Part 10: Accessories for fluid lines for use with pressure infusion equipment Matériel de perfusion à usage médical — iTeh STANDARD PREVIEW Partie 10: Accessoires de tubulures pour utilisation avec des appareils de perfusion sous pression (standards.iteh.ai) ISO 8536-10:2004 https://standards.iteh.ai/catalog/standards/sist/2df11d8e-ce16-4b8e-b064- e2bd56273410/iso-8536-10-2004
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iTeh STANDARD PREVIEW
(standards.iteh.ai) ISO 8536-10:2004 https://standards.iteh.ai/catalog/standards/sist/2df11d8e-ce16-4b8e-b064- e2bd56273410/iso-8536-10-2004
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ISO 8536-10 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. iTeh STANDARD PREVIEW ISO 8536 consists of the following parts, under the general title Infusion equipment for medical use: — Part 1: Infusion glass bottles (standards.iteh.ai) — Part 2: Closures for infusion bottles ISO 8536-10:2004 — Part 3: Aluminium caps for infusion bottles https://standards.iteh.ai/catalog/standards/sist/2df11d8e-ce16-4b8e-b064- e2bd56273410/iso-8536-10-2004 — 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 10: Accessories for fluid lines for use with pressure infusion equipment
1 Scope This part of ISO 8536 applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8.
This part of ISO 8536 includes:
a) Two-way stopcocks (2SC), three-way stopcocks (3SC), four-way stopcocks (4SC) and stopcocks manifold (SM);
NOTE Designation of a stopcock depends on the number of connections. The number of possible functional positions can be expressed by addition of a complementary note, using a diagonal stroke and a numeral indicating the number of iTeh STANDARD PREVIEW possible stopcock positions, e.g. 3/4-way stopcock for three-way stopcock with four possible positions. b) units with injection site (UIS) or(standards.iteh.ai) check valve (UCV); c) stoppers (S) or adapters (A). ISO 8536-10:2004 https://standards.iteh.ai/catalog/standards/sist/2df11d8e-ce16-4b8e-b064- 2 Normative references e2bd56273410/iso-8536-10-2004 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, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings
ISO 7886-1, Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 8536-4, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
ISO 8536-8, Infusion equipment for medical use — Part 8: Infusion equipment for use with pressure infusion apparatus
ISO 15223, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied
Designation of two-way stopcock (2SC) for infusions under pressure (P):
Two-way stopcock ISO 8536-10 – 2SC –P
Designation of three-way stopcock (3SC) for infusions under pressure (P):
Three-way stopcock ISO 8536-10 – 3SC –P
Designation of four-way stopcock (4SC) for infusions under pressure (P):
Four-way stopcock ISO 8536-10 – 4SC –P
Designation of stopcock manifold (SM) for infusions under pressure (P):
Stopcock manifold ISO 8536-10 – SM –P
Designation of two-stopcock manifold (2SM) for infusions under pressure (P):
Stopcock manifold ISO 8536-10 – 2SM –P
Designation of three-stopcock manifold (3SM) for infusions under pressure (P):
Stopcock manifold ISO 8536-10 – 3SM –P
iTeh STANDARD PREVIEW Designation of four-stopcock manifold (4SM) for infusions under pressure (P): (standards.iteh.ai) Stopcock manifold ISO 8536-10 – 4SM –P ISO 8536-10:2004 Designation of unit with injection site (UIS) for infusions under pressure (P): https://standards.iteh.ai/catalog/standards/sist/2df11d8e-ce16-4b8e-b064- Injection unit ISO 8536-10 – UIS –P e2bd56273410/iso-8536-10-2004
Designation of unit with check valve (UCV) for infusions under pressure (P):
Injection unit ISO 8536-10 – UCV –P
Designation of stopper (S) for infusions under pressure (P):
Stopper ISO 8536-10 – S –P
Designation of adapter (A) for infusions under pressure (P):
Adapter ISO 8536-10 – A –P
4 Materials
The materials from which the accessories as given in Clause 3 are manufactured shall comply with the requirements as specified in Clauses 5, 6 and 7.
5 Physical requirements
5.1 Avoidance of air bubbles
All components of accessories shall be designed such that no air bubbles are detected in flow channels when tested as specified in A.1.
The accessories shall be manufactured under conditions that minimize particulate contamination. The fluid pathway surfaces shall be smooth and clean. When tested as specified in A.2, the number of particles shall not exceed the contamination index.
