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)
02-22-2017
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
ISO 1135-3:2016 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.ISO 1135-3:2016 also aims to providea) specifications relating to the quality and performance of materials used in transfusion equipment, and b) a unified presentation of terms for such equipment.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-3:2016.
| Committee |
CEN/TC 205
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| SS-EN ISO 1135-3 : 2017 | Identical |
| NF EN ISO 1135-3 : 2017 | Identical |
| NEN EN ISO 1135-3 : 2017 | Identical |
| DIN EN ISO 1135-3:2014-12 (Draft) | Identical |
| DIN EN ISO 1135-3 E : 2017 | Identical |
| UNI EN ISO 1135-3 : 2017 | Identical |
| UNE-EN ISO 1135-3:2017 | Identical |
| PN EN ISO 1135-3 : 2017 | Identical |
| I.S. EN ISO 1135-3:2017 | Identical |
| SN EN ISO 1135-3 : 2017 | Identical |
| NS EN ISO 1135-3 : 2017 | Identical |
| BS EN ISO 1135-3:2017 | Identical |
| ISO 1135-3:2016 | Identical |
| DIN EN ISO 1135-3:2017-05 | 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 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 |
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.