NF EN ISO 8536-10

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).

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Main informations

Collections

National standards and national normative documents

Publication date

June 2005

Number of pages

16 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 - 21/06/2005

International kinship

ISO 8536-10:2004

European kinship

EN ISO 8536-10:2004
Sumary
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:

  1. 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.
  2. Units with injection site (UIS) or check valve (UCV).
  3. Stoppers (S) or adapters (A).
Standard replaced by (1)
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.

Table of contents
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Désignation
    2
  • 4 Matériaux
    2
  • 5 Exigences physiques
    2
  • 5.1 Absence de bulles d'air
    2
  • 5.2 Contamination particulaire
    2
  • 5.3 Résistance à la rupture
    3
  • 5.4 Étanchéité
    3
  • 5.5 Adaptateurs à raccords coniques mâle et/ou femelle
    3
  • 5.6 Protecteurs
    3
  • 5.7 Manipulation des robinets
    3
  • 5.8 Unité équipée d'un site d'injection
    3
  • 5.9 Unité à valve anti-retour
    3
  • 6 Exigences chimiques
    3
  • 7 Exigences biologiques
    3
  • 7.1 Stérilité
    3
  • 7.2 Pyrogènes
    4
  • 7.3 Hémolyse
    4
  • 8 Emballage
    4
  • 9 Étiquetage
    4
  • 9.1 Emballage primaire
    4
  • 9.2 Emballage secondaire
    4
  • Annexe A (normative) Essais physiques
    6
  • Annexe B (normative) Essais chimiques
    8
  • Annexe C (normative) Essais biologiques
    9
  • Bibliographie
    10
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