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
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English, French
24-07-2015
Important note : Users cannot be edited or removed once added to your Multi user PDF.
ISO 3826-4:2015 specifies requirements including performance requirements for aphaeresis blood bag systems with integrated features. Aphaeresis blood bag systems need not contain all of the integrated features identified in this part of ISO 3826.
The integrated features refer to: needle stick protection device, leucocyte filter, sterile barrier filter, pre-collection sampling device, red blood cell storage bag, plasma storage bag, platelet storage bag, polymorphonucleic (e.g. stem) cell storage bag, post-collection sampling devices, and connections for storage solutions, anticoagulant, and replacement fluid.
ISO 3826-4:2015 specifies additional requirements for blood bag systems used to collect varying quantities of blood components or cells by apheresis. It can be used on automated or semi-automated blood collection systems.
| Committee |
ISO/TC 76
|
| DevelopmentNote |
Supersedes ISO/DIS 3826-4. (07/2015)
|
| DocumentType |
Standard
|
| Pages |
31
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| NF EN ISO 3826-4 : 2015 | Identical |
| NBN EN ISO 3826-4 : 2015 | Identical |
| NEN EN ISO 3826-4 : 2015 | Identical |
| NS EN ISO 3826-4 : 2015 | Identical |
| I.S. EN ISO 3826-4:2015 | Identical |
| PN EN ISO 3826-4 : 2015 | Identical |
| SN EN ISO 3826-4 : 2015 | Identical |
| UNI EN ISO 3826-4 : 2015 | Identical |
| SS-EN ISO 3826-4:2015 | Identical |
| UNE-EN ISO 3826-4:2015 | Identical |
| BS EN ISO 3826-4:2015 | Identical |
| EN ISO 3826-4:2015 | Identical |
| DIN EN ISO 3826-4:2015-12 | 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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.