DIN EN ISO 1135-3:2017-05
Current
The latest, up-to-date edition.
TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
05-29-2017
National foreword
National Annex NA (informative) - Bibliography
European foreword
Foreword
1 Scope
2 Normative references
3 General requirements
4 Materials
5 Physical requirements
6 Chemical requirements
7 Biological requirements
8 Labelling
9 Packaging
10 Disposal
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 Directive 93/42/EEC
[OJ L 169] aimed to be covered
Bibliography
Gives requirements for types of blood-taking sets for medical use in order to ensure functional interchangeability of transfusion equipment.
| DocumentType |
Standard
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Current
|
| Standards | Relationship |
| ISO 1135-3:2016 | Identical |
| EN ISO 1135-3:2017 | 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 |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| 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 |
| ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods |
| DIN 13097-4:2009-08 | HYPODERMIC NEEDLES - PART 4: POINT GEOMETRY, REQUIREMENTS AND TESTING |
| DIN EN ISO 8536-14:2015-08 (Draft) | INFUSION EQUIPMENT FOR MEDICAL USE - PART 14: CLAMPS AND FLOW REGULATORS FOR TRANSFUSION AND INFUSION EQUIPMENT WITHOUT FLUID CONTACT (ISO 8536-14:2016) |
| DIN EN ISO 10993-4:2009-10 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD (ISO 10993-4:2017) |
| ISO 1773:1997 | Laboratory glassware — Narrow-necked boiling flasks |
| DIN EN 80416-1:2009-11 | BASIC PRINCIPLES FOR GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - PART 1: CREATION OF GRAPHICAL SYMBOLS FOR REGISTRATION |
| EN ISO 7864:2016 | Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) |
| DIN EN ISO 9626 E : 2016 | STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE OF MEDICAL DEVICES - REQUIREMENTS AND TEST METHODS (ISO 9626:2016) |
| 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 |
| DIN EN ISO 3826-2:2008-11 | PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 2: GRAPHICAL SYMBOLS FOR USE ON LABELS AND INSTRUCTION LEAFLETS |
| 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) |
| DIN 13097-5:2008-11 | HYPODERMIC NEEDLES - PART 5: SOCKETS, HUBS AND CONNECTIONS - REQUIREMENTS AND TESTING |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 8536-14:2016 | Infusion equipment for medical use Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact |
| 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 |
| DIN EN ISO 291:2008-08 | PLASTICS - STANDARD ATMOSPHERES FOR CONDITIONING AND TESTING |
| 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) |
| DIN ISO 3696:1991-06 | WATER FOR ANALYTICAL LABORATORY USE - SPECIFICATION AND TEST METHODS |
| 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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