5.3 Tensile strength
When tested as specified in A.3, the accessories and connections between components shall withstand a static tensile force of not less than 15 N for 15 s.
In the case of stopcocks, connections between plug and housing shall withstand this tensile force when in any position.
5.4 Leakage
The accessories shall be impermeable to air, microorganisms, and fluids. There shall be no leakage of air or water. Stopcocks shall be tight in any plug position. When tested as specified in A.4, there shall be no leakage of air or water.
iTeh STANDARD PREVIEW
5.5 Adapters with female and/or male conical fittings (standards.iteh.ai) Adapters shall be provided with a connector with female conical fitting and/or a connector with male conical fitting according to ISO 594-2. When tested as specified in A.5, no water shall leak from the point of connection. ISO 8536-10:2004 https://standards.iteh.ai/catalog/standards/sist/2df11d8e-ce16-4b8e-b064- 5.6 Protective caps e2bd56273410/iso-8536-10-2004
ISO 8536-4 applies.
5.7 Manipulation of stopcocks
Stopcocks and stopcock manifolds shall be so designed that when tested as specified in A.6, flow channels can be opened and closed without any adverse effect on the functionality of adjacent components.
5.8 Unit with injection site
Units with injection site shall enable injection. When tested as specified in A.7, no more than 10 drops per batch and no more than 2 drops per unit shall be lost.
5.9 Unit with check valve
When tested as specified in A.8, the valve shall close tightly to prevent any leakage of water.
The accessories in their unit container shall have been subjected to a validated sterilization process (see Bibliography).
7.2 Pyrogens
The accessories shall be assessed for freedom from pyrogens using a suitable test, and the results shall indicate that the accessories are free from pyrogens. Guidance on testing for pyrogenicity is given in ISO 8536-4.
7.3 Haemolysis
The accessories shall be assessed for freedom from haemolytic constituents and the result shall indicate that the accessories are free from haemolytic reactions.
Guidance on testing for haemolytic constituents is given in ISO 10993-4.
8 Packaging
ISO 8536-4 applies. iTeh STANDARD PREVIEW
(standards.iteh.ai) 9 Labelling ISO 8536-10:2004 9.1 Unit container https://standards.iteh.ai/catalog/standards/sist/2df11d8e-ce16-4b8e-b064- e2bd56273410/iso-8536-10-2004 The unit container shall be labelled with the following minimum information: a) a textual description of the contents, e.g. stopcock manifold for single use; b) indication that the accessory is sterile, using the graphical symbol as given in ISO 15223; c) indication that the accessory is free from pyrogens, or that the accessory is free from bacterial endotoxins; d) indication that the accessory is for single use only, or equivalent wording, or the graphical symbol according to ISO 15223; e) instructions for use, including warnings, e.g. about detached protective caps (instructions for use may also take the form of an insert); f) the lot (batch) designation, prefixed by the word LOT, or using the graphical symbol according to ISO 15223; g) the wording “Safe for use with pressure infusion equipment” (the name and type of pressure infusion equipment shall be given by the manufacturer); h) identification block of designation according to Clause 3 (e.g. ISO 8536-10 – SM – P); i) letter “P” which stands for pressure and the type, the height of which shall stand out clearly from surrounding text; j) name or logo and address of manufacturer or supplier; k) year and month of expiry, accompanied by appropriate wording or the graphical symbol according to ISO 15223.
If the available space is too small to give all this information in legible characters and/or symbols, the information may be reduced to f) and k). In this case the information as required in this subclause shall be given on the label of the next bigger shelf or multi-unit container.
The shelf or multi-unit container shall be labelled with the following minimum information: a) a textual description of the contents, e.g. stopcock manifold for single use; b) the lot (batch) designation, prefixed by the word LOT, or using the graphical symbol according to ISO 15223; c) the wording “Safe for use with pressure infusion equipment” (the name and type of pressure infusion equipment shall be given by the manufacturer); d) identification block of designation according to Clause 3 (e.g. ISO 8536-10 – SM – P); e) letter “P” which stands for pressure and the type, the height of which shall stand out clearly from surrounding text; f) name or logo and address of manufacturer or supplier; g) year and month of expiry, accompanied by appropriate wording or the graphical symbol according to ISO 15223; h) storage note.
iTeh STANDARD PREVIEW
(standards.iteh.ai) ISO 8536-10:2004 https://standards.iteh.ai/catalog/standards/sist/2df11d8e-ce16-4b8e-b064- e2bd56273410/iso-8536-10-2004
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