ISO 1135-4:2004
Transfusion equipment for medical use — Part 4: Transfusion sets for single use
ISO 1135-4:2004 specifies requirements for single-use transfusion sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.
ISO 1135-4:2004 also specifies requirements for air-inlet devices for use with rigid containers for blood and blood components.
Secondary aims of ISO 1135-4:2004 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets and to present designations for transfusion set components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2004.
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$118.26 NZD
|
|
| HardCopy |
$152.17 NZD
|
|
| Networkable PDF |
Price varies
|
TitlePage - Transfusion equipment for medical use—
TableofContent - Contents Page
Foreword - Foreword
Scope - 1 Scope
NormativeReference - 2 Normative references
Clause1 - 3 General requirements
Subclause2 - 3.1 Nomenclature for components of the transfusion set
Subclause2 - 3.2 Maintenance of sterility
Subclause2 - 3.3 Designation
Subclause3 - 3.3.1 Transfusion set
Subclause3 - 3.3.2 Air-inlet device
Clause1 - 4 Materials
Clause1 - 5 Physical requirements
Subclause2 - 5.1 Particulate contamination
Subclause2 - 5.2 Leakage
Subclause2 - 5.3 Tensile strength
Subclause2 - 5.4 Closure-piercing device
UntitledSubclause3 - 5.4.1 The dimensions of the closure-piercing device shall conform with th...
UntitledSubclause3 - 5.4.2 The closure-piercing device, and the air-inlet device if used, shal...
Subclause2 - 5.5 Air-inlet device
UntitledSubclause3 - 5.5.1 The air-inlet device shall also conform with
UntitledSubclause3 - 5.5.2 The air-inlet device shall be provided with an air filter to preven...
UntitledSubclause3 - 5.5.3 The air-inlet device shall be separate from the closure-piercing de...
UntitledSubclause3 - 5.5.4 If the end of the air-inlet device is connected to an air filter by...
UntitledSubclause3 - 5.5.5 The air filter shall be fitted in such a manner that all air enteri...
Subclause2 - 5.6 Tubing
UntitledSubclause3 - 5.6.1 The tubing, made of flexible material, shall be transparent or suff...
UntitledSubclause3 - 5.6.2 The tubing from the distal end to the drip chamber shall be not les...
Subclause2 - 5.7 Filter for blood and blood components
Subclause2 - 5.8 Drip chamber and drip tube
Subclause2 - 5.9 Flow regulator
Subclause2 - 5.10 Flow rate of blood and blood components
Subclause2 - 5.11 Injection site
Subclause2 - 5.12 Male conical fitting
Subclause2 - 5.13 Protective caps
Clause1 - 6 Chemical requirements
Subclause2 - 6.1 Reducing (oxidizable) matter
Subclause2 - 6.2 Metal ions
Subclause2 - 6.3 Titration acidity or alkalinity
Subclause2 - 6.4 Residue on evaporation
Subclause2 - 6.5 UV absorption of extract solution
Clause1 - 7 Biological requirements
Subclause2 - 7.1 General
Subclause2 - 7.2 Sterility
Subclause2 - 7.3 Pyrogenicity
Subclause2 - 7.4 Haemolysis
Subclause2 - 7.5 Toxicity
Clause1 - 8 Labelling
Subclause2 - 8.1 Unit container
Subclause2 - 8.2 Shelf or multi-unit container
Clause1 - 9 Packaging
UntitledSubclause2 - 9.1 The transfusion set and/or the air-inlet device shall be individually...
UntitledSubclause2 - 9.2 The transfusion sets and/or the air-inlet devices shall be packed and...
AnnexNormative - Physical tests
Clause1 - A.1 Test for particulate contamination
Subclause2 - A.1.1 Principle
Subclause2 - A.1.2 Reagents and materials
UntitledSubclause3 - A.1.2.1 Distilled water
UntitledSubclause3 - A.1.2.2 Non-powdered gloves
UntitledSubclause3 - A.1.2.3 Vacuum filter
Subclause2 - A.1.3 Procedure
Subclause2 - A.1.4 Determination of results
Subclause3 - A.1.4.1 General
Subclause3 - A.1.4.2 Particle counts
Clause1 - A.2 Test for leakage
UntitledSubclause2 - A.2.1 At the beginning of the test, condition the whole system at the tes...
