iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

EN ISO 7199:2014

(Main)

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012)

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012)

ISO 7199:2009 specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.
ISO 7199:2009 also applies to heat exchangers that are integral parts of oxygenators and to external equipment unique to the use of the device.

Kardiovaskuläre Implantate und künstliche Organe - Blutgasaustauscher (Oxygenatoren) (ISO 7199:2009 + Amd 1:2012)

Diese Internationale Norm legt Anforderungen an sterile extrakorporale Blutgasaustauscher (Oxygenatoren) zum Einmalgebrauch fest, die zur Zufuhr von Sauerstoff in das und zur Entfernung von Kohlendioxid aus dem menschliche(n) Blut bestimmt sind.
Diese Internationale Norm gilt auch für Wärmeaustauscher, die in Oxygenatoren integriert sind, und für Außengeräte, die allein für den Gebrauch mit dem Gerät bestimmt sind.
Diese Internationale Norm gilt nicht für:
-   implantierte Oxygenatoren;
-   Flüssigkeits-Oxygenatoren;
-   extrakorporale Kreisläufe (Blutschlauchsysteme);
-   separate Wärmeaustauscher;
-   separate Hilfsgeräte.

Implants cardiovasculaires et organes artificiels - Échangeurs gaz/sang extracorporels (oxygénateurs) (ISO 7199:2009 + Amd 1:2012)

L'ISO 7199:2009 précise les prescriptions relative aux échangeurs gaz/sang extracorporels stériles (oxygénateurs), à usage unique, destinés à oxygéner le sang des patients et à en éliminer le dioxyde de carbone.
L'ISO 7199:2009 s'applique également aux échangeurs thermiques qui font partie intégrante des oxygénateurs extracorporels, et aux seuls accessoires nécessaires à l'utilisation du dispositif.

Vsadki (implantati) za srce in ožilje ter umetni organi - Izmenjevalniki krvnih plinov (ISO 7199:2009 + Amd 1:2012)

Standard EN ISO 7199 + A1 določa zahteve za sterilne zunajtelesne izmenjevalnike krvnih plinov za enkratno uporabo, ki so namenjeni za dovajanje kisika in odvajanje ogljikovega dioksida iz človeške krvi.

General Information

Status
Withdrawn
Publication Date
05-Aug-2014
Withdrawal Date
24-Jan-2017
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
CEN/TC 205 - Non-active medical devices
Drafting Committee
CEN/TC 205 - Non-active medical devices
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
25-Jan-2017
Directive
2006/42/EC - Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast)
93/11/EEC - Release of the N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers (Commission Directive)
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN ISO 7199:2014 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012)

Relations

Replaces
EN 12022:1999 - Blood gas exchangers
Effective Date
13-Aug-2014
Replaced By
EN ISO 7199:2017 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
Effective Date
01-Feb-2017

Buy Standard

EN ISO 7199:2014EN ISO 7199:2014
PreviousNext
Standard
EN ISO 7199:2014
English language
25 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 7199:2014
01-oktober-2014
1DGRPHãþD
SIST EN 12022:2000
Vsadki (implantati) za srce in ožilje ter umetni organi - Izmenjevalniki krvnih plinov
(ISO 7199:2009 + Amd 1:2012)
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO
7199:2009 + Amd 1:2012)
Kardiovaskuläre Implantate und künstliche Organe - Blutgasaustauscher (Oxygenatoren)
(ISO 7199:2009 + Amd 1:2012)
Implants cardiovasculaires et organes artificiels - Échangeurs gaz/sang extracorporels
(oxygénateurs) (ISO 7199:2009 + Amd 1:2012)
Ta slovenski standard je istoveten z: EN ISO 7199:2014
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 7199:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 7199:2014

