BS EN ISO 15747:2019

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Plastic containers for intravenous injections

Published By	Publication Date	Number of Pages
BSI	2019	26

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Categories: 11.040.20 - Transfusion, infusion and injection equipment, BSI

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Description

This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.

This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.

NOTE In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.

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PDF Pages	PDF Title
2	National foreword
4	European foreword
5	Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
8	Foreword
9	1 Scope 2 Normative references 3 Terms and definitions
10	4 Requirements 4.1 Physical requirements 4.1.1 Manufacturing process compatibility
11	4.1.2 Resistance to temperature, pressure and leakage 4.1.3 Resistance to dropping 4.1.4 Transparency 4.1.5 Water vapour permeability 4.1.6 Particulate contamination 4.1.7 Cover 4.1.8 Access port — Penetration ability of the insertion point 4.1.9 Access port — Adhesion strength of the infusion device and impermeability of the insertion point
12	4.1.10 Access port — Tightness of the injection point 4.1.11 Hanger 4.1.12 Identification 4.2 Chemical requirements 4.2.1 Requirements for the raw container or the sheeting 4.2.2 Requirements for the test fluid
13	4.3 Biological requirements 4.3.1 Impermeability for microorganisms 4.3.2 Migration 5 Application of tests
14	Annex A (normative) Physical tests
17	Annex B (normative) Chemical tests
20	Annex C (normative) Biological tests
22	Annex D (normative) Reference spike
24	Bibliography

Additional information

Status	Revision Underway
Pages	26
Publication Date	2019-03-11
ISBN	978 0 580 97797 8
Standard Number	BS EN ISO 15747:2019
Title	Plastic containers for intravenous injections
Identical National Standard Of	ISO 15747:2018, EN ISO 15747
Replaces	BS EN ISO 15747:2011, BS EN ISO 15747:2010
Descriptors	Blood transfusion equipment, Containers, Physical testing, Plastics, Bags, Biological analysis and testing, Medical equipment, Chemical analysis and testing, Performance, Bottles, Drug administration, Parenteral infusion equipment
Publisher	BSI
Committee	CH/212
ICS Codes	11.040.20 - Transfusion, infusion and injection equipment

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BS EN ISO 15747:2019

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