UntitledSubclause2 - A.2.2 Immerse the transfusion set, with one end blocked, in water at
Clause1 - A.3 Measurement of flow rate when using an air-inlet device
Clause1 - A.4 Tests for efficiency of filter for blood and blood components
Subclause2 - A.4.1 Principle
Subclause2 - A.4.2 Reference filter
Subclause2 - A.4.3 Procedure
Subclause3 - A.4.3.1 General
Subclause3 - A.4.3.2 MethodA
Subclause3 - A.4.3.3 MethodB
Subclause2 - A.4.4 Expression of results
Clause1 - A.5 Test of the injection site
AnnexNormative - Chemical tests
Clause1 - B.1 Preparation of extract solutionS
Subclause2 - B.1.1 Extract solutionS
Subclause2 - B.1.2 Blank solution S
Clause1 - B.2 Tests for reducing (oxidizable) matter
Clause1 - B.3 Test for metal ions
Clause1 - B.4 Test for titration acidity or alkalinity
Clause1 - B.5 Test for nonvolatile residue
Clause1 - B.6 Test for absorbance
AnnexNormative - Biological tests
Clause1 - C.1 Test on pyrogenicity
Clause1 - C.2 Tests for biological evaluation
Bibliography - Bibliography
Previous versions
Keep me up-to-date
Sign up to receive updates when there are changes to this standard
Related Information
Similar Standards
-
AS/NZS 2696:1996
Medical devices - Polymer urethral catheters for general medical use
-
AS/NZS 2696:1996 A1
Medical devices - Polymer urethral catheters for general medical use: Amendment 1
-
AS/NZS 3200.2.24:1999
Approval and test specification - Medical electrical equipment - Particular requirements for safety - Infusion pumps and controllers
-
AS/NZS IEC 60601.2.16:2015
Medical electrical equipment - Part 2.16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
TitlePage - Transfusion equipment for medical use—
TableofContent - Contents Page
Foreword - Foreword
Scope - 1 Scope
NormativeReference - 2 Normative references
Clause1 - 3 General requirements
Subclause2 - 3.1 Nomenclature for components of the transfusion set
Subclause2 - 3.2 Maintenance of sterility
Subclause2 - 3.3 Designation
Subclause3 - 3.3.1 Transfusion set
Subclause3 - 3.3.2 Air-inlet device
Clause1 - 4 Materials
Clause1 - 5 Physical requirements
Subclause2 - 5.1 Particulate contamination
Subclause2 - 5.2 Leakage
Subclause2 - 5.3 Tensile strength
Subclause2 - 5.4 Closure-piercing device
UntitledSubclause3 - 5.4.1 The dimensions of the closure-piercing device shall conform with th...
UntitledSubclause3 - 5.4.2 The closure-piercing device, and the air-inlet device if used, shal...
Subclause2 - 5.5 Air-inlet device
UntitledSubclause3 - 5.5.1 The air-inlet device shall also conform with
UntitledSubclause3 - 5.5.2 The air-inlet device shall be provided with an air filter to preven...
UntitledSubclause3 - 5.5.3 The air-inlet device shall be separate from the closure-piercing de...
UntitledSubclause3 - 5.5.4 If the end of the air-inlet device is connected to an air filter by...
UntitledSubclause3 - 5.5.5 The air filter shall be fitted in such a manner that all air enteri...
Subclause2 - 5.6 Tubing
UntitledSubclause3 - 5.6.1 The tubing, made of flexible material, shall be transparent or suff...
UntitledSubclause3 - 5.6.2 The tubing from the distal end to the drip chamber shall be not les...
Subclause2 - 5.7 Filter for blood and blood components
Subclause2 - 5.8 Drip chamber and drip tube
Subclause2 - 5.9 Flow regulator
Subclause2 - 5.10 Flow rate of blood and blood components
Subclause2 - 5.11 Injection site
Subclause2 - 5.12 Male conical fitting
Subclause2 - 5.13 Protective caps
Clause1 - 6 Chemical requirements
Subclause2 - 6.1 Reducing (oxidizable) matter
Subclause2 - 6.2 Metal ions
Subclause2 - 6.3 Titration acidity or alkalinity
Subclause2 - 6.4 Residue on evaporation
Subclause2 - 6.5 UV absorption of extract solution
Clause1 - 7 Biological requirements
Subclause2 - 7.1 General
Subclause2 - 7.2 Sterility
Subclause2 - 7.3 Pyrogenicity
Subclause2 - 7.4 Haemolysis
Subclause2 - 7.5 Toxicity
Clause1 - 8 Labelling
Subclause2 - 8.1 Unit container
Subclause2 - 8.2 Shelf or multi-unit container
Clause1 - 9 Packaging
UntitledSubclause2 - 9.1 The transfusion set and/or the air-inlet device shall be individually...
UntitledSubclause2 - 9.2 The transfusion sets and/or the air-inlet devices shall be packed and...
AnnexNormative - Physical tests
Clause1 - A.1 Test for particulate contamination
Subclause2 - A.1.1 Principle
Subclause2 - A.1.2 Reagents and materials
UntitledSubclause3 - A.1.2.1 Distilled water
UntitledSubclause3 - A.1.2.2 Non-powdered gloves
UntitledSubclause3 - A.1.2.3 Vacuum filter
Subclause2 - A.1.3 Procedure
Subclause2 - A.1.4 Determination of results
Subclause3 - A.1.4.1 General
Subclause3 - A.1.4.2 Particle counts
Clause1 - A.2 Test for leakage
UntitledSubclause2 - A.2.1 At the beginning of the test, condition the whole system at the tes...
UntitledSubclause2 - A.2.2 Immerse the transfusion set, with one end blocked, in water at
Clause1 - A.3 Measurement of flow rate when using an air-inlet device
Clause1 - A.4 Tests for efficiency of filter for blood and blood components
Subclause2 - A.4.1 Principle
Subclause2 - A.4.2 Reference filter
Subclause2 - A.4.3 Procedure
Subclause3 - A.4.3.1 General
Subclause3 - A.4.3.2 MethodA
Subclause3 - A.4.3.3 MethodB
Subclause2 - A.4.4 Expression of results
Clause1 - A.5 Test of the injection site
AnnexNormative - Chemical tests
Clause1 - B.1 Preparation of extract solutionS
Subclause2 - B.1.1 Extract solutionS
Subclause2 - B.1.2 Blank solution S
Clause1 - B.2 Tests for reducing (oxidizable) matter
Clause1 - B.3 Test for metal ions
Clause1 - B.4 Test for titration acidity or alkalinity
Clause1 - B.5 Test for nonvolatile residue
Clause1 - B.6 Test for absorbance
AnnexNormative - Biological tests
Clause1 - C.1 Test on pyrogenicity
Clause1 - C.2 Tests for biological evaluation
Bibliography - Bibliography