ISO 1135-4:2015
Current
Current
The latest, up-to-date edition.
Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English, French
Published date
11-30-2015
ISO 1135-4:2015 specifies requirements for single use transfusion gravity sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.
Secondary aims of ISO 1135-4:2015 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with a range of cellular and plasma blood components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2015.
| Committee |
ISO/TC 76
|
| DevelopmentNote |
Supersedes ISO 1135 (04/2001) Supersedes ISO/DIS 1135-4. (12/2015)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| UNI EN ISO 1135-4:2016 | Identical |
| NF EN ISO 1135-4 : 2016 | Identical |
| UNE-EN ISO 1135-4:2016 | Identical |
| NBN EN ISO 1135-4 : 2016 | Identical |
| NEN EN ISO 1135-4 : 2016 | Identical |
| NS EN ISO 1135-4 : 2012 | Identical |
| I.S. EN ISO 1135-4:2015 | Identical |
| PN EN ISO 1135-4 : 2016 | Identical |
| SN EN ISO 1135-4:2016 | Identical |
| UNI EN ISO 1135-4 : 2012-06 | Identical |
| SS-EN ISO 1135-4 : 2016 | Identical |
| BS EN ISO 1135-4:2015 | Identical |
| EN ISO 1135-4 : 2015 COR 2016 | Identical |
| DIN EN ISO 1135-4:2016-06 | Identical |
| NFS 1990 201 : 1990 | Similar to |
| DIN 58360-1:1991-04 | Corresponds |
| 13/30273308 DC : 0 | BS EN ISO 3826-4 - PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES |
| 17/30346437 DC : 0 | BS ISO 18250-7 - CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS FOR HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR INFUSION |
| STANAG 2939 : 0 | MEDICAL REQUIREMENTS FOR BLOOD, BLOOD DONORS AND ASSOCIATED EQUIPMENT |
| I.S. EN ISO 3826-1:2013 | PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013) |
| DIN EN ISO 3826-4:2015-12 | PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015) |
| DIN EN ISO 3826-1:2013-09 | PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013) |
| UNI EN ISO 3826-1 : 2013 | PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS |
| 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) |
| DIN EN ISO 3826-4 E : 2015 | PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015) |
| DIN ISO 15759:2006-05 | Medical infusion equipment - Plastics caps with inserted elastomeric liner for containers manufactured by the blow-fill-seal (BFS) process (ISO 15759:2005) |
| ISO 3826:1993 | Plastics collapsible containers for human blood and blood components |
| PREN ISO 3826-1 : DRAFT 2010 | PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS |
| ISO 3826-1:2013 | Plastics collapsible containers for human blood and blood components Part 1: Conventional containers |
| BS EN ISO 3826-1:2013 | Plastics collapsible containers for human blood and blood components Conventional containers |
| UNE-EN ISO 3826-1:2013 | Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013) |
| EN ISO 3826-1:2013 | Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013) |
| 10/30233840 DC : 0 | BS ISO 3826-1 - PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS |
| 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 15759:2005 | Medical infusion equipment — Plastics caps with inserted elastomeric liner for containers manufactured by the blow-fill-seal (BFS) process |
| ISO 3826-4:2015 | Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features |
| 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 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| EN 15986:2011 | Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates |
| ISO 11135:2014 | Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 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) |
| EN ISO 7864:2016 | Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) |
| ISO 3826-1:2013 | Plastics collapsible containers for human blood and blood components Part 1: Conventional containers |
| ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 291:2008 | Plastics Standard atmospheres for conditioning and testing |
| IEC 80416-1:2008 | Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
| 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 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| 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 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
| EN ISO 14644-1:2015 | Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015) |
| EN ISO 10993-1:2009/AC:2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010) |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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Hardcopy - English
PDF - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
Hardcopy - French
PDF - French
PDF 3 Users - French
PDF 5 Users - French
PDF 9 Users - French
Hardcopy - English
PDF - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
Hardcopy - French
PDF - French
PDF 3 Users - French
PDF 5 Users - French
PDF 9 Users - French
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