I.S. EN ISO 3826-4:2015
Current
The latest, up-to-date edition.
PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
Hardcopy , PDF
English
01-01-2015
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National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Dimensions
5 Design
6 Requirements
7 Packaging
8 Labelling
9 Anticoagulant and/or preservative solution
Annex A (normative) - Chemical tests
Annex B (normative) - Physical 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
Defines requirements, including performance requirements, for apheresis blood bag systems with integrated features.
| DocumentType |
Standard
|
| Pages |
50
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 3826-4:2015 | Identical |
| ISO 3826-4:2015 | Identical |
| ISO 3826-2:2008 | Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets |
| EN ISO 23908:2013 | Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011) |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| EN ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) |
| EN 15986:2011 | Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates |
| EN ISO 10993-11:2009 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006) |
| ISO 3826-3:2006 | Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features |
| EN ISO 10993-10:2013 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) |
| EN ISO 10993-4:2017 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) |
| EN ISO 3826-2:2008 | Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008) |
| ISO 3826-1:2013 | Plastics collapsible containers for human blood and blood components Part 1: Conventional containers |
| ISO 10993-10:2010 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| EN ISO 1135-4 : 2015 COR 2016 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015) |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO 8536-4:2010 | Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed |
| EN ISO 15747:2011 | Plastic containers for intravenous injections (ISO 15747:2010) |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 1135-4:2015 | Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed |
| EN ISO 3826-3:2007 | Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826-3:2006) |
| EN ISO 10993-12:2012 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
| ISO 3696:1987 | Water for analytical laboratory use — Specification and test methods |
| EN ISO 3696:1995 | Water for analytical laboratory use - Specification and test methods (ISO 3696:1987) |
| EN ISO 3826-1:2013 | Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013) |
| ISO 23908:2011 | Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 15747:2010 | Plastic containers for intravenous injections |
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