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ÖNORM EN ISO 10993-1:2011-03

Заменен
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009 + Cor 1:2010) (consolidated version)
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 10993-2:2006
Действует
Biological evaluation of medical devices -- Part 2: Animal welfare requirements — 20 стр.
ISO 10993-3:2014
Действует
Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity — 42 стр.
ISO 10993-4:2002/Amd.1:2006
Заменен
Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood -- Amendment 1 — 10 стр.
ISO 10993-5:2009
Действует
Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity — 42 стр.
ISO 10993-6:2007
Заменен
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation — 28 стр.
ISO 10993-7:2008/Cor.1:2009
Действует
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals -- Technical Corrigendum 1 — 2 стр.
ISO 10993-9:2009
Действует
Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products — 16 стр.
ISO 10993-10:2010
Действует
Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization — 74 стр.
ISO 10993-11:2017
Действует
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity — 36 стр.
ISO 10993-12:2012
Действует
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials — 28 стр.
ISO 10993-13:2010
Действует
Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices — 22 стр.
ISO 10993-14:2001
Действует
Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics — 18 стр.
ISO 10993-15:2000
Действует
Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys — 20 стр.
ISO 10993-16:2010
Заменен
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables — 18 стр.
ISO 10993-17:2002
Действует
Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances — 31 стр.
ISO 10993-18:2005
Действует
Biological evaluation of medical devices -- Part 18: Chemical characterization of materials — 24 стр.
ISO/TS 10993-19:2006
Действует
Biological evaluation of medical devices -- Part 19: Physicochemical, morphological and topographical characterization of materials — 22 стр.
ISO/TS 10993-20:2006
Действует
Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices — 24 стр.
ISO 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
ÖNORM EN ISO 10993-1:2021-04
Действует
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
ÖNORM EN ISO 10993-1:2010-03
Заменен
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

На этот документ ссылаются

ÖNORM EN ISO 7439:2010-11
Отменен
Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO 7439:2002)
ÖNORM EN 1642:2010-03
Заменен
Dentistry - Medical devices for dentistry - Dental implants
ÖNORM EN 12182:1999-12
Заменен
Technical aids for disabled persons - General requirements and test methods
DIN EN 15424:2007-08
Отменен
Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices; German version EN 15424:2007 — 51 стр.
DIN EN ISO 1135-4:2010-09
Отменен
Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010); German version EN ISO 1135-4:2010 — 25 стр.
DIN EN ISO 24234:2005-01
Отменен
Dentistry - Mercury and alloys for dental amalgam (ISO 24234:2004); German version EN ISO 24234:2004 — 38 стр.
DIN EN ISO 81060-1:2012-08
Действует
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007); German version EN ISO 81060-1:2012 — 50 стр.
DIN EN 1642:2010-02
Отменен
Dentistry - Medical devices for dentistry - Dental implants; German version EN 1642:2009 — 13 стр.
DIN EN 1642:2012-06
Действует
Dentistry - Medical devices for dentistry - Dental implants; German version EN 1642:2011 — 13 стр.
DIN EN 12182:2012-07
Действует
Assistive products for persons with disability - General requirements and test methods; German version EN 12182:2012 — 66 стр.
DIN EN 13674-1:2008-01
Отменен
Railway applications - Track - Rail - Part 1: Vignole railway rails 46 kg/m and above; German version EN 13674-1:2003+A1:2007 — 108 стр.
DIN EN 13824:2005-02
Отменен
Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements; German version EN 13824:2004 — 64 стр.
DIN EN ISO 7439:2002-10
Отменен
Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO 7439:2002); German version EN ISO 7439:2002 — 15 стр.
DIN EN ISO 7439:2010-12
Отменен
Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO 7439:2002); German version EN ISO 7439:2009 — 20 стр.
DIN EN ISO 7439:2011-04
Отменен
Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO/FDIS 7439:2011); German version FprEN ISO:2011 — 22 стр.
DIN EN ISO 7439:2010-10
Отменен
Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO/FDIS 7439:2010); German version FprEN ISO 7439:2010 — 20 стр.
DIN EN ISO 3107:2005-01
Отменен
Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements (ISO 3107:2004); German version EN ISO 3107:2004 — 20 стр.
DIN EN ISO 3107:2011-06
Действует
Dentistry - Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements (ISO 3107:2011); German version EN ISO 3107:2011 — 16 стр.
DIN EN ISO 10993-13:2009-08
Отменен
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998); German version EN ISO 10993-13:2009 — 24 стр.
DIN EN ISO 10993-7:2009-02
Действует
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); German version EN ISO 10993-7:2008 — 108 стр.
DIN EN ISO 10993-13:2010-11
Действует
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010 — 26 стр.
DIN EN ISO 10451:2002-07
Отменен
Dental implant systems - Contents of technical file (ISO 10451:2002); German version EN ISO 10451:2002 — 12 стр.
DIN EN ISO 10451:2010-11
Действует
Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010); German version EN ISO 10451:2010 — 15 стр.
DIN EN ISO 10993-10:2009-08
Отменен
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006); German version EN ISO 10993-10:2009 — 68 стр.
DIN EN ISO 8536-4:2007-06
Отменен
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2007); German version EN ISO 8536-4:2007 — 23 стр.
DIN EN ISO 11979-5:2006-09
Отменен
Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006); German version EN ISO 11979-5:2006 — 32 стр.
DIN EN ISO 11979-8:2009-08
Отменен
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006); German version EN ISO 11979-8:2009 — 12 стр.
DIN EN ISO 14155-1:2009-11
Отменен
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003); German version EN ISO 14155-1:2009 — 32 стр.
DIN EN ISO 14534:2009-07
Отменен
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002); German version EN ISO 14534:2009 — 20 стр.
DIN EN ISO 14155-2:2009-11
Отменен
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); German version EN ISO 14155-2:2009 — 17 стр.
DIN EN ISO 15747:2010-08
Отменен
Plastic containers for intravenous injections (ISO 15747:2010); German version EN ISO 15747:2010 — 22 стр.
DIN EN ISO 14534:2009-09
Отменен
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO/DIS 14534:2009); German version prEN ISO 14534:2009 — 20 стр.
DIN EN ISO 20126:2012-06
Отменен
Dentistry - Manual toothbrushes - General requirements and test methods (ISO 20126:2012); German version EN ISO 20126:2012 — 16 стр.
ÖNORM EN ISO 10993-1:2010-03
Заменен
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
ÖNORM EN 455-3:2007-03
Заменен
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
ÖNORM EN 12523:1999-06
Действует
External limb prostheses and external orthoses - Requirements and test methods
ÖNORM EN 14683:2014-05
Заменен
Medical face masks - Requirements and test methods
ÖNORM EN ISO 10993-1:2021-04
Действует
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)