ISO 11608-4:2022 医療用の針ベースの注射システム—要件と試験方法— Part 4: 電子機器を含む針ベースの注射システム | ページ 6

3.1

access cover

part of an enclosure or guard providing the possibility of access to electrical equipment parts for the purpose of adjustment, inspection, replacement or repair

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.1]

3.2

accessible part

part of electrical equipment other than an applied part that can be touched by means of the small test finger

Note 1 to entry: See also 8.3.2.

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.2, modified —"test finger" changed to"small test finger", Note 1 to entry added.]

3.3

air clearance

shortest distance in air between two conductive parts

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.5, modified —"shortest path" changed to"shortest distance".]

3.4

applied part

part of electronic needle-based injection system (3.13) that, in normal use (3.28) ,necessarily comes into physical contact with the patient (3.32) for electronic needle-based injection system to perform its function

Note 1 to entry: See also 8.3.2.1 regarding the treatment of parts that do not fall within the definition of applied parts but need to be treated as applied parts as a result of applying the risk approach process.

Note 2 to entry: See also definition of the associated term patient connection (3.33) .

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.8, modified —"ME equipment and ME system" changed to"electronic needle-based injection system", Note 1 to entry deleted, Note 2 changed to Note 1 to entry and amended, Note 3 changed to note 2 to entry and amended.]

3.5

basic insulation

insulation providing basic protection against electric shock

Note 1 to entry: This definition does not include insulation used exclusively for functional purposes.

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.9, modified — Note 1 to entry changed.]

3.6

basic safety

freedom from unacceptable risk directly caused by physical hazards when electronic needle-based injection system (3.13) is used under normal condition and single fault condition (3.42)

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.10, modified —"ME equipment" changed to"electronic needle-based injection system".]

3.7

class II

electrical equipment in which protection against electric shock does not rely on basic insulation only, but in which additional safety precautions such as double insulation or reinforced insulation (3.38) are provided, there being no provision for protective earthing or reliance upon installation conditions

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.14]

3.8

creepage distance

shortest distance along the surface of a solid insulating material between two conductive parts

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.19]

3.9

direct cardiac application

use of applied part (3.4) that can come in direct contact with the patient’s heart

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.22]

3.10

double insulation

insulation comprising both basic insulation (3.5) and supplementary insulation (3.44)

Note 1 to entry: Double insulation provides two means of protection (3.24) .

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.23]

3.11

duty cycle

maximum activation (on) time followed by minimum deactivation (off) time

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.24, modified — “necessary for the safe operation of the ME equipment" deleted.]

3.12

enclosure

exterior surface of electrical equipment or parts thereof

Note 1 to entry: For the purpose of testing to this document, metal foil, with specified dimensions, applied in contact with parts of the exterior surface made of material with low conductivity or made of insulating material is considered a part of the enclosure.

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.26, modified — References to figures in Note 1 to entry deleted.]

3.13

NIS-E

electronic needle-based injection system

injection system containing electronics (with or without software) intended for parenteral administration by injection of medicinal products using a needle or soft cannula and pre-filled or operator-filled, replaceable or non-replaceable containers

3.14

essential performance

performance of a clinical function, other than that related to basic safety (3.6) , where loss or degradation beyond the limits specified by the manufacturer results in an unacceptable risk

Note 1 to entry: Essential performance is most easily understood by considering whether its absence or degradation would result in an unacceptable risk.

Note 2 to entry: ISO 11608-1 instead uses the term"primary function", which at a minimum, includes the dose delivery function, achieved through assessment of dose accuracy.

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.27, modified — Note 2 to entry added.]

3.15

F-type applied part

applied part (3.4) in which the patient (3.32) connections are isolated from other parts of the electronic needle-based injection system (3.13) to such a degree that no current higher than the allowable patient leakage current (3.34) flows if an unintended voltage originating from an external source is connected to the patient (3.32) , and thereby applied between the patient connection (3.33) and earth

Note 1 to entry: Also referred to as: F-type isolated (floating) applied part

Note 2 to entry: F-type applied parts are either type BF (Body Floating) applied parts or type CF (Cardiac Floating) applied parts.

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.29, modified —"ME equipment" changed to"electronic needle-based injection system".]

3.16

functional connection

connection, electrical or otherwise, including those intended to transfer signals, data, power, or substances

Note 1 to entry: Connection to a fixed supply mains (3.45) socket-outlet, whether single or multiple, is not considered to result in a functional connection.

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.33]

3.17

insulation co-ordination

mutual correlation of insulation characteristics of electrical equipment taking into account the expected micro-environment and other influencing stresses

Note 1 to entry: This includes insulation types, creepage distances (3.8) , air clearances (3.3) , distance through insulation, coatings, encapsulation, environmental aspects, etc.

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.43]

3.18

intended use

intended purpose

use for which a product, process or service is intended according to the specifications, instructions and information provided by the manufacturer

Note 1 to entry: The intended medical indication, patient population, part of the body or type of tissue interacted with, user profile, use environment, and operating principle are typical elements of the intended use (3.18) .

