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.<\/p>\n
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| 2<\/td>\n | National foreword <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | European foreword <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 4 Abbreviated terms 5 General requirements 5.1 Conditions for application of NIS-E 5.2 General design requirements <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 5.3 Risk approach and usability engineering <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 6 General requirements for testing 6.1 Type tests 6.2 Number of samples <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 8.3 Requirements and test methods 8.3.1 General 8.3.2 Applied parts <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 8.3.3 Requirements related to power sources <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 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) <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 8.4.2 Separation of patient connection <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 8.4.3 Maximum mains voltage 8.4.4 Working voltage <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 8.5 Patient leakage current and touch current (Type X and Type Y NIS-E) 8.5.1 General <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | 8.5.2 Measurement of patient leakage current <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | 8.5.3 Measurement of touch current 8.6 Insulation (Type X and Type Y) 8.6.1 General <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | 8.6.2 Distance through solid insulation or use of thin sheet material 8.6.3 Dielectric strength <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | 8.7 Insulation other than wire insulation 8.7.1 Mechanical strength and resistance to heat <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | 8.9.3 Exceeding leakage current or voltage limits <\/td>\n<\/tr>\n | ||||||
| 47<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | 8.10.6 NIS-E intended for used in conjunction with oxygen rich environments 8.10.7 Power supply (Type Y) <\/td>\n<\/tr>\n | ||||||
| 49<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | 9.1.2 Non-medical electrical equipment used with NIS-E 9.1.3 General test conditions <\/td>\n<\/tr>\n | ||||||
| 55<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 56<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 57<\/td>\n | 9.3.3 Emissions requirements summary (Type X and Type Y) 9.4 Electromagnetic immunity requirements for NIS-E 9.4.1 General <\/td>\n<\/tr>\n | ||||||
| 59<\/td>\n | 9.4.2 Operating modes 9.4.3 Non-medical electrical equipment 9.4.4 Immunity test levels <\/td>\n<\/tr>\n | ||||||
| 64<\/td>\n | 9.4.5 Immunity to proximity fields from RF wireless communications equipment <\/td>\n<\/tr>\n | ||||||
| 66<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 67<\/td>\n | 10.4 Impact of OBDS enclosures 10.5 Push 11 Programmable NIS-E <\/td>\n<\/tr>\n | ||||||
| 68<\/td>\n | Annex A (informative) Identification of immunity pass\/fail criteria <\/td>\n<\/tr>\n | ||||||
| 70<\/td>\n | Annex B (informative) Rationale for using 240 V for testing some requirements <\/td>\n<\/tr>\n | ||||||
| 71<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Needle-based injection systems for medical use. Requirements and test methods – Needle-based injection systems containing electronics<\/b><\/p>\n |