---------------------- Page: 2 ----------------------

SIST EN ISO 7199:2014

EUROPEAN STANDARD
EN ISO 7199

NORME EUROPÉENNE

EUROPÄISCHE NORM
August 2014
ICS 11.040.40 Supersedes EN 12022:1999
English Version
Cardiovascular implants and artificial organs - Blood-gas
exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012)
Implants cardiovasculaires et organes artificiels - Kardiovaskuläre Implantate und künstliche Organe -
Échangeurs gaz/sang extracorporels (oxygénateurs) (ISO Blutgasaustauscher (Oxygenatoren) (ISO 7199:2009 + Amd
7199:2009 + Amd 1:2012) 1:2012)
This European Standard was approved by CEN on 17 July 2014.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7199:2014 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 7199:2014
EN ISO 7199:2014 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .4
2

---------------------- Page: 4 ----------------------

SIST EN ISO 7199:2014
EN ISO 7199:2014 (E)
Foreword
The text of ISO 7199:2009 + Amd 1:2012 has been prepared by Technical Committee ISO/TC 150 “Implants
for surgery” of the International Organization for Standardization (ISO) and has been taken over as EN
ISO 7199:2014 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is
held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by February 2015, and conflicting national standards shall be withdrawn
at the latest by February 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 12022:1999.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Den
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

CEN
EN ISO 8637-1:2020(Main)
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
SIST EN ISO 8637-1:2020

ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.
ISO 8637-1:2017 does not apply to:
-      extracorporeal blood circuits;
-      plasmafilters;
-      haemoperfusion devices;
-      vascular access devices;
-      blood pumps;
-      pressure monitors for the extracorporeal blood circuit;
-      air detection devices;
-      systems to prepare, maintain or monitor dialysis fluid;
-      systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;
-      reprocessing procedures and equipment.
NOTE       Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637‑2.

  • Standard
    30 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 7199:2017/A1:2020(Amendment)
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) - Amendment 1: Connectors (ISO 7199:2016/Amd 1:2020)
SIST EN ISO 7199:2017/A1:2020

2019-11-11-JO:  CEN/TC 205 Decision 19/2019 on delinking EN ISO 7199:2017/prA1 from MDD.
DOW = DAV + 36 months

  • Amendment
    15 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 23500-5:2019(Main)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019)
SIST EN ISO 23500-5:2019

This document specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies.
This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.
This document excludes the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other International Standards.
Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis are excluded from this document.

  • Standard
    22 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 23500-1:2019(Main)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2019)
SIST EN ISO 23500-1:2019

1.1  General  This document is the base standard for a number of other standards dealing with water treatment equipment, water, dialysis water, concentrates, and dialysis fluid (ISO 23500 series) and provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, this document functions as a recommended practice.
This document does not address clinical issues that might be associated with inappropriate usage of the water, dialysis water, concentrates, or dialysis fluid. Healthcare professionals involved in the provision of treatment for kidney failure should make the final decision regarding the applications with which these fluids are used, for example, haemodialysis, haemodiafiltration, high-flux haemodialysis, and the reprocessing of dialysers, and need to be aware of the issues that the use of inappropriate fluid quality raises in each of the therapies.
The concepts incorporated in this document should not be considered inflexible or static. The recommendations presented here should be reviewed periodically in order to assimilate increased understanding of the role of dialysis fluid purity in patient outcomes and technological developments.
1.2  Inclusions  This document addresses the user's responsibility for dialysis fluid once the equipment used in its preparation has been delivered and installed.
For the purposes of this document, dialysis fluid includes:
a)    dialysis water (see 3.17 for definition) used for the preparation of dialysis fluid and substitution fluid,
b)     dialysis water used for the preparation of concentrates at the user's facility,
c)    concentrates,
d)    the final dialysis fluid and substitution fluid.
The scope of this document includes
a)    the quality management of equipment used to treat and distribute water used for the preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is infused,
b)    equipment used to prepare concentrate from powder or other highly concentrated media at a dialysis facility, and
c)    preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates.
NOTE       Because water used to prepare dialysis fluid can also be used to reprocess dialysers not marked intended for single use, this aspect of water use is also covered by this document.
1.3  Exclusions  This document does not apply to sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis.

  • Standard
    96 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 23500-3:2019(Main)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2019)
SIST EN ISO 23500-3:2019

This document specifies minimum requirements for water to be used in haemodialysis and related therapies.
This document includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.
This document excludes the operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid. Those operations are the sole responsibility of dialysis professionals. This document does not apply to dialysis fluid regenerating systems.