Note 2 to entry: Intended use should not be confused with normal use. While both include the concept of use as intended by the manufacturer, intended use focuses on the medical purpose while normal use incorporates not only the medical purpose, but maintenance, transport, etc. as well (IEC 60601 1:2005+AMD1:2012+AMD2:2020, 3.44).

[SOURCE:ISO 14971:2019, 3.6, modified — Note 2 to entry added]

3.19

leakage current

current that is not functional

Note 1 to entry: The following leakage currents are defined: touch current (3.48) and patient leakage current (3.34) .

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.47, modified —"Earth leakage current" deleted from Note 1 to entry.]

3.20

mains part

part of electrical equipment forming a circuit that is intended to be connected to the supply mains (3.45)

Note 1 to entry: The mains part includes all conductive parts that are not separated from the supply mains (3.45) by at least one means of protection (3.24) .

Note 2 to entry: The protective earth conductor is not regarded as a part of the mains part.

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.49, modified — Note 2 to entry changed.]

3.21

maximum mains voltage

voltage used for test purposes related to the voltage of the supply mains (3.45) and connected to certain medical electrical equipment (3.25) parts

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.56, modified — Note to entry deleted.]

3.22

means of operator protection

MOOP

means of protection (3.24) for reducing the risk due to electric shock to persons other than the patient (3.32)

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.58]

3.23

means of patient protection

MOPP

means of protection (3.24) for reducing the risk due to electric shock to the patient (3.32)

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.59]

3.24

means of protection

MOP

means for reducing the risk due to electric shock in accordance with specific requirements

Note 1 to entry: The specific requirements shall be in accordance with IEC 60601-1:2005+AMD1:2012+AMD2:2020.

Note 2 to entry: Means of protection include insulation, air clearances (3.3) , creepage distances (3.8) , impedances, and protective earth connections.

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.60, modified — Note 1 to entry changed to Note 2 to entry, new Note 1 to entry added.]

3.25

medical electrical equipment

electrical equipment having an applied part (3.4) or transferring energy to or from the patient (3.32) or detecting such energy transfer to or from the patient (3.32)

Note 1 to entry: Medical electrical equipment includes those accessories as defined by the manufacturer that are necessary to enable the normal use (3.28) of the medical electrical equipment.

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.63, modified — Notes 2 to 5 to entry deleted.]

3.26

medical electrical system

combination, as specified by its manufacturer, of items or equipment, at least one of which is medical electrical equipment (3.25) intended to be inter-connected by functional connection (3.16) or by use of a multiple socket-outlet

Note 1 to entry: Equipment, when mentioned in this document, should be taken to include medical electrical equipment (3.25) .

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.64, modified —"intended" added to the definition.]

3.27

normal condition

condition in which all means provided for protection against hazards are intact

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.70]

3.28

normal use

operation including routine inspection and adjustments by any operator (3.29) , and stand-by, according to the instructions for use

Note 1 to entry: Normal use should not be confused with intended use (3.18) . While both include the concept of use as intended by the manufacturer, intended use (3.18) focuses on the medical purpose while normal use incorporates not only the medical purpose, but maintenance, transport, etc. as well.

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.71]

3.29

operator

person handling equipment

Note 1 to entry: The operator can be different from the patient (3.32) and can be a caregiver, health care provider or other person.

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.73, modified — Note 1 to entry added.]

3.30

over-current release

protective device that causes a circuit to open, with or without time-delay, when the current in the device exceeds a predetermined value

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.74]

3.31

oxygen rich environment

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.75]

3.32

patient

living being (person or animal) undergoing a medical, surgical, or dental procedure

Note 1 to entry: A patient can be an operator (3.29) .

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.76]

3.33

patient connection

individual point on the applied part (3.4) through which current can flow between the patient (3.32) and the electronic needle-based injection system (3.13) in normal condition (3.27) or single fault condition (3.42)

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.78, modified —"ME equipment" changed to"electronic needle-based injection system".]

3.34

patient leakage current

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.80]

3.35

peak working voltage

highest peak or DC value of a working voltage (3.52) , including repetitive peak impulses generated in the electrical equipment, but not including external transients

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.81]

3.36

potential equalization conductor

conductor other than a protective earth conductor or a neutral conductor, providing a direct connection between electrical equipment and the potential equalization busbar of the electrical installation

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.86, modified — Note to entry deleted.]

3.37

rated

referring to a value assigned by the manufacturer for a specified operating condition

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.97]

3.38

reinforced insulation

single insulation system that provides two means of protection (3.24)

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.99]

3.39

responsible organization

entity accountable for the use and maintenance of an electronic needle-based injection system (3.13)

Note 1 to entry: The accountable entity can be, for example, a hospital, an individual clinician or a layperson. In home use applications, the patient (3.32) , operator (3.29) and responsible organization can be one and the same person.

