Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016)

ISO 8871-5:2016 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.
NOTE Functional testing with spikes is specified in ISO 8536‑2 and in ISO 8536‑6.

Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung - Teil 5: Funktionelle Anforderungen und Prüfung (ISO 8871-5:2016)

Dieser Teil von ISO 8871 legt Anforderungen und Prüfverfahren hinsichtlich funktioneller Merkmale von Verschlüssen aus Elastomeren fest, die für Injektionsflaschen verwendet und mit einer Injektionskanüle durchstochen werden.
ANMERKUNG   Funktionelle Prüfungen unter Verwendung von Dornen sind in ISO 8536-2 und ISO 8536-6 festgelegt.

Éléments en élastomère pour administration parentérale et dispositifs à usage pharmaceutique - Partie 5: Exigences fonctionnelles et essais (ISO 8871-5:2016)

ISO 8871:2016 spécifie les exigences et les méthodes d'essai portant sur les propriétés fonctionnelles des fermetures en élastomère, utilisées avec des flacons et percées à l'aide d'une aiguille pour injection.
NOTE Les essais fonctionnels à l'aide d'un trocart sont spécifiés dans l'ISO 8536‑2 et dans l'ISO 8536‑6.

Deli iz elastomera za parenteralne farmacevtske oblike - 5. del: Funkcionalne zahteve in preskušanje (ISO 8871-5:2016)

Ta del standarda ISO 8871 določa zahteve in preskusne metode za funkcionalne parametre zapiral iz elastomera, ki se uporabljajo skupaj z vialami, ko jih predre injekcijska igla.
OPOMBA: Preskušanje delovanja s konicami je določeno v standardih ISO 8536-2 in ISO 8536-6.

General Information

Status
Published
Publication Date
22-Nov-2016
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
23-Nov-2016
Completion Date
23-Nov-2016

RELATIONS

Buy Standard

Standard
EN ISO 8871-5:2017
English language
18 pages
sale 10% off
Preview
sale 10% off
Preview

e-Library read for
1 day

Standards Content (sample)

SLOVENSKI STANDARD
SIST EN ISO 8871-5:2017
01-februar-2017
1DGRPHãþD
SIST EN ISO 8871-5:2014
Deli iz elastomera za parenteralne farmacevtske oblike - 5. del: Funkcionalne
zahteve in preskušanje (ISO 8871-5:2016)

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5:

Functional requirements and testing (ISO 8871-5:2016)

Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung -

Teil 5: Funktionelle Anforderungen und Prüfung (ISO 8871-5:2016)
Éléments en élastomère pour administration parentérale et dispositifs à usage
pharmaceutique - Partie 5 : Exigences fonctionnelles et essais (ISO 8871-5:2016)
Ta slovenski standard je istoveten z: EN ISO 8871-5:2016
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8871-5:2017 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 8871-5:2017
---------------------- Page: 2 ----------------------
SIST EN ISO 8871-5:2017
EN ISO 8871-5
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2016
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 8871-5:2014
English Version
Elastomeric parts for parenterals and for devices for
pharmaceutical use - Part 5: Functional requirements and
testing (ISO 8871-5:2016)

Éléments en élastomère pour administration Elastomere Teile für Parenteralia und für Geräte zur

parentérale et dispositifs à usage pharmaceutique - pharmazeutischen Verwendung - Teil 5: Funktionelle

Partie 5: Exigences fonctionnelles et essais (ISO 8871- Anforderungen und Prüfung (ISO 8871-5:2016)

5:2016)
This European Standard was approved by CEN on 6 August 2016.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8871-5:2016 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 8871-5:2017
EN ISO 8871-5:2016 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 8871-5:2017
EN ISO 8871-5:2016 (E)
European foreword

This document (EN ISO 8871-5:2016) has been prepared by Technical Committee ISO/TC 76

"Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical

use" in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” the

secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by May 2017 and conflicting national standards shall be

withdrawn at the latest by May 2017.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent

rights.
This document supersedes EN ISO 8871-5:2014.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,

Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France,

Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,

Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 8871-5:2016 has been approved by CEN as EN ISO 8871-5:2016 without any

modification.
---------------------- Page: 5 ----------------------
SIST EN ISO 8871-5:2017
---------------------- Page: 6 ----------------------
SIST EN ISO 8871-5:2017
INTERNATIONAL ISO
STANDARD 8871-5
Second edition
2016-10-15
Elastomeric parts for parenterals and
for devices for pharmaceutical use —
Part 5:
Functional requirements and testing
Éléments en élastomère pour administration parentérale et dispositifs
à usage pharmaceutique —
Partie 5: Exigences fonctionnelles et essais
Reference number
ISO 8871-5:2016(E)
ISO 2016
---------------------- Page: 7 ----------------------
SIST EN ISO 8871-5:2017
ISO 8871-5:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 8871-5:2017
ISO 8871-5:2016(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Requirements .......................................................................................................................................................................................................... 2

4.1 Penetrability .............................................................................................................................................................................................. 2

4.2 Fragmentation ......................................................................................................................................................................................... 2

4.3 Self-sealing and aqueous solution tightness ................................................................................................................. 2

4.4 Aqueous solution tightness .......................................................................................................................................................... 2

5 Preparation of elastomeric closures for testing .................................................................................................................. 2

5.1 Sampling ....................................................................................................................................................................................................... 2

5.2 Cleaning ......................................................................................................................................................................................................... 2

5.3 Sterilization ................................................................................................................................................................................................ 2

Annex A (normative) Test for penetrability .................................................................................................................................................. 3

Annex B (normative) Test for fragmentation .............................................................................................................................................. 4

Annex C (normative) Test for self-sealing and dye solution tightness .............................................................................. 6

Annex D (normative) Test for dye solution tightness.......................................................................................................................... 8

Bibliography .............................................................................................................................................................................................................................10

© ISO 2016 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 8871-5:2017
ISO 8871-5:2016(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO’s adherence to the WTO principles in the Technical

Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information

The committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood

processing equipment for medical and pharmaceutical use.

This second edition cancels and replaces the first edition (ISO 8871-5:2005), which has been technically

revised.

ISO 8871 consists of the following parts, under the general title Elastomeric parts for parenterals and for

devices for pharmaceutical use:
— Part 1: Extractables in aqueous autoclavates
— Part 2: Identification and characterization
— Part 3: Determination of released-particle count
— Part 4: Biological requirements and test methods
— Part 5: Functional requirements and testing
iv © ISO 2016 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 8871-5:2017
ISO 8871-5:2016(E)
Introduction

Elastomeric or rubber closures for pharmaceutical use are used in combination with vials and many

times in conjunction with piercing devices. There are three functional parameters which are important

to the piercing process. These are penetrability, fragmentation and self-sealing. The three functional

tests described in this part of ISO 8871 can be used as a reference method for testing elastomeric

closures that are pierced using injection needles made from metal. In addition, the aqueous solution

tightness test can be used to verify the effectiveness of the sealing of a specific closure/vial combination.

© ISO 2016 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 8871-5:2017
---------------------- Page: 12 ----------------------
SIST EN ISO 8871-5:2017
INTERNATIONAL STANDARD ISO 8871-5:2016(E)
Elastomeric parts for parenterals and for devices for
pharmaceutical use —
Part 5:
Functional requirements and testing
1 Scope

This part of ISO 8871 specifies requirements and test methods for functional parameters o

...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.