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15/30321712 DC : 0

NA
NA

Status of Standard is Unknown

BS ISO 15674 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS
Available format(s)

Hardcopy , PDF

Language(s)

English

Foreword
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
Annex A (normative) - Factors to be considered in
        evaluating performance characteristics
Bibliography

BS ISO 15674.

Committee
CH/150/2
DocumentType
Draft
Pages
16
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 8637:2010 Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
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
ISO/TS 23810:2012 Cardiovascular implants and artificial organs Checklist for preoperative extracorporeal circulation equipment setup
ISO 7199:2016 Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators)
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 14971:2007 Medical devices Application of risk management to medical devices
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
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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