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15/30275224 DC : 0

NA
NA

Status of Standard is Unknown

BS ISO 18242 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CENTRIFUGAL BLOOD PUMPS
Available format(s)

Hardcopy , PDF

Language(s)

English

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Tests and measurements to determine
  compliance with this International Standard
6 Information supplied by the manufacturer
7 Packaging

BS ISO 18242.

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 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11658:2012 Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems
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 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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