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DIN EN ISO 10993-6:2009-08
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)
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ISO/IEC 17025:2005
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General requirements for the competence of testing and calibration laboratories
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ISO 10993-3:2014
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Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
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|
ISO 10993-4:2017
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Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
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|
ISO 10993-16:2017
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Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
|
|
ISO/TS 10993-20:2006
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Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
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|
DIN EN ISO 10993-2:2006-10
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Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
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|
DIN EN ISO 10993-7:2009-02
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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
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|
ISO 10993-13:2010
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Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
|
|
DIN EN ISO 10993-11:2015-12 (Draft)
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
|
|
ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes
|
|
DIN EN ISO 14971:2013-04
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
|
|
ISO 10993-2:2006
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Biological evaluation of medical devices — Part 2: Animal welfare requirements
|
|
ISO 7405:2008
|
Dentistry Evaluation of biocompatibility of medical devices used in dentistry
|
|
ISO 10993-14:2001
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Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
|
|
DIN EN ISO 10993-15:2009-10
|
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
|
|
DIN EN ISO 10993-16:2016-04 (Draft)
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES (ISO 10993-16:2017)
|
|
ISO 10993-18:2005
|
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
|
|
DIN EN ISO 10993-5:2009-10
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
|
|
ISO 10993-10:2010
|
Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
|
|
ISO 9004:2009
|
Managing for the sustained success of an organization A quality management approach
|
|
ISO 10993-11:2017
|
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
|
|
DIN EN ISO 10993-12:2012-10
|
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
|
|
ISO 10993-12:2012
|
Biological evaluation of medical devices Part 12: Sample preparation and reference materials
|
|
DIN EN ISO 10993-4:2016-02 (Draft)
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD (ISO 10993-4:2017)
|
|
ISO 10993-7:2008
|
Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
|
|
DIN EN ISO 10993-18:2009-08
|
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2009
|
|
ISO 10993-17:2002
|
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
|
|
ISO 9001:2015
|
Quality management systems — Requirements
|
|
DIN EN ISO 10993-10:2014-10
|
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
|
|
ISO 10993-9:2009
|
Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
|
|
ISO 9000:2015
|
Quality management systems — Fundamentals and vocabulary
|
|
ISO 14971:2007
|
Medical devices Application of risk management to medical devices
|
|
DIN EN ISO 10993-17:2009-08
|
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
|
|
DIN EN ISO 10993-14:2009-08
|
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
|
|
ISO 10993-6:2016
|
Biological evaluation of medical devices Part 6: Tests for local effects after implantation
|
|
DIN EN ISO 10993-9:2010-04
|
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
|
|
DIN EN ISO 10993-3:2015-02
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY (ISO 10993-3:2014)
|
|
DIN EN ISO 10993-13:2010-11
|
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
|
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