hazards of ME equipment and ME systems
201.9.2 Mechanical hazards associated with moving parts
201.9.2.1 General
201.9.2.101 Maintenance points
201.9.2.102 * Lighting
201.9.2.103 * Integrated seating <\/td>\n<\/tr>\n
38<\/td>\n201.9.2.104 * Arrangement of control positions
201.9.4 Instability hazards
201.9.4.2.4.3 Movement over a threshold
201.10 Protection against unwanted and excessive radiation hazards <\/td>\n<\/tr>\n
39<\/td>\n201.11 Protection against excessive temperatures and other hazards
201.11.6.3 Spillage on ME equipment and ME systems
Replacement:
Check compliance by the following test:
201.11.6.8 Compatibility with substances used with the ME equipment
201.11.8 Interruption of the power supply\/supply mains to ME equipment
201.11.8.101 * General requirements <\/td>\n<\/tr>\n
40<\/td>\n201.11.8.102 * Alarm condition for power supply failure
201.11.8.103 * Internal electrical power source <\/td>\n<\/tr>\n
41<\/td>\n201.11.101 Packaging systems for components intended to be sterilized
201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.12.4 Protection against hazardous output
201.12.4.101 * Accidental adjustment of operating controls <\/td>\n<\/tr>\n
42<\/td>\n201.12.4.102 * Additional requirements for anaesthetic workstations
201.12.4.103 Respiratory gas monitoring equipment
201.12.4.103.1 Carbon dioxide monitoring equipment <\/td>\n<\/tr>\n
43<\/td>\n201.12.4.103.2 Oxygen monitoring equipment
201.12.4.103.3 Anaesthetic agent monitoring equipment
201.12.4.104 Exhaled volume monitoring equipment
201.12.4.104.1 * Accuracy <\/td>\n<\/tr>\n
44<\/td>\n201.12.4.104.2 Alarm conditions
201.12.4.105 * Anaesthetic breathing system integrity alarm condition
201.12.4.106 * Anaesthetic breathing system continuing-positive-pressure alarm condition <\/td>\n<\/tr>\n
45<\/td>\n201.12.4.107 Anaesthetic gas delivery system oxygen supply and delivery
201.12.4.107.1 Oxygen supply failure alarm system
201.12.4.107.2 * Oxygen supply failure protection device <\/td>\n<\/tr>\n
46<\/td>\n201.12.4.107.3 * Hypoxic mixture delivery selection protection device
201.12.4.108 * Protection device for the workplace environment
201.12.4.109 Airway pressure monitoring equipment <\/td>\n<\/tr>\n
47<\/td>\n201.13 Hazardous situations and fault conditions
201.13.101 * Simultaneous failure
201.14 Programmable electrical medical systems (PEMS)
201.14.6.1 * Identification of known and foreseeable hazards <\/td>\n<\/tr>\n
48<\/td>\n201.14.101 Software life cycle processes
201.15 Construction of ME equipment
201.15.3.5 Rough handling test
Amend as follows:
201.15.101 Operator-detachable, flow-direction-sensitive components parts and accessories
201.16 ME systems
201.16.9.2.1 Multiple socket-outlet
Addition:
Add the following list item: <\/td>\n<\/tr>\n
49<\/td>\n201.16.101 Additional requirements for signal input\/output part
201.16.101.1 General
201.16.101.2 Connection to electronic health record
201.16.101.3 Connection to distributed alarm system
201.16.101.4 * Connection for remote control
201.17 Electromagnetic compatibility of ME equipment and ME systems <\/td>\n<\/tr>\n
50<\/td>\n201.101 Additional requirements for anaesthetic gas delivery systems
201.101.1 Identification and documents
201.101.1.1 Instructions for use <\/td>\n<\/tr>\n
51<\/td>\n201.101.1.2 Technical description
201.101.2 * Interruption of the electrical power supply
201.101.3 Protection against cross-contamination of volatile anaesthetic agents
201.101.4 Medical gas supply
201.101.4.1 Cylinder supplies
201.101.4.1.1 Inlet connector <\/td>\n<\/tr>\n
52<\/td>\n201.101.4.1.2 Inlet filtration
201.101.4.1.3 Pressure regulators
201.101.4.1.4 * Reserve oxygen supply
201.101.4.2 Pipeline supplies
201.101.4.2.1 Inlet connector
201.101.4.2.2 Inlet filtration
201.101.4.2.3 Reverse flow and cross-flow protection device <\/td>\n<\/tr>\n
53<\/td>\n201.101.4.3 Pressure or content monitoring equipment
201.101.5 Anaesthetic gas delivery system leakage
