EN ISO 8536-4:2013/A1:2013
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010/AMD 1:2013)
Amendment of
Superseded date
05-02-2020
Published date
06-03-2013
Publisher
Foreword
1 Scope
2 Normative references
3 General requirements
4 Designation
5 Materials
6 Physical requirements
7 Chemical requirements
8 Biological requirements
9 Labelling
10 Packaging
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
Describes requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.
| Committee |
TC 205
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NF EN ISO 8536-4 : 2013 | Identical |
| NEN EN ISO 8536-4 : 2013 | Identical |
| PN EN ISO 8536-4 : 2013 AMD 1 2013 | Identical |
| UNI EN ISO 8536-4 : 2013 | Identical |
| I.S. EN ISO 8536-4:2013 | Identical |
| SN EN ISO 8536-4 : 2013 AMD 1 2013 | Identical |
| BS EN ISO 8536-4 : 2013 | Identical |
| ISO 8536-4:2010 | Identical |
| DIN EN ISO 8536-4:2013-07 | Identical |
| NBN EN ISO 8536-4 : 2013 AMD 1 2013 | Identical |
| NS EN ISO 8536-4 : 2013 AMD 1 2013 | Identical |
| UNE-EN ISO 8536-4:2013 | Identical |
| I.S. EN 60601-2-24:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS |
| BS EN ISO 8536-13:2016 | Infusion equipment for medical use Graduated flow regulators for single use with fluid contact |
| I.S. EN ISO 8536-13:2016 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 13: GRADUATED FLOW REGULATORS FOR SINGLE USE WITH FLUID CONTACT (ISO 8536-13:2016) |
| I.S. EN ISO 8536-10:2015 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-10:2015) |
| CEI EN 60601-2-24 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS |
| BS EN ISO 8536-10:2015 | Infusion equipment for medical use Accessories for fluid lines for single use with pressure infusion equipment |
| UNE-EN ISO 8536-8:2015 | Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015) |
| 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) |
| UNE-EN ISO 8536-13:2017 | Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016) |
| BS EN ISO 3826-4:2015 | Plastics collapsible containers for human blood and blood components Aphaeresis blood bag systems with integrated features |
| ISO 8536-10:2015 | Infusion equipment for medical use Part 10: Accessories for fluid lines for single use with pressure infusion equipment |
| ISO 8536-13:2016 | Infusion equipment for medical use Part 13: Graduated flow regulators for single use with fluid contact |
| UNE-EN ISO 8536-10:2015 | Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015) |
| EN ISO 8536-13:2016 | Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016) |
| EN ISO 8536-10:2015 | Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015) |
| BS EN 60601-2-24:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
| 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 |
| EN 60601-2-24:2015 | Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| ISO 80000-4:2006 | Quantities and units Part 4: Mechanics |
| ISO/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
| ISO 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| 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 |
| 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 |
| ISO/TS 11135-2:2008 | Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 |
| 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 |
| 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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