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| 标准编号 | 标准名称 | 发布日期 | 实施日期 | 废止日期 | 替换信息 |
|---|---|---|---|---|---|
| ISO 10993-7:2008 | Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals | ||||
| ISO 10993-9:2009 | Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products | ||||
| ISO 10993-8:2000 | Biological evaluation of medical devices -- Part 8: Selection and qualification of reference materials for biological tests | ||||
| ISO 10993-10:2010 | Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization | ||||
| ISO 10993-12:2007 | Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials | ||||
| ISO 10993-11:2006 | Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity | ||||
| ISO 10993-14:2001 | Biological evaluation of medical devices -- Part 14: Identification and quantification of degradation products from ceramics | ||||
| ISO 10993-12:2002 | Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials | ||||
| ISO 10993-10:2002 | Biological evaluation of medical devices -- Part 10: Tests for irritation and delayed-type hypersensitivity | ||||
| ISO 10993-12:2012 | Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials | ||||
| ISO/IEC 14496-3:2009/Amd 6:2017 | Profiles, levels and downmixing method for 22.2 channel programs | ||||
| ISO 10993-17:2002 | Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances | ||||
| ISO 10993-18:2005 | Biological evaluation of medical devices -- Part 18: Chemical characterization of materials | ||||
| ISO 10993-15:2000 | Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys | ||||
| ISO/CD 10993-15 | Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys | ||||
| ISO 10993-16:2010 | Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables | ||||
| ISO/CD 10993-18 | 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 14155-1:2003 | Clinical investigation of medical devices for human subjects -- Part 1: General requirements | ||||
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects -- Part 2: Clinical investigation plans | ||||
| ISO/TR 15499:2016 | Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process | ||||
| ISO/AWI 18115-1 | Surface chemical analysis -- Vocabulary -- Part 1: General terms and terms used in spectroscopy | ||||
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects -- Good clinical practice | ||||
| ISO 17593:2007 | Clinical laboratory testing and in vitro medical devices -- Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy | ||||
| ISO/TR 11548-2:2001 | Communication aids for blind persons -- Identifiers, names and assignation to coded character sets for 8-dot Braille characters -- Part 2: Latin alphabet based character sets | ||||
| ISO/TR 14032:1999 | Environmental management -- Examples of environmental performance evaluation (EPE) | ||||
| ISO/DIS 14064-1 | Greenhouse gases -- Part 1: Specification with guidance at the organization level for quantification and reporting of greenhouse gas emissions and removals | ||||
| ISO/CD 14064-3 | Greenhouse gases -- Part 3: Specification with guidance for the validation and verification of greenhouse gas assertions | ||||
| ISO 7168-2:1999 | Air quality -- Exchange of data -- Part 2: Condensed data format | ||||
| ISO 7708:1995 | Air quality -- Particle size fraction definitions for health-related sampling | ||||
| ISO 9169:2006 | Air quality -- Definition and determination of performance characteristics of an automatic measuring system | ||||
| ISO 11771:2010 | Air quality -- Determination of time-averaged mass emissions and emission factors -- General approach | ||||
| ISO 14956:2002 | Air quality -- Evaluation of the suitability of a measurement procedure by comparison with a required measurement uncertainty | ||||
| ISO 3724:2007 | Hydraulic fluid power -- Filter elements -- Determination of resistance to flow fatigue using particulate contaminant | ||||
| ISO 10156-2:2005 | Gas cylinders -- Gases and gas mixtures -- Part 2: Determination of oxidizing ability of toxic and corrosive gases and gas mixtures | ||||
| ISO 14644-5:2004 | Cleanrooms and associated controlled environments -- Part 5: Operations | ||||
| ISO 14644-6:2007 | Cleanrooms and associated controlled environments -- Part 6: Vocabulary | ||||
| ISO 14644-7:2004 | Cleanrooms and associated controlled environments -- Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) | ||||
| ISO 14644-8:2013 | Cleanrooms and associated controlled environments -- Part 8: Classification of air cleanliness by chemical concentration (ACC) | ||||
| ISO 14644-9:2012 | Cleanrooms and associated controlled environments -- Part 9: Classification of surface cleanliness by particle concentration | ||||
| ISO 14644-8:2006 | Cleanrooms and associated controlled environments -- Part 8: Classification of airborne molecular contamination | ||||
| ISO 14644-14:2016 | Cleanrooms and associated controlled environments -- Part 14: Assessment of suitability for use of equipment by airborne particle concentration | ||||
| ISO 14698-1:2003 | Cleanrooms and associated controlled environments -- Biocontamination control -- Part 1: General principles and methods | ||||
| ISO 7935:1992 | Stationary source emissions -- Determination of the mass concentration of sulfur dioxide -- Performance characteristics of automated measuring methods | ||||
| ISO 14698-2:2003 | Cleanrooms and associated controlled environments -- Biocontamination control -- Part 2: Evaluation and interpretation of biocontamination data | ||||
| ISO 9096:2003 | Stationary source emissions -- Manual determination of mass concentration of particulate matter | ||||
| ISO 10155:1995 | Stationary source emissions -- Automated monitoring of mass concentrations of particles -- Performance characteristics, test methods and specifications | ||||
| ISO 10397:1993 | Stationary source emissions -- Determination of asbestos plant emissions -- Method by fibre count measurement | ||||
| ISO 10396:2007 | Stationary source emissions -- Sampling for the automated determination of gas emission concentrations for permanently-installed monitoring systems | ||||
| ISO 8288:1986 | Water quality -- Determination of cobalt, nickel, copper, zinc, cadmium and lead -- Flame atomic absorption spectrometric methods |
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