ISO 15676:2016
(Main)Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
ISO 15676:2016 specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). This document is applicable to all medical tubing intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with peristaltic pumps during (short-term, i.e. 24 h) ECMO procedures. The sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as "sterile". It is applicable only to the tubing aspects for multifunctional systems that may have integral components such as blood gas exchangers (oxygenators), reservoirs, blood filters, defoamers, blood pumps, etc.
Implants cardiovasculaires et organes artificiels — Exigences pour les paquets de tubes à usage unique pour pontage cardiopulmonaire et oxygénation des membranes extracorporelles
General Information
- Status
- Published
- Publication Date
- 14-Aug-2016
- Technical Committee
- ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems
- Drafting Committee
- ISO/TC 150/SC 2/WG 4 - Blood gas exchangers
- Current Stage
- 9093 - International Standard confirmed
- Start Date
- 26-May-2023
- Completion Date
- 13-Dec-2025
Relations
- Effective Date
- 06-Jun-2022
- Effective Date
- 29-Mar-2014
Overview
ISO 15676:2016 - "Cardiovascular implants and artificial organs - Requirements for single‑use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)" specifies safety, performance and information requirements for medical tubing used in CPB and ECMO. The standard applies to all single‑use tubing intended for extracorporeal blood circuits and focuses on tubing characteristics, testing, labelling and manufacturer reporting. It is intended to help manufacturers, regulators and clinical users ensure tubing safety and functional compatibility with extracorporeal systems.
Key topics and technical requirements
Scope and applicability
- Covers tubing packs and tubing aspects of multifunctional systems (oxygenators, reservoirs, filters, pumps, etc.).
- Includes specific provisions for tubing used with peristaltic/roller pumps in short‑term CPB and longer‑term ECMO applications.
- Sterility and non‑pyrogenicity requirements apply when tubing packs are labelled as “sterile.”
Biological requirements
- Sterility and non‑pyrogenicity verified per the standard’s test clauses.
- Biocompatibility requirements for all components contacting blood; compliance typically demonstrated in line with ISO 10993 series.
Physical and material characteristics
- Blood‑path integrity (no leakage) and dimensional conformity (inner diameter, wall thickness, segment lengths) per user specifications.
- Material properties to be tested/reported: durometer hardness, ultimate elongation, tensile strength, tear strength, brittle point, specific gravity.
Performance characteristics
- Priming volume: measured or calculated and reported across supplied tubing sizes.
- Life‑to‑failure testing and spallation (particle generation) assessment, particularly for tubing used in roller/peristaltic pumps.
- Shelf life and cleanliness reporting.
Information and packaging
- Minimum labelling and manufacturer information requirements, including technical data, packaging, and shipping details to support clinical selection and quality processes.
Applications and who uses ISO 15676:2016
- Tubing and medical device manufacturers - design verification, material selection, production QA, and regulatory submissions.
- OEMs of CPB/ECMO systems - component selection and system compatibility testing.
- Regulatory and quality teams - conformity assessment, risk management, and clinical documentation.
- Hospitals, perfusionists and clinical engineers - informed procurement, device selection (priming volume, intended pump compatibility), and safe clinical use.
Related standards (examples)
ISO 15676 references standards commonly used together for testing and sterilization, such as:
- ISO 10993 series (biological evaluation),
- ISO 11135 / ISO 11137 / ISO 17665 (sterilization processes),
- ISO 11607 (packaging for sterile devices),
- ASTM and ISO material test methods (tensile, durometer, tear tests).
ISO 15676:2016 helps bridge material and performance testing with clinical needs, enabling safer extracorporeal blood circuits and clearer manufacturer-to‑user information.
