Name: EN ISO 1135-3:2017
Brand: CEN

Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)

Published date

02-22-2017

Publisher

Comite Europeen de Normalisation

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