SIST EN ISO 8872:2023 PDF

Name: SIST EN ISO 8872:2023 — Aluminium caps and aluminium/plastic caps for infusion bottles and injection vials - General requirements and test methods (ISO 8872:2022)
SKU: SIST EN ISO 8872:2023
Price: 73.76 EUR
Availability: InStock

Aluminium caps and aluminium/plastic caps for infusion bottles and injection vials - General requirements and test methods (ISO 8872:2022)

Название (английский):

SIST EN ISO 8872:2023

Aluminium caps and aluminium/plastic caps for infusion bottles and injection vials - General requirements and test methods (ISO 8872:2022)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 21
Дата публикации:: 17 января 2023 г.
ICS:: 11.040.20
Технический комитет:: VAZ - Healthcare

Тип поставки:

Full version315 €Read online 24h10 €Read online 72h15 €

Язык документа:

ruen

Срок поставки:4 раб. дн. (перевод)

Цена:315 €

Описание (английский):

This document specifies general requirements and test methods for aluminium caps and aluminium/plastic caps intended for use on infusion bottles and/or injection vials.

Abstract

Overview

Key Topics

Scope and definitions: applicability to caps intended for infusion and injection containers; terms such as coating and cap components.
Material and mechanical requirements: mechanical characteristics for aluminium and plastic components (tensile and related properties).
Chemical composition and contamination: guidelines to ensure materials are appropriate for medical use and free from harmful contamination.
Dimensions and defects: dimensional tolerances, earing and other acceptable defect criteria for manufacturing quality control.
Functional requirements: opening and tear-off forces, joining integrity of aluminium/plastic combinations, and performance after sterilization.
Test methods: standardized test procedures for mechanical testing, chemical analysis, dimensional verification, earing measurement and post-sterilization tests.
Packaging and marking: requirements for safe delivery, traceability and labelling.
Informative and normative annexes: type drawings and detailed opening/tear-off force methods.

Applications

Ensuring consistent quality and safety of caps used on pharmaceutical infusion bottles and injection vials.
Providing test procedures for quality control, incoming inspection and production verification.
Supporting design and material selection for manufacturers of aluminium caps and aluminium/plastic caps.
Serving as a reference in regulatory submissions, conformity assessment and supplier agreements.

Who should use this standard

Manufacturers of aluminium and aluminium/plastic caps
Medical device and pharmaceutical packaging engineers
Quality assurance and regulatory compliance teams
Testing laboratories performing mechanical and sterility-related tests
Procurement and specification writers for hospitals and pharmaceutical companies

Related standards

EN ISO 8872:2022 references and aligns with other standards, including:

ISO 8362 series (caps for injection vials)
ISO 8536 series (infusion equipment caps)
ISO 6892-1 (tensile testing of metallic materials)
ISO 7500-1 (calibration of testing machines)

Using EN ISO 8872:2022 helps suppliers and healthcare manufacturers meet unified requirements for cap performance, safety and testability across European and international markets.

Технические детали

SKU: SIST EN ISO 8872:2023

Главная

Каталог

ISO 8872:2022

Действующий

Aluminium caps and aluminium/plastic caps for infusion bottles and injection vials — General requirements and…

Overview ISO 8872:2022 specifies general requirements and test methods for aluminium caps and aluminium/plastic caps used on infusion bottles and injection vials. This third edition (2022) integrates…

13 · PDF

25 €

ISO 10985:1999

Отменён

Caps made of aluminium-plastics combinations for infusion bottles and injection vials — Requirements and test…

4 · PDF

123 €

SIST EN ISO 8362-2:2024

Действующий

Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2024)

Overview EN ISO 8362-2:2024 - "Injection containers and accessories - Part 2: Closures for injection vials" specifies shape, dimensions, materials, performance requirements and labelling for closures…

14 · PDF

60 €

ISO 8536-15:2022/Amd 1:2023

Действующий

Infusion equipment for medical use — Part 15: Light-protective infusion sets for single use — Amendment 1

Overview ISO 8536-15:2022/Amd 1:2023 is an important amendment to the international standard for infusion equipment used in medical settings. Specifically, it addresses light-protective infusion sets…

1 · PDF

21 €

SIST EN ISO 6892-1:2020

Действующий

Metallic materials - Tensile testing - Part 1: Method of test at room temperature (ISO 6892-1:2019)

Overview SIST EN ISO 6892-1:2020 (ISO 6892-1:2019) specifies the standardized method for tensile testing of metallic materials at room temperature. The document defines the test procedure, required t…

87 · PDF

135 €

SIST EN ISO 7500-1:2018

Действующий

Metallic materials - Calibration and verification of static uniaxial testing machines - Part 1: Tension/compr…

Overview EN ISO 7500-1:2018 - "Metallic materials - Calibration and verification of static uniaxial testing machines - Part 1: Tension/compression testing machines - Calibration and verification of t…

25 · PDF

74 €

SIST EN ISO 8872:2023 PDF

Abstract

Overview

Похожие стандарты

Key Topics

Applications

Who should use this standard

Related standards

Технические детали

ISO 8872:2022

Aluminium caps and aluminium/plastic caps for infusion bottles and injection vials — General requirements and…

ISO 10985:1999

Caps made of aluminium-plastics combinations for infusion bottles and injection vials — Requirements and test…

SIST EN ISO 8362-2:2024

Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2024)

ISO 8536-15:2022/Amd 1:2023

Infusion equipment for medical use — Part 15: Light-protective infusion sets for single use — Amendment 1

SIST EN ISO 6892-1:2020

Metallic materials - Tensile testing - Part 1: Method of test at room temperature (ISO 6892-1:2019)

SIST EN ISO 7500-1:2018

Metallic materials - Calibration and verification of static uniaxial testing machines - Part 1: Tension/compr…