ISO 15676:2016 - Cardiovascular implants and artificial organs -- Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
ISO 15676:2016 - Cardiovascular implants and artificial organs -- Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
Frequently Asked Questions
ISO 15676:2016 is a standard published by the International Organization for Standardization (ISO). Its full title is "Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)". This standard covers: ISO 15676:2016 specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). This document is applicable to all medical tubing intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with peristaltic pumps during (short-term, i.e. 24 h) ECMO procedures. The sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as "sterile". It is applicable only to the tubing aspects for multifunctional systems that may have integral components such as blood gas exchangers (oxygenators), reservoirs, blood filters, defoamers, blood pumps, etc.
ISO 15676:2016 specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). This document is applicable to all medical tubing intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with peristaltic pumps during (short-term, i.e. 24 h) ECMO procedures. The sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as "sterile". It is applicable only to the tubing aspects for multifunctional systems that may have integral components such as blood gas exchangers (oxygenators), reservoirs, blood filters, defoamers, blood pumps, etc.
ISO 15676:2016 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 15676:2016 has the following relationships with other standards: It is inter standard links to ISO 20957-9:2016/Amd 1:2019, ISO 15676:2005. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase ISO 15676:2016 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of ISO standards.
Standards Content (Sample)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15676
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2015-05-08 2015-08-08
Cardiovascular implants and artificial organs —
Requirements for single-use tubing packs for
cardiopulmonary bypass and extracorporeal membrane
oxygenation (ECMO)
Implants cardiovasculaires et organes artificiels — Exigences pour les paquets de tubes à usage unique
pour pontage cardiopulmonaire et oxygénation des membranes extracorporelles
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 15676:2015(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2015
ISO/DIS 15676:2015(E)
© ISO 2015
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2015 – All rights reserved
ISO/DIS 15676:2015(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 3
4.1 Biological characteristics . 3
4.1.1 Sterility and non-pyrogenicity . 3
4.1.2 Biocompatibility . 3
4.2 Physical characteristics . 3
4.2.1 General. 3
4.2.2 Dimensions . 3
4.2.3 Material properties . 3
4.3 Performance characteristics. 3
4.3.1 Priming volume . 3
4.3.2 Life to failure testing . 4
4.3.3 Spallation . 4
4.3.4 Shelf life . 4
5 Tests and measurements . 4
5.1 General . 4
5.2 Biological characteristics . 4
5.2.1 Sterility and non-pyrogenicity . 4
5.2.2 Biocompatibility . 4
5.3 Physical characteristics . 5
5.3.1 Determination of blood pathway integrity . 5
5.3.2 Connections . 5
5.3.3 Tubing material property testing . 5
5.4 Performance characteristics. 5
5.4.1 Determination of tubing life . 5
5.4.2 Spallation in tubing used in roller pumps . 5
5.4.3 Shelf life . 6
6 Information supplied by the manufacturer . 6
6.1 Information to be given on the tubing pack . 6
6.1.1 Information to be given on the unit container . 6
6.1.2 Information to be given on the shipping container . 6
6.2 Information to be given on the accompanying documents . 7
6.3 Information to be given in the accompanying documents in a prominent form . 7
6.4 Information to be provided by manufacturer upon request . 7
7 Packaging . 7
Bibliography . 8
ISO/DIS 15676:2015(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received. www.iso.org/patents
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT), see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.
This second edition cancels and replaces the first edition (ISO 15676:2005), which has been technically
revised.
iv © ISO 2015 – All rights reserved
ISO/DIS 15676:2015(E)
Introduction
The intent of this International Standard is to ensure that medical grade tubing in single-use tubing
packs for the transfer of blood and fluid during the period of cardiopulmonary bypass (CPB) and
extracorporeal membrane oxygenation (ECMO) is adequately tested for both safety and function.
The user commonly provides the specifications for the tubing pack. Furthermore, the purpose of this
International Standard is to ensure that the tubing pack characteristics be appropriately disclosed in the
labelling and manufacturing information package. Tubing performance characteristics are specifically
addressed within the context of this International Standard as a component part of a single-use tubing
pack.
