EN ISO 15747:2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Plastic containers for intravenous injections (ISO 15747:2010)
19-10-2011
13-03-2019
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Identification
6 Application of tests
Annex A (normative) - Physical tests
Annex B (normative) - Chemical tests
Annex C (normative) - Biological tests
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC on medical devices
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.
| Committee |
CEN/BT
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NF EN ISO 15747 : 2012 | Identical |
| I.S. EN ISO 15747:2011 | Identical |
| PN EN ISO 15747 : 2011 | Identical |
| BS EN ISO 15747:2019 | Identical |
| ISO 15747:2010 | Identical |
| ISO 15747:2018 | Identical |
| NEN EN ISO 15747 : 2011 | Identical |
| DIN EN ISO 15747:2012-07 | Identical |
| NS EN ISO 15747 : 2011 | Identical |
| BS EN ISO 15747:2011 | Identical |
| NEN EN ISO 15747 : 2019 | Identical |
| I.S. EN ISO 15747:2019 | Identical |
| NBN EN ISO 15747 : 2011 | Identical |
| UNE-EN ISO 15747:2012 | Identical |
| EN ISO 3826-4:2015 | Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015) |
| BS EN ISO 3826-4:2015 | Plastics collapsible containers for human blood and blood components Aphaeresis blood bag systems with integrated features |
| I.S. EN ISO 3826-4:2015 | PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015) |
| ISO 3826-4:2015 | Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features |
| ISO 8536-4:2010 | Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed |