EN ISO 15747:2005

Plastics containers for intravenous injection (ISO 15747:2003)

This International Standard contains requirements related to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals. This International Standard is applicable to plastic containers for parenterals having one or more chambers and
having a total nominal capacity in the range from to , such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.
50 ml 5 000 ml

Kunststoffbehältnisse für intravenöse Injektionen (ISO 15747:2003)

Diese Internationale Norm legt Anforderungen zur sicheren Handhabung sowie die physikalische, chemische
und biologische Prüfung von Kunststoffbehältnissen für parenterale Injektionen fest.
Diese Internationale Norm gilt für Kunststoffbehältnisse für parenterale Injektionen mit einer oder mehreren
Kammern und einer Gesamt-Nennfüllmenge zwischen 50 ml und 5 000 ml, wie Beutel aus Folie oder durch
Spritzguss gefertigte Flaschen aus Kunststoff für Lösungen zur direkten Infusion (Injektion).

Récipients en plastique pour injections intraveineuses (ISO 15747:2003)

Plastični zbiralniki za intravenske injekcije (ISO 15747:2003)

General Information

• Status: Withdrawn
• Publication Date: 15-Mar-2005
• Withdrawal Date: 14-Apr-2010
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/SS S03 - Syringes
• Drafting Committee: CEN/SS S03 - Syringes
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Apr-2010
• Completion Date: 15-Apr-2010
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 15747:2005 - Plastics containers for intravenous injection (ISO 15747:2003)

Relations

• Replaced By: EN ISO 15747:2010 - Plastic containers for intravenous injections (ISO 15747:2010)
• Effective Date: 17-Apr-2010

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15747:2005
01-junij-2005
3ODVWLþQL]ELUDOQLNL]DLQWUDYHQVNHLQMHNFLMH,62
Plastics containers for intravenous injection (ISO 15747:2003)
Kunststoffbehältnisse für intravenöse Injektionen (ISO 15747:2003)
Récipients en plastique pour injections intraveineuses (ISO 15747:2003)
Ta slovenski standard je istoveten z: EN ISO 15747:2005
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 15747:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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INTERNATIONAL ISO
STANDARD 15747
First edition
2003-11-15
Plastics containers for intravenous
injection
Récipients en plastique pour injections intraveineuses

Reference number
ISO 15747:2003(E)
©
ISO 2003

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ISO 15747:2003(E)
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ii ISO 2003 – All rights reserved

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ISO 15747:2003(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 Physical requirements . 2
4.2 Chemical requirements . 3
4.3 Biological requirements . 4
5 Identification . 4
6 Application of tests . 4
Annex A (normative) Physical tests . 6
Annex B (normative) Chemical tests . 9
Annex C (normative) Biological tests . 12
Annex D (informative) Further biological tests . 15
Bibliography . 16
©
ISO 2003 – All rights reserved iii

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ISO 15747:2003(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 in
...