NF EN ISO 8536-10

NF EN ISO 8536-10

November 2015
Standard Current

Infusion equipment for medical use - Part 10 : accessories for fluid lines for single use with pressure infusion equipment

ISO 8536-10:2015 applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8.ISO 8536-10:2015 includes the following:a) two-way stopcocks, three-way stopcocks, four-way stopcocks, and stopcocks manifold;b) units with injection site or check valve;c) stoppers or adapters.

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Main informations

Collections

National standards and national normative documents

Publication date

November 2015

Number of pages

20 p.

Reference

NF EN ISO 8536-10

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-123-10

Print number

1

International kinship

ISO 8536-10:2015

European kinship

EN ISO 5536-10:2015
Sumary
Infusion equipment for medical use - Part 10 : accessories for fluid lines for single use with pressure infusion equipment

ISO 8536-10:2015 applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8.

ISO 8536-10:2015 includes the following:

a) two-way stopcocks, three-way stopcocks, four-way stopcocks, and stopcocks manifold;

b) units with injection site or check valve;

c) stoppers or adapters.

Replaced standards (1)
NF EN ISO 8536-10
June 2005
Standard Cancelled
Infusion equipment for medical use - Part 10 : accessories for fluid lines for use with pressure infusion equipment

ISO 8536-10:2004 applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8. ISO 8536-10:2004 includes: Two-way stopcocks (2SC), three-way stopcocks (3SC), four-way stopcocks (4SC) and stopcocks manifold (SM). 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 possible stopcock positions, e.g. 3/4-way stopcock for three-way stopcock with four possible positions.Units with injection site (UIS) or check valve (UCV).Stoppers (S) or adapters (A).

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Matériaux
  • 4 Exigences physiques
  • 5 Exigences chimiques
  • 6 Exigences biologiques
  • 7 Emballage
  • 8 Étiquetage
  • 9 Mise au rebut
  • Annexe A (normative) Essais physiques
  • Annexe B (normative) Essais chimiques
  • Annexe C (normative) Essais biologiques
  • Annexe ZA(informative) Relation entre la présente norme européenne et les exigences essentielles de la Directive UE 93/42/CEE applicables aux dispositifs médicaux
  • Bibliographie
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