EN ISO 8871-1 : 2004

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Current The latest, up-to-date edition.

ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLES IN AQUEOUS AUTOCLAVATES

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Published date: 01-09-2004

Publisher: Comite Europeen de Normalisation

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Table of Contents - (Show below) - (Hide below)

Foreword
Introduction
1 Scope
2 Normative references
3 Classification
4 Requirements
5 Sampling
6 Apparatus and reagents
7 Preparation of test solutions
Annex A (normative) Appearance of solution
Annex B (normative) Acidity or alkalinity
Annex C (normative) Absorbance
Annex D (normative) Reducing substances
Annex E (normative) Extractable heavy metals
Annex F (normative) Extractable zinc
Annex G (normative) Extractable ammonia
Annex H (normative) Residue on evaporation
Annex I (normative) Volatile sulfides
Annex J (informative) Conductivity
Annex ZA (normative) Normative references to international
publications with their relevant European
publications
Bibliography

Abstract - (Show below) - (Hide below)

Describes procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous preparations and dry preparations which have to be dissolved before use.

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Committee	CEN/TC 205
Development Note	Supersedes EN ISO 8871 (09/2004)
Document Type	Standard
ISBN
Pages
Published
Publisher	Comite Europeen de Normalisation
Status	Current
Supersedes	EN ISO 8871:1997/A1:1999

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Equivalent Standard(s)	Relationship
PN EN ISO 8871-1 : 2005	Identical
UNI EN ISO 8871-1 : 2006	Identical
ISO 8871-1:2003	Identical
NF EN ISO 8871-1 : 2005	Identical
UNE-EN ISO 8871-1:2005	Identical
NBN EN ISO 8871-1 : 2004	Identical
SN EN ISO 8871-1 : 2005	Identical
NS EN ISO 8871-1 : 1ED 2004	Identical
I.S. EN ISO 8871-1:2004	Identical
DIN EN ISO 8871-1:2004-11	Identical
BS EN ISO 8871-1:2004	Identical
NEN EN ISO 8871-1 : 2004	Identical

Standards Referencing This Book - (Show below) - (Hide below)

ISO 11040-2:2011	Prefilled syringes Part 2: Plunger stoppers for dental local anaesthetic cartridges
ISO 8362-2:2015	Injection containers and accessories — Part 2: Closures for injection vials
ISO 8536-2:2010	Infusion equipment for medical use — Part 2: Closures for infusion bottles
ISO 11040-5:2012	Prefilled syringes — Part 5: Plunger stoppers for injectables
ISO 8871-3:2003	Elastomeric parts for parenterals and for devices for pharmaceutical use Part 3: Determination of released-particle count
EN 28362-2 : 1993	INJECTION CONTAINERS FOR INJECTABLES AND ACCESSORIES - CLOSURES FOR INJECTION VIALS
ISO 8871-2:2003	Elastomeric parts for parenterals and for devices for pharmaceutical use Part 2: Identification and characterization
ISO 8536-6:2016	Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles
ISO 7886-1:2017	Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 8362-5:2016	Injection containers and accessories Part 5: Freeze drying closures for injection vials
ISO 3696:1987	Water for analytical laboratory use — Specification and test methods
ISO 247:2006	Rubber Determination of ash
ISO 48:2010	Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
ISO 2781:2008	Rubber, vulcanized or thermoplastic Determination of density

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