This International Standard therefore contains recommended procedures to evaluate such medical
grade tubing intended for use during CPB procedures and ECMO. Test procedures to determine the
material characteristics, the useful life of the tubing when used in a roller pump, and cleanliness are
described. The limits for these characteristics are not specified.
This International Standard also includes minimum reporting requirements. Ready identification of the
performance characteristics should assist the user in the selection of such medical grade tubing for the
procedure appropriate to the patient and procedure. This information may be useful in a clinic’s quality
control process that aims to improve the safety of CPB and ECMO procedures.
This International Standard makes reference to other International Standards, which references
methods for the determination of characteristics common to medical devices.
Requirements for animal and clinical studies are not included in this International Standard. Such
studies, however, may be part of a manufacturer’s quality system.
This International Standard contains only those requirements that are specific to such medical grade
tubing for use during CPB and ECMO. Non-specific requirements are covered by reference to other
International Standards listed in the Normative References section.
DRAFT INTERNATIONAL STANDARD ISO/DIS 15676:2015(E)
Cardiovascular implants and artificial organs —
Requirements for single-use tubing packs for
cardiopulmonary bypass and extracorporeal membrane
oxygenation (ECMO)
1 Scope
This International Standard specifies requirements for single-use tubing packs for cardiopulmonary
bypass and extracorporeal membrane oxygenation (ECMO). This International Standard is applicable
to all medical tubing intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane
oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with
peristaltic pumps during (short- term, i.e. < 6 h duration) CPB surgery, or (long-term, i.e. > 24 h) ECMO
procedures. The sterility and non- pyrogenicity provisions of this International Standard are applicable
to tubing packs labelled as “sterile”.
This International Standard is applicable only to the tubing aspects for multifunctional systems that
may have integral components such as blood gas exchangers (oxygenators), reservoirs, blood filters,
defoamers, blood pumps, etc.
2 Normative references
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 34-1, Rubber, vulcanized or thermoplastic — Determination of tear strength — Part 1: Trouser, angle
and crescent test pieces
ISO 527-1, Plastics — Determination of tensile properties — Part 1: General principles
ISO 868, Plastics and ebonite — Determination of indentation hardness by means of a durometer (Shore
hardness)
ISO 9352, Plastics — Determination of resistance to wear by abrasive wheels
ISO 1183−1, Plastics — Methods for determining the density of non-cellular plastics — Part 1: Immersion
method, liquid pyknometer method and
...
INTERNATIONAL ISO
STANDARD 15676
Second edition
2016-08-15
Cardiovascular implants and artificial
organs — Requirements for single-
use tubing packs for cardiopulmonary
bypass and extracorporeal membrane
oxygenation (ECMO)
Implants cardiovasculaires et organes artificiels — Exigences pour les
paquets de tubes à usage unique pour pontage cardiopulmonaire et
oxygénation des membranes extracorporelles
Reference number
©
ISO 2016
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 3
4.1 Biological characteristics . 3
4.1.1 Sterility and non-pyrogenicity . 3
4.1.2 Biocompatibility . 3
4.2 Physical characteristics . 3
4.2.1 General. 3
4.2.2 Dimensions . 3
4.2.3 Material properties . 3
4.3 Performance characteristics. 3
4.3.1 Priming volume . 3
4.3.2 Life to failure testing . 4
4.3.3 Spallation . 4
4.3.4 Shelf life . 4
5 Tests and measurements . 4
5.1 General . 4
5.2 Biological characteristics . 4
5.2.1 Sterility and non-pyrogenicity . 4
5.2.2 Biocompatibility . 4
5.3 Physical characteristics . 5
5.3.1 Blood pathway integrity . 5
5.3.2 Connections . 5
5.3.3 Tubing material property testing . 5
5.4 Performance characteristics. 5
5.4.1 Tubing life . 5
5.4.2 Spallation in tubing used in roller pumps . 5
5.4.3 Shelf life . 6
6 Information supplied by the manufacturer . 6
6.1 Information on the tubing pack . 6
6.1.1 Information on the unit container . 6
6.1.2 Information on the shipping container . 6
6.2 Information on the accompanying documents . 7
6.3 Information in the accompanying documents in a prominent form . 7
6.4 Information to be provided by manufacturer upon request . 7
7 Packaging . 7
Bibliography . 8
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.
