SIST EN ISO 8871-4:2006 PDF

Name: SIST EN ISO 8871-4:2006 — Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006)
SKU: SIST EN ISO 8871-4:2006
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Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006)

Название (английский):

SIST EN ISO 8871-4:2006

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 15
Дата публикации:: 1 сентября 2006 г.
ICS:: 11.040.20
Технический комитет:: VAZ - Healthcare

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Описание (английский):

ISO 8871-4:2006 specifies biological requirements for elastomeric parts for parenterals and for devices for pharmaceutical use. It also specifies the test methods, i.e. it offers the extraction procedures for elastomeric parts, and it makes reference to relevant biological test instructions in Pharmacopoeias and standards.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 8871-4:2006 - "Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods" (ISO 8871-4:2006) specifies biological safety requirements and validated test methods for elastomeric components used in primary pharmaceutical packaging and drug‑delivery devices. The standard defines extraction procedures, biological tests and reporting conventions to assess extractable endotoxins, bioburden, and toxicity of elastomeric parts such as closures, stoppers, needle shields and other rubber items in contact with parenteral products.

Key topics and technical requirements

Scope and purpose: Biological evaluation of elastomeric parts intended for parenterals and pharmaceutical devices; guidance for selection and interpretation of tests based on material chemistry and exposure conditions.

Extractable bacterial endotoxins: Annex A provides an extraction method (example: ~100 cm² of parts agitated in endotoxin‑free water, with detection by LAL per USP/Ph.Eur.). Results expressed as EU/cm² or EU/ml. Limits are to be agreed between supplier and user; test validation is required.

Bioburden: Bioburden (cfu/cm² or cfu per part) is monitored; methods should be validated (ISO 11737-1 referenced). Acceptable limits are contractual between supplier and user.

Toxicity testing strategy: A tiered approach - start with in vitro cytotoxicity (Annex B) using serum‑supplemented culture medium and specified extraction ratio; if in vitro fails, proceed to in vivo intracutaneous (Annex C) and systemic toxicity (Annex D) testing. Assessment criteria reference USP chapters <87> and <88> and ISO 10993-5.

Test method validation and documentation: All methods and extraction procedures must be validated and reported, including sample/medium ratios, temperatures and extraction times.

Practical applications

Ensures biological safety of elastomeric primary packaging for injectables (vials, prefilled syringes, stoppers, seals).

Supports supplier qualification, incoming inspection and batch release testing for pharmaceutical manufacturers.

Provides testing protocols for contract testing laboratories and QA/QC teams to demonstrate compliance with regulatory expectations for parenteral contact materials.

Facilitates supplier–user agreements on endotoxin and bioburden limits and on appropriate biological test batteries for specific applications (e.g., freeze‑drying stoppers, small cavities).

Related standards and references

ISO 8871 (Parts 1–5) - related parts cover extractables, identification, particles and functional testing

ISO 10993‑5 - in vitro cytotoxicity

ISO 11737‑1 - microbiological methods for bioburden

USP chapters <85>, <87>, <88> and Ph.Eur. 2.6.14 - bacterial endotoxins and biological reactivity tests

Keywords: elastomeric parts, parenterals, biological requirements, test methods, extractable endotoxins, bioburden, cytotoxicity, LAL, USP, ISO 8871-4.

SIST EN ISO 8871-4:2006 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications

Who should use this standard

Related standards and references

Технические детали

ISO 8871-4:2006

Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4: Biological requirements an…

ISO 11737-1:2018/Amd 1:2021

Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of mi…

ISO 10993-5:2009

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

ISO 8871-3:2003/Amd 1:2018

Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 3: Determination of released-…