ISO/TR 19244:2014

Name: ISO/TR 19244:2014 — Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters
SKU: ISO/TR 19244:2014
Price: 25 EUR
Availability: InStock

Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters

Название (английский):

ISO/TR 19244:2014

Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 3
Дата публикации:: 7 августа 2014 г.
Издание:: ISO TR 19244 edition 1 version 1
ICS:: 11.040.01

Тип поставки:

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Язык документа:

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Цена:25 €

Описание (английский):

ISO/TR 19244:2014 outlines the recommended transition plans for all the TC 84 standards: Needle-based Injection systems; Sharps Injury Protection; Sharps Containers, Aerosol Drug Delivery Devices; Needle-free injection systems; Syringes; Needles; Intravascular Catheters and Ports.

Abstract

Overview

Key topics and requirements

Scope: Applies across ISO/TC 84 series, including needle-based injection systems, sharps protection and containers, aerosol drug delivery, needle-free injectors, syringes, needles, intravascular catheters and ports.
Grandfathering (marketed devices):
- Marketed devices that show acceptable post-market safety/performance may remain on the market without meeting the newest standard.
- Conditions: adequate post-market data and an annual updated risk assessment (see ISO 14971).
- If a device undergoes a significant design change, grandfathering should not apply and design verification to the latest standard is recommended.
Non-marketed and new devices:
- Recommended that non-marketed devices be designed to the latest edition.
- New marketed devices should comply with the new standard no later than three years after publication; beyond that, regulators or notified bodies should not accept conformity claims referencing the previous version.
Rationale:
- Transition periods allow time for test method development, validation, documentation updates, and regulatory approval coordination with Notified Bodies and Competent Authorities.

Practical applications

Provides a clear, pragmatic approach for:
- Regulatory affairs teams planning conformity timelines after publication of a revised ISO/TC 84 standard.
- Product development and quality engineers performing design verification and validation.
- Risk managers conducting annual ISO 14971-based assessments to justify grandfathering.
- Notified Bodies and Competent Authorities assessing acceptance of legacy devices and design changes.

Who should use this standard

Medical device manufacturers (R&D, QA/RA)
Regulatory and compliance professionals
Notified Bodies and auditors
Design verification and validation teams
Risk management specialists

Related standards

Key referenced documents include:

ISO 11608 (needle-based injection systems)
ISO 20072 (aerosol drug delivery)
ISO 21649 (needle-free injectors)
ISO 7886 / ISO 8537 / ISO 9626 (syringes and needle components)
ISO 23907 / ISO 23908 (sharps protection)
ISO 10555 / ISO 11070 (intravascular catheters and introducers)
ISO 14971 (risk management)

Keywords: ISO/TR 19244:2014, ISO/TC 84, transition periods, grandfathering, medical devices, administration of medicinal products, catheters, design verification, notified body, risk assessment.

Технические детали

Технический комитет: ISO/TC 84 - Devices for administration of medicinal products and catheters
SKU: ISO/TR 19244:2014

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