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//SIST EN ISO 11608-1:2022/A1:2026

SIST EN ISO 11608-1:2022/A1:2026

Name: SIST EN ISO 11608-1:2022/A1:2026 — Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems - Amendment 1 (ISO 11608-1:2022/Amd1:2026)
SKU: SIST EN ISO 11608-1:2022/A1:2026
Price: 16200 RUB
Availability: InStock

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems - Amendment 1 (ISO 11608-1:2022/Amd1:2026)

Название (английский):

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems - Amendment 1 (ISO 11608-1:2022/Amd1:2026)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 9
Дата публикации:: 21 мая 2026 г.
Издание:: ISO 11608-1:2022/Amd1:2026
ICS:: 11.040.25

Тип поставки:

Full version16 200 ₽Read online 24h1 200 ₽Read online 72h1 800 ₽

Язык документа:

ruen

Срок поставки:2 раб. дн. (перевод)

Цена:16 200 ₽

Abstract

Overview

SIST EN ISO 11608-1:2022/A1:2026 is an international amendment standard specifying requirements and test methods for needle-based injection systems (NIS) used in medical settings. This amendment aligns with ISO 11608-1:2022/Amd1:2026 and has been harmonized across European standards, enhancing consistency and patient safety in the design, performance, and testing of injection pens and similar devices.

Key Topics

Primary Functions Definition The standard clarifies that all essential performance functions required for safety and effectiveness, particularly dose delivery and dose accuracy, must be identified early in the design phase and stringently verified during testing.
Test Methods and Equipment Detailed requirements establish that primary functions should be tested using suitably calibrated and precise systems. Gauge R&R (Repeatability and Reproducibility) for test apparatus is specified to ensure credible measurement results, with clear limits for acceptable variability.
Lifecycle and Functional Stability The amendment mandates that needle-based injection systems retain their functionality not only throughout their anticipated in-use period but also after exposure to stress conditions (such as transport simulation or environmental challenges) and at the end of their shelf-life.
Inspection and Testing Sequences Comprehensive guidance is provided for performing inspections and functional tests after subjecting devices to stressed or normal conditions, simulating real-world handling and use, and ensuring safety before patient administration.
Risk Assessment Process Enhanced procedures outline how to distinguish between primary functions (associated with unacceptable harm severity) and essential performance (considering both harm probability and severity), framing a robust approach to risk management in medical device development.

Applications

This standard is applied across the lifecycle of needle-based injection systems, with practical benefits including:

Medical Device Development: Guiding design teams in identifying critical system functions and validating device performance under both normal and stressed conditions.
Regulatory Compliance: Supporting conformity with European and international regulations for non-active medical devices, facilitating market access and patient safety.
Quality Assurance: Ensuring that NIS products consistently meet defined requirements for functional stability, dose accuracy, and usability throughout their labeled shelf-life and in-use duration.
Testing Laboratories: Providing detailed instructions for configuring test environments, calibrating equipment, and performing comprehensive product verification.
Risk Management: Enabling a structured assessment of design and operational risks to mitigate potential harm associated with NIS failures or inaccuracies.

Related Standards

ISO 11608 Series: This amendment is part of the broader ISO 11608 family, which addresses various aspects of needle-based injection systems, including component compatibility and electronic controls.
EN ISO 11608-1:2022: The base standard specifying requirements and testing for NIS, with which this amendment must be used.
ISO 14971: Standard for the application of risk management to medical devices, often referenced when identifying and mitigating risks highlighted in ISO 11608-1.
CEN/TC 205 Standards: Additional European standards for non-active medical devices, supporting harmonization and safe use across clinical settings.

By integrating SIST EN ISO 11608-1:2022/A1:2026 into product development and compliance processes, stakeholders contribute to higher safety, reliability, and clinical effectiveness of medical injection systems used in patient care.

Key SEO terms: needle-based injection systems, medical injection pens standard, ISO 11608-1, requirements for NIS, test methods for medical devices, functional stability, dose accuracy, non-active medical devices, regulatory compliance, risk management.

Технические детали

Технический комитет: VAZ - Healthcare
SKU: SIST EN ISO 11608-1:2022/A1:2026

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Каталог

ISO 11608-1:2022

Действующий

Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injecti…

Overview ISO 11608-1:2022 - Needle-based injection systems for medical use (Part 1) specifies requirements and test methods for needle-based injection systems (NISs) designed for single-patient, bolu…

69 · PDF

124 200 ₽

BS EN ISO 11608-2:2012

Отменён

Needle-based injection systems for medical use. Requirements and test methods - Needles

1 Scope This part of ISO 11608 specifies requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems ( NISs ) that fulfil the specifications of ISO…

PDF

6 000 ₽