13/30273308 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 3826-4 - PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES
Hardcopy , PDF
31-08-2015
English
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Dimensions and designation
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
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC on Medical devices
Bibliography
BS EN ISO 3826-4
| Committee |
CH/212
|
| DocumentType |
Draft
|
| Pages |
42
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| 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 15986:2011 | Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates |
| ISO 3826-3:2006 | Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features |
| ISO 3826-1:2013 | Plastics collapsible containers for human blood and blood components Part 1: Conventional containers |
| ISO 8536-4:2010 | Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed |
| ISO 1135-4:2015 | Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed |
| ISO 3696:1987 | Water for analytical laboratory use — Specification and test methods |
| 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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