  • Standard
    27 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 23500-2:2019(Main)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2019)
SIST EN ISO 23500-2:2019

1.1  General  This document is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for haemodialysis or related therapies.
1.2  Inclusions  This document covers devices used to treat potable water intended for use in the delivery of haemodialysis and related therapies, including water used for:
a)    the preparation of concentrates from powder or other highly concentrated media at a dialysis facility;
b)    the preparation of dialysis fluid, including dialysis fluid that can be used for the preparation of substitution fluid;
c)    the reprocessing of dialysers intended for single use where permitted for multiple uses,
d)    the reprocessing of dialysers not specifically marked as intended for single use.
This document includes all devices, piping and fittings between the point at which potable water is delivered to the water treatment system, and the point of use of the dialysis water. Examples of the devices are water purification devices, online water quality monitors (such as conductivity monitors), and piping systems for the distribution of dialysis water.
1.3  Exclusions  This document excludes dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid, sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid, dialysis concentrates, haemodiafiltration systems, haemofiltration systems, systems that process dialysers for multiple uses, and peritoneal dialysis systems. Some of these devices, such as dialysis fluid delivery systems and concentrates, are addressed in other documents such as ISO 23500-4 and ISO 23500‑5,
This document also excludes the on-going surveillance of the purity of water used for dialysis fluid, concentrate preparation, or dialyser reprocessing which is addressed in ISO 23500‑1.

  • Standard
    43 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 23500-4:2019(Main)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2019)
SIST EN ISO 23500-4:2019

This document specifies minimum requirements for concentrates used for haemodialysis and related therapies.
This document is addressed to the manufacturer of such concentrates. In several instances in this document, the dialysis fluid is addressed, which is made by the end user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of the manufacturer.
This document includes concentrates in both liquid and powder forms.  It also includes additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid.
This document also specifies requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
Concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility are excluded from the scope of this document. Although references to dialysis fluid appear herein, this document does not address dialysis fluid as made by the end user. This document also excludes requirements for the surveillance frequency of water purity used for the making of dialysis fluid by the dialysis facility. This document does not address bags of sterile dialysis fluid or sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid.
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.
This document does not cover haemodialysis equipment, which is addressed in IEC 60601-2-16:2012.

  • Standard
    31 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 8637-2:2018(Main)
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
SIST EN ISO 8637-2:2018

This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits.
This document does not apply to:
—          haemodialysers, haemodiafilters or haemofilters;
—          plasmafilters;
—          haemoperfusion devices;
—          vascular access devices;
—          blood pumps;
—          pressure monitors for the extracorporeal blood circuit;
—          air detection devices;
—          systems to prepare, maintain or monitor dialysis fluid;
—          systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.
NOTE 1    Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637‑1, and requirements for plasmafilters are specified in ISO 8637‑3.
NOTE 2    Extracorporeal blood tubing sets can also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.

  • Standard
    27 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 7199:2017(Main)
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
SIST EN ISO 7199:2017

ISO 7199:2016 specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.
ISO 7199:2016 also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.
ISO 7199:2016 also applies to external equipment unique to the use of the oxygenator.
ISO 7199:2016 does not apply to
-      implanted oxygenators,
-      liquid oxygenators,
-      extracorporeal circuits (blood tubing),
-      separate heat exchangers,
-      separate ancillary devices, and
-      separate arterial line filter.

  • Standard
    27 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
prEN ISO 7199(Main)
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO/DIS 7199:2023)
oSIST prEN ISO 7199:2023

ISO 7199:2016 specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.
ISO 7199:2016 also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.
ISO 7199:2016 also applies to external equipment unique to the use of the oxygenator.
ISO 7199:2016 does not apply to
- implanted oxygenators,
- liquid oxygenators,
- extracorporeal circuits (blood tubing),
- separate heat exchangers,
- separate ancillary devices, and
- separate arterial line filter.

  • Draft
    19 pages
    English language
    sale 10% off
    e-Library read for
    1 day