This second edition cancels and replaces the first edition (ISO 15676:2005), which has been technically
revised.
iv © ISO 2016 – All rights reserved
Introduction
The intent of this document is to ensure that medical grade tubing in single-use tubing packs for the
transfer of blood and fluid during the period of cardiopulmonary bypass (CPB) and extracorporeal
membrane oxygenation (ECMO) is adequately tested for both safety and function. The user commonly
provides the specifications for the tubing pack. Furthermore, the purpose of this document is to ensure
that the tubing pack characteristics be appropriately disclosed in the labelling and manufacturing
information package. Tubing performance characteristics are specifically addressed within the context
of this document as a component part of a single-use tubing pack.
This document therefore contains recommended procedures to evaluate such medical grade tubing
intended for use during CPB procedures and ECMO. Test procedures to determine the material
characteristics, the useful life of the tubing when used in a roller pump, and cleanliness are described.
The limits for these characteristics are not specified.
This document also includes minimum reporting requirements. Ready identification of the performance
characteristics should assist the user in the selection of such medical grade tubing for the procedure
appropriate to the patient and procedure. This information may be useful in a clinic’s quality control
process that aims to improve the safety of CPB and ECMO procedures.
This document makes reference to other International Standards, which references methods for the
determination of characteristics common to medical devices.
Requirements for animal and clinical studies are not included in this document. Such studies, however,
may be part of a manufacturer’s quality system.
This document contains only those requirements that are specific to such medical grade tubing for
use during CPB and ECMO. Non-specific requirements are covered by reference to other International
Standards listed in the Normative References section.
INTERNATIONAL STANDARD ISO 15676:2016(E)
Cardiovascular implants and artificial organs —
Requirements for single-use tubing packs for
cardiopulmonary bypass and extracorporeal membrane
oxygenation (ECMO)
1 Scope
This document specifies requirements for single-use tubing packs for cardiopulmonary bypass and
extracorporeal membrane oxygenation (ECMO). This document is applicable to all medical tubing
intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO),
but specific requirements and tests are included for tubing intended for use with peristaltic pumps
during (short-term, i.e. <6 h duration) CPB surgery or (long-term, i.e. >24 h) ECMO procedures. The
sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as
“sterile”.
This document is applicable only to the tubing aspects for multifunctional systems that may have
integral components such as blood gas exchangers (oxygenators), reservoirs, blood filters, defoamers,
blood pumps, etc.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 34-1, Rubber, vulcanized or thermoplastic — Determination of tear strength — Part 1: Trouser, angle
and crescent test pieces
ISO 527-1, Plastics — Determination of tensile properties — Part 1: General principles
ISO 9352, Plastics — Determination of resistance to wear by abrasive wheels
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 11137-2, Sterilization of health care
...
ISO 15676:2016 establishes crucial guidelines for single-use tubing packs tailored for cardiopulmonary bypass (CPB) and extracorporeal membrane oxygenation (ECMO). This standard's scope is particularly significant as it addresses the essential requirements for medical tubing utilized in these high-stakes procedures, ensuring reliability and safety in patient care. One of the strengths of ISO 15676:2016 lies in its detailed specifications for tubing intended for use with peristaltic pumps during ECMO, particularly during short-term applications of up to 24 hours. This focus is vital given the sensitivity and complexity of ECMO procedures, where the integrity and functionality of the tubing directly impact patient outcomes. The document also emphasizes sterility and non-pyrogenicity, which are non-negotiable parameters for any medical device intended for direct patient interaction. These provisions reinforce the standard's commitment to maintaining high-quality safety protocols. Moreover, ISO 15676:2016's relevance is underscored by its application to multifunctional systems that may incorporate various integral components, such as blood gas exchangers and blood pumps. This approach ensures that all components work coherently within a system, enhancing overall operational efficiency while minimizing the risk of complications associated with inadequate tubing performance. Additionally, the standard articulates specific test requirements that support the efficacy and safety of the tubing packs, providing manufacturers with a clear framework for compliance. This fosters innovation and accountability in the design and production of these vital medical devices. In summary, ISO 15676:2016 is a pivotal standard that not only delineates critical requirements for single-use tubing packs in cardiopulmonary bypass and ECMO but also underscores the importance of safety, functionality, and compatibility within multifunctional systems in the medical field. Its comprehensive nature makes it a fundamental reference for manufacturers and medical professionals alike, ensuring optimal patient care during cardiopulmonary procedures.
