Plastic containers for intravenous injections (ISO 15747:2010)
Abstract
ISO 15747:2010 contains requirements that relate to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.
ISO 15747:2010 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.
DIN EN ISO 15747:2012-07 (E)
Plastic containers for intravenous injections (ISO 15747:2010)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………. 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices …………………………………………….
Introduction …………………………………………………………………………………………………………………………………… 4
1 Scope …………………………………………………………………………………………………………………………….. 5
2 Normative references …………………………………………………………………………………………………….. 5
3 Terms and definitions …………………………………………………………………………………………………….. 5
4 Requirements ………………………………………………………………………………………………………………… 6
4.1 Physical requirements ……………………………………………………………………………………………………. 6
4.2 Chemical requirements ………………………………………………………………………………………………….. 7
4.3 Biological requirements …………………………………………………………………………………………………. 8
5 Identification ………………………………………………………………………………………………………………….. 9
6 Application of tests ………………………………………………………………………………………………………… 9
Annex A (normative) Physical tests ……………………………………………………………………………………………… 10
Annex B (normative) Chemical tests …………………………………………………………………………………………….. 13
Annex C (normative) Biological tests ……………………………………………………………………………………………. 16
Bibliography ………………………………………………………………………………………………………………………………… 19