UNE-EN ISO 1135-3:2017
Current
The latest, up-to-date edition.
Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)
Hardcopy , PDF
Spanish, Castilian, English
02-11-2017
This part of ISO 1135 specifies requirements for types of blood-taking sets for medical use in order to ensure functional interchangeability of transfusion equipment. It is applicable to sterilized blood-taking sets intended for single use only.The materials and the components of the sets are validated by various test methods.The manufacturer shall select appropriate test methods to comply with the requirements laid down in this part of ISO 1135.Secondary aims of this part of ISO 1135 are to providea)specifications relating to the quality and performance of materials used in transfusion equipment;b)a unified presentation of terms and designations for such equipment.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 1135.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
Asociación Española de Normalización
|
| 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 |
| ISO 1773:1997 | Laboratory glassware — Narrow-necked boiling flasks |
| 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 |
| 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 |
| 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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