201.101.5.1 Leakage prior to the flow rate adjustment control element
201.101.5.2 Leakage after the flow rate adjustment control element <\/td>\n<\/tr>\n
54<\/td>\n201.101.6 Gas flow rate metering
201.101.6.1 Graduations and accuracy
201.101.6.2 Flow rate adjustment control <\/td>\n<\/tr>\n
55<\/td>\n201.101.6.3 * Carbon dioxide flow rate adjustment control
201.101.7 Gas mixers
201.101.8 * Oxygen flush <\/td>\n<\/tr>\n
56<\/td>\n201.101.9 * Fresh-gas outlet
201.102 Additional requirements for an anaesthetic breathing system
201.102.1 Identification, marking and documents
201.102.1.1 Marking
201.102.1.1.1 Non-metallic components parts
201.102.1.1.2 Bag\/ventilator control
201.102.1.1.3 Absorbent bypass <\/td>\n<\/tr>\n
57<\/td>\n201.102.1.1.4 Inspiratory and expiratory ports of a circle absorber assembly
201.102.1.2 Instructions for use <\/td>\n<\/tr>\n
59<\/td>\n201.102.2 Pressure limitation protection device
201.102.2.1 * Maximum limited pressure protection device
201.102.2.2 * Adjustable pressure limitation protection device
201.102.3 Packaging of parts of anaesthetic breathing systems component packaging
201.102.4 * Electrical conductivity <\/td>\n<\/tr>\n
60<\/td>\n201.102.5 Connection ports
201.102.5.1 Patient connection port
201.102.5.2 Exhaust port connector
201.102.5.3 * Reservoir bag connection port <\/td>\n<\/tr>\n
62<\/td>\n201.102.5.4 Anaesthetic ventilator port connector
201.102.5.5 Anaesthetic breathing system component port connector
201.102.5.6 * Inspiratory and expiratory port connectors of a circle absorber assembly
201.102.5.7 Other port connectors <\/td>\n<\/tr>\n
63<\/td>\n201.102.6 * Leakage
201.102.7 * Inspiratory and expiratory pressure\/flow rate characteristics
201.102.8 Anaesthetic breathing system components parts and accessories
201.102.8.1 * Y-piece
201.102.8.2 * Exhaust valve <\/td>\n<\/tr>\n
64<\/td>\n201.102.9 Circle absorber assemblies
201.102.9.1 * Constructional requirements
201.102.9.2 * Absorbent bypass mechanism <\/td>\n<\/tr>\n
65<\/td>\n201.102.9.3 Resistance to flow rate
201.102.10 Inspiratory and expiratory valves
201.102.10.1 * Constructional requirements
201.102.10.2 Opening pressure <\/td>\n<\/tr>\n
66<\/td>\n201.102.10.3 Pressure flow-rate characteristics
201.102.10.4 * Reverse flow rate and dislocation <\/td>\n<\/tr>\n
67<\/td>\n201.102.11 * Fresh-gas inlet
201.102.12 Ventilation modes
201.103 Additional requirements for an anaesthetic gas scavenging system
201.103.1 Identification, marking and documents
201.103.1.1 Marking
201.103.1.2 Instructions for use
201.103.2 Pressure relief protection device <\/td>\n<\/tr>\n
68<\/td>\n201.103.3 Basic requirements
201.103.3.1 Normal condition
201.103.3.1.1 Anaesthetic gas scavenging system inlet pressure
201.103.3.1.2 Induced flow rate
201.103.3.1.3 Flow resistance
201.103.3.1.4 Spillage to atmosphere <\/td>\n<\/tr>\n
69<\/td>\n201.103.3.1.5 Leakage
201.103.3.2 Single fault condition
201.103.3.2.1 Pressure
201.103.3.2.2 Induced flow rate
201.103.3.2.3 Subatmospheric pressure at the input of the receiving system
201.103.4 Connectors
201.103.4.1 Hose connectors <\/td>\n<\/tr>\n
70<\/td>\n201.103.4.2 Connections between parts of transfer systems and receiving systems
201.103.4.3 Connections to diverting respiratory gas monitors
201.103.5 Transfer system
201.103.5.1 Inlet <\/td>\n<\/tr>\n
71<\/td>\n201.103.5.2 Outlet
201.103.6 Receiving system
201.103.6.1 Inlet connectors
201.103.6.2 * Outlet connectors
201.103.6.3 Hoses
201.103.6.4 Particle filter <\/td>\n<\/tr>\n
72<\/td>\n201.103.7 Transfer systems and receiving systems with integral power device
201.103.8 Visual indicator
201.104 Additional requirements for an anaesthetic vapour delivery system
201.104.1 Identification, marking and documents
201.104.1.1 * Marking <\/td>\n<\/tr>\n
73<\/td>\n201.104.1.2 Instructions for use
201.104.2 Delivered vapour concentration
201.104.2.1 Controls <\/td>\n<\/tr>\n
74<\/td>\n201.104.2.2 * Accuracy <\/td>\n<\/tr>\n
