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ISO standards
Does anyone have a source for ISO standards at a university or something? I need like 4 different standards and don't really want to waste 150 on it. I'd assumed the LA public library system would have it but alas.
Comments
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I might have access at the library at the school I work at. If you tell me the specific standards, I'll check.
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ISO 10993-1:2009 & ISO/DIS 10993-1 [Under development] Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
ISO 10993-2:2006 Biological evaluation of medical devices Part 2: Animal welfare requirements
ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-4:2017 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
ISO 10993-6:2016 Biological evaluation of medical devices—Part 6: Tests for local effects after implantation
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
ISO 10993-8:2001 Biological evaluation of medical devices Part 8: Selection of reference materials (withdrawn)
ISO 10993-9:1999 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2006 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials (available in English only)
ISO 10993-13:1998 Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-14:2001 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
ISO 10993-15:2000 Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys
ISO 10993-16:2017 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
ISO 10993-18:2005 & ISO/CD 10993-18 [Under development] Biological evaluation of medical devices Part 18: Chemical characterization of materials
ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO/TS 10993-20:2006 Biological evaluation of medical devices Part 20: Principles and methods for immunotoxicology testing of medical devices
ISO/TR 15499:2012 Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management processISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and times
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 11135-1, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for 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 products — Radiation — Part 2: Establishing the sterilization dose
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 13408-1, Aseptic processing of health care products — Part 1: General requirements
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14160, Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
ISO 14937, 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 deviceshttps://www.iso.org/committee/53080/x/catalogue/p/1/u/0/w/0/d/0
Materials Testinghttps://www.iso.org/committee/53122/x/catalogue/
Active Implant Standardshttps://www.iso.org/standard/61749.html?browse=tc
Non-active Implant Standards -
I looked up all those in the library I have access to, and found one inexact but potentially useful match, for ISO 10993. I've slacked you a PDF.
