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ISO 15674:2009

Cardiovascular implants and artificial organs -- Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags

General information

Withdrawn from 15.08.2016
ICS Groups
11.040.40 Implants for surgery, prosthetics and orthotics
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.08.2016
Main
ISO 15674:2016
Main
ISO 15674:2009
Main
ISO 15674:2001
ISO 15674:2009 specifies requirements for sterile, single-use, extracorporeal hard-shell cardiotomy/venous reservoir systems and soft venous reservoir bags intended for use as a blood reservoir during cardiopulmonary bypass (CPB) surgery.
ISO 15674:2009 applies only to the blood reservoir aspects for multifunctional systems which can have integral parts such as blood-gas exchangers (oxygenators), blood filters, defoamers, blood pumps, etc.

Required fields are indicated with *

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PDF
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Paper
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Standard monitoring
English (PDF 151 KB)

Related products

Main

ISO 15674:2016

Cardiovascular implants and artificial organs -- Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
Newest version Valid from 15.08.2016
Main

EVS-EN ISO 14630:2012

Non-active surgical implants - General requirements (ISO 14630:2012)
Newest version Valid from 04.01.2013
Main

EVS-EN ISO 16061:2021

Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)
Newest version Valid from 15.04.2021
Main

EVS-EN ISO 15001:2011

Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
Newest version Valid from 02.11.2011

Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English