ISO 11608-4:2022 PDF

Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics

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Title (English):

ISO 11608-4:2022

Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 63
Publication date:: April 7, 2022
Edition:: ISO IS 11608 edition 2 version 1
ICS:: 11.040.25

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Description (English):

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.

Technical details

Technical committee: ISO/TC 84 - Devices for administration of medicinal products and catheters
SKU: ISO 11608-4:2022

Abstract

Overview

ISO 11608-4:2022 specifies requirements and test methods for needle-based injection systems containing electronics (NIS‑E). It covers single‑use and reusable NIS‑Es, with or without software, and includes electronic accessories that are intended to be physically or electrically connected to the system. The standard applies to devices used for self‑administration or administration by a caregiver or healthcare provider and includes on‑body delivery systems (OBDSs) and electromechanical pen injectors. It is the second edition and integrates relevant requirements from the IEC 60601 series for hand‑held medical injectors.

Key topics and technical requirements

Scope and definitions: Clarifies types of NIS‑E, applied parts, and accessory interfaces.
General design and risk management: Emphasizes a risk‑based approach and usability engineering tied to intended use.
Electrical safety: Requirements and test methods for protection against electrical hazards, insulation, patient leakage current, touch current, and separation of parts (Type X / Type Y classifications).
Electromagnetic compatibility (EMC): Emissions and immunity requirements, identification of operating modes, test documentation, and immunity to proximity fields from RF wireless equipment.
Mechanical hazards: Tests for shock, vibration, impact and on‑body enclosure performance.
Programmable NIS‑E: Specific considerations for programmable devices (note: the document does not itself specify software life‑cycle requirements).
Testing and preconditioning: Type tests, sample sizes, ambient conditions, humidity and fluid‑leakage preconditioning, and tests addressing single‑fault conditions.
Identification and marking: Labelling, instructions for use (including EMC-related instructions) and test record documentation.
Annexes and references: Informative annexes (e.g., rationale for using 240 V in some tests) and harmonization with IEC/ISO normative references.

Important exclusions: ISO 11608‑4:2022 does not specify software life‑cycle requirements for programmable software (see IEC 60601‑1 Clause 14) and does not set cybersecurity requirements.

Practical applications - who uses this standard

Medical device manufacturers and design engineers developing electronic pen injectors, OBDS or other NIS‑Es
Product safety and validation teams performing type and conformity testing
Regulatory and quality affairs personnel preparing technical files for market approval or CE marking
Test laboratories and notified bodies assessing electrical safety, EMC and mechanical robustness
Procurement and accessory suppliers ensuring compatibility with NIS‑E interfaces

Related standards (if applicable)

ISO 11608 series (other parts covering dose setting, delivery performance, etc.)
IEC 60601 series (electrical safety and software life‑cycle considerations referenced)
National and regional medical device EMC and safety guidance

Keywords: ISO 11608‑4:2022, needle‑based injection systems, NIS‑E, electronic injectors, medical device standards, EMC testing, electrical safety, on‑body delivery systems, programmable injectors.

Related standards

Standards mentioned in the description

Abstract

Overview

Key topics and technical requirements

Scope and definitions: Clarifies types of NIS‑E, applied parts, and accessory interfaces.
General design and risk management: Emphasizes a risk‑based approach and usability engineering tied to intended use.
Electrical safety: Requirements and test methods for protection against electrical hazards, insulation, patient leakage current, touch current, and separation of parts (Type X / Type Y classifications).
Electromagnetic compatibility (EMC): Emissions and immunity requirements, identification of operating modes, test documentation, and immunity to proximity fields from RF wireless equipment.
Mechanical hazards: Tests for shock, vibration, impact and on‑body enclosure performance.
Programmable NIS‑E: Specific considerations for programmable devices (note: the document does not itself specify software life‑cycle requirements).
Testing and preconditioning: Type tests, sample sizes, ambient conditions, humidity and fluid‑leakage preconditioning, and tests addressing single‑fault conditions.
Identification and marking: Labelling, instructions for use (including EMC-related instructions) and test record documentation.
Annexes and references: Informative annexes (e.g., rationale for using 240 V in some tests) and harmonization with IEC/ISO normative references.

Practical applications - who uses this standard

Medical device manufacturers and design engineers developing electronic pen injectors, OBDS or other NIS‑Es
Product safety and validation teams performing type and conformity testing
Regulatory and quality affairs personnel preparing technical files for market approval or CE marking
Test laboratories and notified bodies assessing electrical safety, EMC and mechanical robustness
Procurement and accessory suppliers ensuring compatibility with NIS‑E interfaces

Related standards (if applicable)

ISO 11608 series (other parts covering dose setting, delivery performance, etc.)
IEC 60601 series (electrical safety and software life‑cycle considerations referenced)
National and regional medical device EMC and safety guidance

ISO 11608-4:2022 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Practical applications - who uses this standard

Related standards (if applicable)

Related standards

Abstract

Overview

Key topics and technical requirements

Practical applications - who uses this standard

Related standards (if applicable)

Related standards

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