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BS EN ISO 11608-4:2022 – TC

BS EN ISO 11608-4:2022 – TC

$280.87

Tracked Changes. 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 160
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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
1 30459204
89 A-30387731
90 National foreword
92 European foreword
95 Foreword
96 Introduction
97 1 Scope
2 Normative references
99 3 Terms and definitions
107 4 Abbreviated terms
5 General requirements
5.1 Conditions for application of NIS-E
5.2 General design requirements
108 5.3 Risk approach and usability engineering
109 6 General requirements for testing
6.1 Type tests
6.2 Number of samples
114 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
115 8.3 Requirements and test methods
8.3.1 General
8.3.2 Applied parts
117 8.3.3 Requirements related to power sources
118 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)
119 8.4.2 Separation of patient connection
120 8.4.3 Maximum mains voltage
8.4.4 Working voltage
121 8.5 Patient leakage current and touch current (Type X and Type Y NIS-E)
8.5.1 General
125 8.5.2 Measurement of patient leakage current
129 8.5.3 Measurement of touch current
8.6 Insulation (Type X and Type Y)
8.6.1 General
130 8.6.2 Distance through solid insulation or use of thin sheet material
8.6.3 Dielectric strength
131 8.7 Insulation other than wire insulation
8.7.1 Mechanical strength and resistance to heat
132 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
134 8.9.3 Exceeding leakage current or voltage limits
135 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
136 8.10.6 NIS-E intended for used in conjunction with oxygen rich environments
8.10.7 Power supply (Type Y)
137 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
138 9.1.2 Non-medical electrical equipment used with NIS-E
9.1.3 General test conditions
143 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
144 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
145 9.3.3 Emissions requirements summary (Type X and Type Y)
9.4 Electromagnetic immunity requirements for NIS-E
9.4.1 General
147 9.4.2 Operating modes
9.4.3 Non-medical electrical equipment
9.4.4 Immunity test levels
152 9.4.5 Immunity to proximity fields from RF wireless communications equipment
154 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
155 10.4 Impact of OBDS enclosures
10.5 Push
11 Programmable NIS-E
156 Annex A (informative) Identification of immunity pass/fail criteria
158 Annex B (informative) Rationale for using 240 V for testing some requirements
159 Bibliography

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BS EN ISO 11608-4:2022 - TC
$280.87