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BS EN ISO 11608-4:2022

BS EN ISO 11608-4:2022

$215.11

Needle-based injection systems for medical use. Requirements and test methods – Needle-based injection systems containing electronics

Published By Publication Date Number of Pages
BSI 2022 72
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This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software (NIS-Es). The needle-based injection system containing electronics can be single use or reusable and can be operated with or without electrical/conductive connections to other devices. The system is intended to deliver medication to a patient by self-administration or by administration by one other operator (e.g. caregiver or health care provider). This document applies to electronic accessories that are intended to be physically connected to a NIS or NIS-E according to the NIS/NIS-E intended use. This document also applies to electronic accessories that are intended to have electrical/conductive connections to a NIS or NIS-E according to the NIS/NIS-E intended use. This document does not specify requirements for software in programmable NIS-E. NOTE       IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 14 addresses software life cycle processes. This document does not specify requirements for cybersecurity.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
11 3 Terms and definitions
19 4 Abbreviated terms
5 General requirements
5.1 Conditions for application of NIS-E
5.2 General design requirements
20 5.3 Risk approach and usability engineering
21 6 General requirements for testing
6.1 Type tests
6.2 Number of samples
26 6.3 Ambient temperature, humidity, atmospheric pressure
7 Identification and marking of NIS-E
8 Protection against electrical hazards
8.1 General
8.2 Humidity preconditioning treatment
27 8.3 Requirements and test methods
8.3.1 General
8.3.2 Applied parts
29 8.3.3 Requirements related to power sources
30 8.3.4 Limitation of current for accessible parts and applied parts
8.4 Separation of parts (Type X and Type Y)
8.4.1 Means of protection (MOP)
31 8.4.2 Separation of patient connection
32 8.4.3 Maximum mains voltage
8.4.4 Working voltage
33 8.5 Patient leakage current and touch current (Type X and Type Y NIS-E)
8.5.1 General
37 8.5.2 Measurement of patient leakage current
41 8.5.3 Measurement of touch current
8.6 Insulation (Type X and Type Y)
8.6.1 General
42 8.6.2 Distance through solid insulation or use of thin sheet material
8.6.3 Dielectric strength
43 8.7 Insulation other than wire insulation
8.7.1 Mechanical strength and resistance to heat
44 8.8 Creepage distances and air clearances (Type X and Type Y NIS-E)
8.8.1 General
8.9 Specific hazardous situations
8.9.1 General
8.9.2 Emissions, deformation of enclosure or exceeding maximum temperature
46 8.9.3 Exceeding leakage current or voltage limits
47 8.9.4 Specific mechanical hazards
8.10 Single fault conditions (Type X and Type Y)
8.10.1 General
8.10.2 Failure of thermostats and temperature limiting devices
8.10.3 Leakage of liquid from batteries
8.10.4 Locking of moving parts
8.10.5 Additional test criteria for motor-operated NIS-E
48 8.10.6 NIS-E intended for used in conjunction with oxygen rich environments
8.10.7 Power supply (Type Y)
49 8.11 Pre-conditioning for the influence of fluid leakage
9 Electromagnetic compatibility (EMC)
9.1 General requirements
9.1.1 Risk approach process for NIS-E
50 9.1.2 Non-medical electrical equipment used with NIS-E
9.1.3 General test conditions
55 9.2 NIS-E identification, marking and documents
9.2.1 Instruction for use in relation to EMC
9.2.2 Documentation of the tests
56 9.3 Electromagnetic emissions requirements for NIS-E
9.3.1 Protection of radio services and other equipment
9.3.2 Protection of the public mains network
57 9.3.3 Emissions requirements summary (Type X and Type Y)
9.4 Electromagnetic immunity requirements for NIS-E
9.4.1 General
59 9.4.2 Operating modes
9.4.3 Non-medical electrical equipment
9.4.4 Immunity test levels
64 9.4.5 Immunity to proximity fields from RF wireless communications equipment
66 9.4.6 Immunity to proximity magnetic fields in the frequency range 9 kHz to 13,56 MHz
10 Protection against mechanical hazards
10.1 General
10.2 Shock
10.3 Vibration
10.3.1 Sinusoidal vibration
10.3.2 Random vibration
67 10.4 Impact of OBDS enclosures
10.5 Push
11 Programmable NIS-E
68 Annex A (informative) Identification of immunity pass/fail criteria
70 Annex B (informative) Rationale for using 240 V for testing some requirements
71 Bibliography

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BS EN ISO 11608-4:2022
$215.11