ISO 8536-8:2004

Infusion equipment for medical use — Part 8: Infusion equipment for use with pressure infusion apparatus

ISO 8536-8:2004 applies to sterilized infusion sets for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar).

Matériel de perfusion à usage médical — Partie 8: Matériel de perfusion pour utilisation avec des appareils de perfusion sous pression

General Information

• Status: Withdrawn
• Publication Date: 11-Aug-2004
• Withdrawal Date: 11-Aug-2004
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
• Drafting Committee: ISO/TC 76/WG 1 - Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment
• Current Stage: 9599 - Withdrawal of International Standard
• Completion Date: 10-Jun-2015

Relations

• Revised: ISO 8536-8:2015 - Infusion equipment for medical use — Part 8: Infusion sets for single use with pressure infusion apparatus
• Effective Date: 16-Feb-2013

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 8536-8
First edition
2004-08-15


Infusion equipment for medical use —
Part 8:
Infusion equipment for use with pressure
infusion apparatus
Matériel de perfusion à usage médical —
Partie 8: Matériel de perfusion pour utilisation avec des appareils de
perfusion sous pression





Reference number
ISO 8536-8:2004(E)
©
ISO 2004

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ISO 8536-8:2004(E)
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ii © ISO 2004 – All rights reserved

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ISO 8536-8:2004(E)
Contents Page
Foreword. iv
1 Scope. 1
2 Normative references. 1
3 General requirements. 1
4 Designation. 4
4.1 Infusion set. 4
4.2 Air-inlet device. 4
5 Materials. 4
6 Physical requirements. 5
6.1 Particulate contamination. 5
6.2 Tensile strength. 5
6.3 Leakage. 5
6.4 Male conical fitting. 5
6.5 Injection site. 5
6.6 Fluid filter. 5
6.7 Flow rate of infusion fluid . 5
6.8 Closure-piercing device. 5
6.9 Air-inlet device. 5
6.10 Drip chamber and drip tube . 5
6.11 Tubing. 5
6.12 Flow regulator. 5
6.13 Protective caps. 6
6.14 Storage volume. 6
7 Chemical requirements. 6
8 Biological requirements. 6
9 Packaging. 6
10 Labelling. 6
10.1 Unit container. 6
10.2 Shelf or multi-unit container . 7
Annex A (normative) Physical tests . 8
Annex B (normative) Chemical tests.9
Annex C (normative) Biological tests. 10
Bibliography . 11

© ISO 2004 – All rights reserved iii

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ISO 8536-8:2004(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 8536-8 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
iv © ISO 2004 – All rights reserved

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INTERNATIONAL STANDARD ISO 8536-8:2004(E)

Infusion equipment for medical use —
Part 8:
Infusion equipment for use with pressure infusion apparatus
1 Scope
This part of ISO 8536 gives users information on sterilized infusion sets for single use with pressure infusion
equipment up to a maximum of 200 kPa (2 bar).
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 594-2:1998, 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 15223, Medical devices — Symbols to be used with medical device labels, labelling and information to be
supplied
IEC 60601-2-24, Medical electrical equipment — Part 2-24: Particular requirements for the safety of infusion
pumps and controllers
3 General requirements
3.1 The nomenclature to be used for components of infusion sets and of a separate air-inlet device is given
in Figures 1, 2 and 3. These figures illustrate examples of the configuration of infusion sets and air-inlet
devices; other
...