ISO 8536-12:2007
(Main)Infusion equipment for medical use — Part 12: Check valves
Infusion equipment for medical use — Part 12: Check valves
ISO 8536-12:2007 applies to sterilized check valves intended for single use and used with infusion equipment for gravity-feed infusion and/or with pressure infusion apparatus.
Matériel de perfusion à usage médical — Partie 12: Clapet antiretour
General Information
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 8536-12
First edition
2007-04-01
Infusion equipment for medical use —
Part 12:
Check valves
Matériel de perfusion à usage médical —
Partie 12: Clapet antiretour
Reference number
ISO 8536-12:2007(E)
©
ISO 2007
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ISO 8536-12:2007(E)
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ii © ISO 2007 – All rights reserved
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ISO 8536-12:2007(E)
Contents Page
Foreword. iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Designation . 2
5 Materials . 2
6 Physical requirements. 2
6.1 Particulate contamination. 2
6.2 Tensile strength . 2
6.3 Leakage. 2
6.4 Connecting pieces having internal and/or external connector. 2
6.5 Counterflow pressure resistance. 2
6.6 Volumetric flow rate. 3
6.7 Blocking performance. 3
6.8 Opening pressure . 3
6.9 Protective caps . 3
7 Chemical requirements . 3
8 Biological requirements. 3
8.1 Sterility. 3
8.2 Pyrogenicity . 3
8.3 Biocompatibility. 3
9 Packaging . 3
10 Labelling . 3
10.1 Unit container. 3
10.2 Shelf or multi-unit container. 4
Annex A (normative) Physical tests . 5
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ISO 8536-12:2007(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 8536-12 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use.
ISO 8536 consists of the following parts, under the general title Infusion equipment for medical use:
⎯ Part 1: Infusion glass bottles
⎯ Part 2: Closures for infusion bottles
⎯ Part 3: Aluminium caps for infusion bottles
⎯ Part 4: Infusion sets for single use, gravity feed
⎯ Part 5: Burette infusion sets for single use, gravity feed
⎯ Part 6: Freeze drying closures for infusion bottles
⎯ Part 7: Caps made of aluminium-plastics combinations for infusion bottles
⎯ Part 8: Infusion equipment for use with pressure infusion apparatus
⎯ Part 9: Fluid lines for use with pressure infusion equipment
⎯ Part 10: Accessories for fluid lines for use with pressure infusion equipment
⎯ Part 11: Infusion filters for use with pressure infusion equipment
⎯ Part 12: Check valves
iv © ISO 2007 – All rights reserved
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INTERNATIONAL STANDARD ISO 8536-12:2007(E)
Infusion equipment for medical use —
Part 12:
Check valves
1 Scope
This part of ISO 8536 applies to sterilized check valves intended for single use and used with infusion
equipment for gravity-feed infusion and/or with pressure infusion apparatus.
NOTE The functional requirements in this part of ISO 8536 also apply to built-in check valves.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 31-3, Quantities and units — Part 3: Mechanics
ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment —
Part 2: Lock fittings
ISO 8536-4:2004, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
ISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables
in aqueous autoclavates
ISO 8871-2, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification
and characterization
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management system
ISO 15223:2000, Medical devices — Symbols to be used with medical device labels, labelling and information
to be supplied
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
blocking
prevention of counterflow through the valve
3.2
built-in check valve
check valve that is an integrated feature of the infusion set
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ISO 8536-12:2007(E)
3.3
feed rate
rate of flow through an open valve, flow in the forward direction
3.4
leakage rate
rate of counterflow through a closed valve
4 Designation
A check valve (CV) for infusions under gravity and/or pressure (P) is designated as follows:
Check
...
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