SIST EN ISO 14375:2023 PDF

Name: SIST EN ISO 14375:2023 — Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing (ISO 14375:2018)
SKU: SIST EN ISO 14375:2023
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Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing (ISO 14375:2018)

Название (английский):

SIST EN ISO 14375:2023

Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing (ISO 14375:2018)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 22
Дата публикации:: 11 апреля 2023 г.
ICS:: 11.120.01
Технический комитет:: EPO - Packaging - sales and grouped

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Описание (английский):

This document specifies performance requirements and methods of test for non-reclosable packaging that have been designated child-resistant. This document is intended for type approval only (see 3.5) and is not intended for quality assurance purposes.

Abstract

Похожие стандарты

Упомянутые в описании и другие стандарты SIST

Overview

EN ISO 14375:2023 (identical to ISO 14375:2018) defines performance requirements and test methods for child-resistant non-reclosable packaging for pharmaceutical products. Adopted by CEN in March 2023, the standard is intended for type approval of a specific package design (formed from specified materials) and is explicitly not intended for routine quality-assurance testing.

Key topics and requirements

Scope and purpose: Performance requirements and methods of test for non-reclosable packaging designated child‑resistant; used for type approval only.

Definitions: Clear terms such as child-resistant package, non-reclosable child-resistant package, unit dose, substitute product, and type approval.

Performance testing: Two main test categories:

Child test - evaluates whether children (panel testing) can access contents.
Adult test - verifies that adults can use the package as intended.

Test structure: Detailed test process covering:

Principle, samples and sample preparation
Step‑by‑step procedure for child and adult tests
Evaluation criteria and overall test result
Required test reporting

Supporting material:

Annex A - guidance for supervisors during child tests
Annex B - normative test charts
Annex C - discussion on the suitability of sequential procedures used in testing

Practical applications

Packaging designers and manufacturers: Use the standard to design and validate non‑reclosable, child‑resistant pharmaceutical packaging for market entry and type approval.

Pharmaceutical companies: Demonstrate that packaging meets recognized performance tests before launch.

Testing laboratories and conformity assessment bodies: Conduct panel tests and prepare test reports in line with the standard’s procedures and annexes.

Regulators and procurement teams: Reference the standard when assessing packaging safety claims or specifying requirements in tenders and regulatory submissions.

Risk and safety specialists: Use the standard to inform product risk assessments and to ensure packaging is an appropriate safety barrier (recognizing packaging is the last line of defence).

Related standards and bodies

Prepared by ISO/TC 122 (Packaging) and adopted by CEN/TC 261 (Packaging).

EN ISO 14375 complements other packaging and child‑safety guidance; users should consult national regulatory requirements in addition to this standard.

Keywords: EN ISO 14375:2023, ISO 14375, child-resistant packaging, non-reclosable packaging, pharmaceutical packaging, performance requirements, type approval, packaging testing, child test, adult test.

SIST EN ISO 14375:2023 PDF

Abstract

Похожие стандарты

Overview

Key topics and requirements

Practical applications

Related standards and bodies

Технические детали

ISO 14375:2018

Child-resistant non-reclosable packaging for pharmaceutical products — Requirements and testing

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