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.101, modified — Note 2 to entry deleted.]

3.40

secondary circuit

circuit that is separated from the mains part (3.20) by at least one means of protection (3.24) and derives its power from a transformer, converter, or equivalent isolation device, or from an internal electrical power source

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.110, modified — Note to entry deleted.]

3.41

signal input/output part

sip/sop

part of electronic needle-based injection system (3.13) , not being an applied part (3.4) , intended to deliver or receive signals to or from other electrical equipment, for example, for display, recording or data processing

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.115, modified — “ME equipment” changed to “electronic needle-based injection system”, Note to entry deleted.]

3.42

single fault condition

SFC

condition of electronic needle-based injection system (3.13) in which a single means for reducing a risk is defective or a single abnormal condition is present

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.116, modified —"ME equipment" changed to"electronic needle-based injection system".]

3.43

single fault safe

characteristic of electronic needle-based injection system (3.13) or its parts whereby it remains free of unacceptable risk during its expected service life under single fault conditions (3.42)

Note 1 to entry: See 8.10.

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.117, modified —"ME equipment" changed to"electronic needle-based injection system".]

3.44

supplementary insulation

independent insulation applied in addition to basic insulation (3.5) in order to provide protection against electric shock in the event of a failure of basic insulation

Note 1 to entry: Supplementary insulation provides one means of protection (3.24) .

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.119]

3.45

supply mains

source of electrical energy not forming part of electronic needle-based injection system (3.13)

Note 1 to entry: This also includes battery systems and converter systems in ambulances and the like.

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.120, modified —"ME equipment or ME system" changed to"electronic needle-based injection system".]

3.46

thermal cut-out

device that, during an abnormal condition, limits the temperature of electrical equipment or of part of it, by automatically opening the circuit or by reducing the current, and that is so constructed that its setting cannot be altered except by qualified service personnel

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.124]

3.47

thermal stability

condition under which the temperature of an object does not increase by more than 2 °C over a period of 1 h

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.125]

3.48

touch current

leakage current (3.19) flowing from the enclosure (3.12) or from parts thereof, excluding patient connections (3.33) , accessible to any operator (3.29) or patient (3.32) in normal use (3.28) , through an external path other than the protective earth conductor, to earth or to another part of the enclosure (3.12)

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.78, modified — Note to entry deleted.]

3.49

type BF applied part

F-type applied part (3.15) conforming with specific requirements to provide a higher degree of protection against electric shock than that provided by type B applied parts

Note 1 to entry: A type BF applied part is marked with symbol IEC 60417-5333 (see IEC 60601-1:2005+AMD1:2012+AMD2:2020, Table D.1, symbol 20) or, when applicable, with symbol IEC 60417-5334 (see IEC 60601-1:2005+AMD1:2012+AMD2:2020, Table D.1, symbol 26). See also 3.16.

Note 2 to entry: BF type applied parts are not suitable for direct cardiac application (3.9) .

Note 3 to entry: See also 8.3.2.1 regarding the treatment of parts that do not fall within the definition of applied parts (3.4) but shall be considered as applied parts (3.4) as a result of applying the risk approach process.

Note 4 to entry: The specific requirements shall be in accordance with IEC 60601-1:2005+AMD1:2012+AMD2:2020.

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.133, modified —"Risk management process" changed to"risk approach process" in Note 3 to entry, Note 4 to entry added.]

3.50

type CF applied part

F-type applied part (3.15) conforming with specific requirements to provide a higher degree of protection against electric shock than that provided by type BF applied parts (3.49)

Note 1 to entry: A type CF applied part is marked with symbol IEC 60417-5335 (see IEC 60601-1:2005+AMD1:2012+AMD2:2020, Table D.1, symbol 21) or, when applicable, with symbol IEC 60417-5336 (see IEC 60601-1:2005+AMD1:2012+AMD2:2020, Table D.1, symbol 27). See also 3.16.

Note 2 to entry: See also 8.3.2.1 regarding the treatment of parts that do not fall within the definition of applied parts (3.4) but shall be considered as applied parts (3.4) as a result of applying the risk approach process.

Note 3 to entry: The specific requirements shall be in accordance with IEC 60601-1:2005+AMD1:2012+AMD2:2020.

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.134, modified —"Risk management process" changed to"risk approach process" in Note 2 to entry. Note 3 to entry deleted, new Note 3 to entry added.]

3.51

type test

test on representative samples of the equipment with the objective of determining if the electronic needle-based injection system (3.13) , as designed and manufactured, can meet specific requirements

Note 1 to entry: The specific requirements shall be in accordance with IEC 60601-1:2005+AMD1:2012+AMD2:2020.

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.135, modified — Note 1 to entry added]

3.52

working voltage

highest voltage to which the insulation or the component under consideration is, or can be, subjected when the electrical equipment is operating under conditions of normal use (3.28)

Note 1 to entry: Overvoltages that originate outside the equipment are not taken into account.

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.139, modified — Note to entry added.]