Back

EVS-EN ISO 8871-1:2004

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates

General information

Valid from 10.12.2004
Base Documents
ISO 8871-1:2003; EN ISO 8871-1:2004
ICS Groups
11.040.20 Transfusion, infusion and injection equipment
Directives or regulations
None

Standard history

Status
Date
Type
Name
10.12.2004
Main
EVS-EN ISO 8871-1:2004
Main
EVS-EN ISO 8871:1999
This part of ISO 8871 defines 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.

Required fields are indicated with *

*
*
*
PDF
19.52 € incl tax
Paper
19.52 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring
English (PDF 303 KB)

Related products

Main

EVS-EN ISO 80369-1:2018

Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2018)
Newest version Valid from 03.12.2018
Main

EVS-EN 60601-2-24:2015

Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
Newest version Valid from 08.06.2015
Main

EVS-EN 60601-2-40:2019

Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
Newest version Valid from 16.01.2019
Main

EVS-EN ISO 8536-4:2020

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019)
Newest version Valid from 17.02.2020

Customers who bought this item also bought

Main

EVS-EN ISO 8871-4:2006

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods
Newest version Valid from 08.08.2006
Main

EVS-EN ISO 8872:2004

Aluminium caps for transfusion, infusion and injection bottles - General requirements and test methods
Withdrawn from 01.12.2022
Main

EVS-EN ISO 8871-2:2004

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization
Withdrawn from 15.06.2020
Main

EVS-EN ISO 8871-3:2004

Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count
Newest version Valid from 12.10.2004

Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English