ISO 15676:2016 표준은 심혈관 이식물 및 인공 장기에 대한 요구사항을 규정하며, 심폐 우회 및 체외막 산소화(ECMO)를 위한 일회용 튜빙 팩에 중점을 두고 있습니다. 이 문서는 심폐 우회(CPB) 및 체외막 산소화(ECMO)에 사용되는 모든 의료용 튜빙에 적용되며, 특히 에를 고려하여 설계된 특정 요구사항과 테스트가 포함되어 있습니다. 이 표준은 단기(24시간) ECMO 절차 중 사용되는 페리스타틱 펌프용 튜빙에 대한 요구사항을 상세히 명시하고 있습니다. ISO 15676:2016의 강점 중 하나는 비병원성(sterility) 및 비열성(non-pyrogenicity) 조항이 포함되어 있다는 점입니다. 의료기기에서 감염방지와 안전성이 중요한 만큼, 이 표준은 '멸균'으로 표시된 튜빙 팩에 적합하다는 점에서 신뢰성을 제공합니다. 표준은 다기능 시스템에서 혈액 가스 교환기, 저수조, 혈액 필터, 탈포기, 혈액 펌프 등과 같은 통합 구성 요소들이 포함된 경우에도 적용 가능하다는 점에서 다루는 범위가 넓습니다. 이 문서는 심장 수술 및 ECMO 치료에 대해 보다 안전하고 효과적인 장비 사용을 보장하기 위한 핵심 지침으로, 의료 분야에서의 응용 가능성을 높이며 기술 표준에 대한 요구를 충족시킵니다..UTF-8
ISO 15676:2016は、心肺バイパスおよび体外膜型酸素化（ECMO）用の使い捨てチュービングパックに関する要件を規定しています。この標準は、心肺バイパス（CPB）およびECMO用の医療チューブに関連するすべての要件に適用されます。特に、短期間（24時間）でのECMO手順におけるペリスタルティックポンプ用として使用されるチューブに対する具体的な要件および試験が含まれています。 ISO 15676:2016の強みは、その厳格な衛生基準にあります。この文書では、"滅菌"とラベル付けされたチュービングパックに対する滅菌および非発熱性の規定が明確に示されています。また、多機能システムにおけるチュービングの側面にも焦点を当てており、血液ガス交換器、貯蔵庫、血液フィルター、脱泡器、血液ポンプなど、統合コンポーネントを持つシステムにおいてもその適用が考慮されています。 そのため、ISO 15676:2016は、医療現場において心肺バイパスおよびECMOに関与するすべての機器の安全性を保証するための重要な指針となります。この標準に従うことで、医療従事者は高いレベルの患者安全を確保し、術後合併症のリスクを低減することができます。現在の医療環境においてこの標準の関連性は非常に高く、国内外での規制遵守を促進するものです。
Die ISO 15676:2016 ist ein bedeutendes Dokument, das Anforderungen an Einweg-Schlauchpakete für extrakorporale Membranoxygenierung (ECMO) und kardiopulmonale Bypass (CPB) definiert. Die Standardisierung ist speziell auf medizinisches Schlauchmaterial ausgerichtet, das für diese kritischen Anwendungen bestimmt ist, und bietet damit einen klaren Rahmen für die Sicherheit und Leistungsfähigkeit dieser Produkte. Ein herausragendes Merkmal der ISO 15676:2016 ist der Fokus auf die spezifischen Anforderungen und Tests, die für die Verwendung von Schläuchen mit peristaltischen Pumpen während kurzfristiger ECMO-Verfahren (bis zu 24 Stunden) vorgeschrieben sind. Diese Klarheit in den Anforderungen ist von enormer Bedeutung, da sie sicherstellt, dass die Produkte, die in solchen sensiblen Verfahren eingesetzt werden, den höchsten Standards der Qualität und Zuverlässigkeit entsprechen. Der Standard legt ebenfalls fest, dass Sterilität und Nicht-Pyrogenität für Schlauchpakete, die als "steril" gekennzeichnet sind, unbedingt eingehalten werden müssen. Dies erhöht die Patientensicherheit erheblich, da die Verwendung von kontaminierten Materialien bei ECMO- und CPB- Verfahren zu schweren Komplikationen führen kann. Die documentierten Vorgaben zur Sterilität unterstützen Hersteller dabei, ihre Prozesse zu optimieren und den strengen Anforderungen des Marktes gerecht zu werden. Ein weiterer wesentlicher