75<\/td>\n201.104.3 * Vapour concentration during and after oxygen flush <\/td>\n<\/tr>\n
76<\/td>\n201.104.4 Connectors
201.104.5 Cross-contamination
201.104.6 Anaesthetic vapour delivery system filling <\/td>\n<\/tr>\n
77<\/td>\n201.104.7 Packaging of anaesthetic vapour delivery system parts and accessories
201.105 Additional requirements for an anaesthetic ventilator
201.105.1 Instructions for use <\/td>\n<\/tr>\n
78<\/td>\n201.105.2 Pressure limitation protection device
201.105.2.1 Maximum limited pressure protection device
201.105.2.2 * Adjustable pressure limitation protection device <\/td>\n<\/tr>\n
79<\/td>\n201.105.3 Activation of automatic ventilation
201.105.4 Breathing system connection port
201.105.5 Interruption of the electrical or pneumatic power supply
201.105.6 Exhaust port connector <\/td>\n<\/tr>\n
80<\/td>\n201.105.7 * Timed ventilatory pause
201.105.7.1 Expiratory pause <\/td>\n<\/tr>\n
81<\/td>\n201.105.7.2 Inspiratory pause
The following applies to an inspiratory pause function.
201.105.8 * Subatmospheric pressure <\/td>\n<\/tr>\n
83<\/td>\nKey <\/td>\n<\/tr>\n
84<\/td>\n201.106 Display of pressure-volume loops
201.107 Clinical evaluation
202 Electromagnetic disturbances \u2014 Requirements and tests
203 General requirements for radiation protection in diagnostic X-ray equipment
206 Usability <\/td>\n<\/tr>\n
85<\/td>\n208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
208.5.2.2 * Technical description <\/td>\n<\/tr>\n
86<\/td>\n208.6.8.3 * Global indefinite alarm signal inactivation states
208.6.8.4 * Termination of inactivation of alarm signals
208.6.12 * Alarm system logging
209 Requirements for environmentally conscious design
210 Process requirements for the development of physiologic closed-loop controllers
211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment <\/td>\n<\/tr>\n
87<\/td>\n212 Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment <\/td>\n<\/tr>\n
88<\/td>\nAnnex C (informative) Guide to marking and labelling requirements for ME equipment and ME systems or their parts
201.C.1 Marking on the outside of ME equipment and ME systems or their parts <\/td>\n<\/tr>\n
90<\/td>\n201.C.3 Marking of controls and instruments <\/td>\n<\/tr>\n
91<\/td>\n201.C.4 Accompanying documents, general <\/td>\n<\/tr>\n
98<\/td>\n201.C.4 Accompanying documents, technical description <\/td>\n<\/tr>\n
99<\/td>\nAnnex D (informative) Symbols on marking <\/td>\n<\/tr>\n
102<\/td>\nAnnex AA (informative) Particular guidance and rationale <\/td>\n<\/tr>\n
118<\/td>\nPausing mechanical ventilation is necessary for certain clinical procedures. <\/td>\n<\/tr>\n
120<\/td>\nAnnex BB (normative) Test for flammability of anaesthetic agent
BB.1 General
BB.2 Spark ignition tests
BB.3 Surface temperature ignition tests <\/td>\n<\/tr>\n
121<\/td>\nAnnex CC (informative) Data interface requirements For consideration during CD stage <\/td>\n<\/tr>\n
122<\/td>\nAnnex DD <\/td>\n<\/tr>\n
126<\/td>\nBibliography <\/td>\n<\/tr>\n
128<\/td>\nAnhang ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93\/42\/EEC [OJ L 169] aimed to be covered <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

BS EN ISO 80601-2-13. Medical electrical equipment – Part 2-13. Particular requirements for basic safety and essential performance of an anaesthetic workstation<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2018<\/td>\n139<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":278185,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2641],"product_tag":[],"class_list":{"0":"post-278179","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-10","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/278179","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/278185"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=278179"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=278179"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=278179"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}