15/30314236 DC : 0
NA
NA
Status of Standard is Unknown
BS ISO 15676 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - REQUIREMENTS FOR SINGLE-USE TUBING PACKS FOR CARDIOPULMONARY BYPASS AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)
Available format(s)
Hardcopy , PDF
Language(s)
English
Publisher
€22.71
Excluding VAT
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirement
5 Tests and measurements
6 Information supplied by the manufacturer
7 Packaging
Bibliography
BS ISO 15676.
| Committee |
CH/150/2
|
| DocumentType |
Draft
|
| Pages |
18
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
| ISO 11137-1:2006 | Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 14937:2009 | Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ASTM D 792 : 2013 : REDLINE | Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement |
| ISO 9352:2012 | Plastics — Determination of resistance to wear by abrasive wheels |
| ISO 34-1:2015 | Rubber, vulcanized or thermoplastic — Determination of tear strength — Part 1: Trouser, angle and crescent test pieces |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| ISO 10993-7:2008 | Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals |
| ISO 1183-1:2012 | Plastics — Methods for determining the density of non-cellular plastics — Part 1: Immersion method, liquid pyknometer method and titration method |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 11134:1994 | Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ASTM D 638 : 2014 : REDLINE | Standard Test Method for Tensile Properties of Plastics |
| ISO 527-1:2012 | Plastics — Determination of tensile properties — Part 1: General principles |
| ISO 868:2003 | Plastics and ebonite — Determination of indentation hardness by means of a durometer (Shore hardness) |
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