Aspekt ist die Augenmerklegung auf multifunktionale Systeme, die integrierte Komponenten wie Blutgasaustauscher, Reservoirs, Blutfilter, Entschäumer und Blutpumpen enthalten können. Die ISO 15676:2016 bietet hier spezifische Anleitungen für die Schlauchaspekte in solchen komplexen Systemen, was dazu beiträgt, die Integration und Kompatibilität zwischen verschiedenen Komponenten zu gewährleisten. Insgesamt ist die ISO 15676:2016 aufgrund ihres umfassenden Ansatzes, der klaren Definition der Anforderungen und der Berücksichtigung der speziellen Bedürfnisse im Bereich kardiopulmonaler Bypass und ECMO von entscheidender Relevanz. Sie bildet eine grundlegende Grundlage für Hersteller und Anwender, um die Qualität und Sicherheit der eingesetzten Produkte zu gewährleisten.
La norme ISO 15676:2016 établit des exigences claires et précises concernant les kits de tubes à usage unique pour le contournement cardiopulmonaire (CPB) et l'oxygénation membranaire extracorporelle (ECMO). Son champ d'application est bien défini, détaillant les spécifications nécessaires pour les tubes médicaux destinés à ces procédures critiques, tout en mettant l'accent sur l'utilisation avec des pompes péristaltiques lors des procédures ECMO à court terme, spécifiquement limitées à 24 heures. Un des points forts de la norme est son engagement envers la stérilité et la non-pyrogénicité, garantissant que seuls les kits étiquetés "stériles" répondent aux exigences de sécurité essentielles pour une utilisation médicale. Cela renforce la confiance des professionnels de la santé dans la manipulation et l'application de ces dispositifs, critiques dans des contextes d'urgence ou de soins intensifs. De plus, la norme ISO 15676:2016 apporte une pertinence significative dans le cadre complexe des systèmes multifonctionnels qui intègrent divers composants tels que les échangeurs de gaz sanguins, les réservoirs, les filtres à sang, ainsi que les pompes à sang. En stipulant des exigences spécifiques uniquement pour l'aspect tubulaire, ce standard permet une meilleure intégration et une utilisation optimale des dispositifs médicaux dans l'ensemble des processus de CPB et d'ECMO. En résumé, la norme ISO 15676:2016 joue un rôle crucial dans la standardisation des pratiques pour les dispositifs utilisés en soins critiques, participant ainsi à l'amélioration des résultats pour les patients lors de procédures délicates et complexes. Les installations médicales peuvent donc s'appuyer sur cette norme pour garantir un niveau élevé de qualité et de sécurité.
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