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14/30303657 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS EN ISO 1135-3 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SET FOR SINGLE USE
Available format(s)

Hardcopy , PDF

Superseded date

02-28-2017

Language(s)

English

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 EC Directive
         93/42/EEC on medical devices

BS EN ISO 1135-3.

Committee
CH/212
DocumentType
Draft
Pages
21
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

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 1773:1997 Laboratory glassware Narrow-necked boiling flasks
EN ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
EN 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 3826-2:2008)
EN ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
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
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)
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
EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
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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