biological evaluation

biological evaluation, Total:72 items.

The international standard classification for "biological evaluation" includes: Medical equipment in general , Dental materials , Surgical instruments and materials , Ophthalmic equipment , Laboratory medicine , Medical microbiology , Medical equipment .

The Chinese standard classification for "biological evaluation" includes: Medical apparatus and devices in general , Stomatologic device, equipment and material , Medical optical instrument and endoscope , Medical sanitary products .

Professional Standard - Medicine

YY/T 0127.4-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method Bone implant test
YY/T 1512-2017 Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process
YY/T 0127.11-2014 Biological evaluation of medical devices used in dentistry―Part 11:Pulp capping test
YY/T 0127.13-2009 Biological evaluation of medical devices used in dentistry - Part 2: Test method - Oral mucous membrane irritation test
YY/T 0268-2008 Dentistry - Biological evaluation of medical devices used in dentistry Part1: Evaluation and test
YY/T 1295-2015 Biological evaluation of medical devices―Nanomaterial:Endotoxin test
YY/T 0127.5-2014 Biological evaluation of medical devices used in dentistry―Part 5:Inhalation toxicity test
YY/T 0127.4-1998 Biological evaluation of dental materials―Unit 2:Biological evaluation method of dental materials―Bone implant test
YY/T 0127.3-2014 Biological evaluation of medical devices used in dentistry―Part 3:Endodontic usage test
YY 0719.7-2011 Ophthalmic optics—Contact lens care products—Part 7:Biological evaluation test methods

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

GB/T 16886.9-2017 Biological evaluation of medical devices―Part 9:Framework for identification and quantification of potential degradation products
GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1:Evaluation and testing
GB/T 16886.12-2005 Biological evaluation of medical devices-Part 12:Sample preparation and reference materials
GB/T 16886.9-2022 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products
GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization
GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials
GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys
GB/T 16886.2-2000 Biological evaluation of medical devices--Part 2:Animal welfare requirements
GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity
GB/T 16886.16-2013 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables
GB/T 16886.9-2001 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
GB/T 16886.19-2011 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials
GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.3-2008 Biological evaluation of medical devices - Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicity
GB/T 16886.5-2017 Biological evaluation of medical devices―Part 5:Tests for in vitro cytotoxicity
GB/T 16175-1996 Organic silicon material for medical use-Biological evaluation test methods
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
GB/T 16886.18-2011 Biological evaluation of medical devices—Part 18:Chemical characterization of materials
GB/T 16886.6-1997 Biological evaluation of medical devices--Part 6:Tests for local effects after implantation
GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials
GB/T 16886.23-2023 Biological evaluation of medical devices—Part 23: Tests for irritation
GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.16-2021 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
GB/T 16886.17-2005 Biological evaluation of medical devices - Part 17 : Estabilishment of allowable limits for leachable substances
GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.10-2000 Biological evaluation of medical devices-Part 10:Tests for irritation and sensitization
GB/T 16886.15-2003 Biological eveluation of medical devices--Part 15:Inentificatoin and quantificatoin of degradation products from metals and alloys
GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.7-2001 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
GB/T 16886.11-1997 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity
GB/T 16886.4-2003 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
GB/T 16886.6-2015 Biological evaluation of medical devices―Part 6:Tests for local effects after implantation
GB/T 16886.10-2005 Biological evaluation of medical devices-Part 10:Tests for irritation and delayed-type hypersensitivity
GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements
GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials
GB/T 16175-2008 Biological evaluation test methods for medical organic silicon materials
GB/T 16886.14-2003 Biological evaluation of medical devices--Part 14:Identification and quantificaton of degradation products from ceramics

Group Standards of the People's Republic of China

T/CAMDI 034-2020 Biological evaluation of medical devices Medical catheter with hydrophilic polymer coating：Sample preparation
T/CAMDI 033-2020 Guide for biological evaluation of packaging materials for medical devices

German Institute for Standardization

DIN EN ISO 10993-18:2009 Biological assessment of medical devices

Bureau of Indian Standards

IS/ISO/TR 15499-2016 Biological Evaluation of Medical Devices â€” Guidance on the Conduct of Biological Evaluation within a Risk Management Process

International Organization for Standardization (ISO)

ISO/CD 10993-1.2:2023 Biological evaluation of medical devices
ISO/TR 15499:2016 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
ISO/TR 7405:1984 Biological evaluation of dental materials
ISO/TR 15499:2012 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process

GCC Standardization Organization

GSO ISO/TR 15499:2016 Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process

The Directorate General of Specifications and Metrology (DGSM)

OS GSO ISO/TR 15499:2016 Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process

Danish Standards Foundation

DANSK DS/ISO/TR 15499:2016 Biological evaluation of medical devices – Guidance on the conduct of biological evaluation within a risk management process

SCC

AAMI/ISO TIR15499:2012 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process

US-AAMI

ANSI/AAMI/ISO TIR15499:2012 Biological evaluation of medical devices - Guideance on the conduct of biological evaluation within a risk management process

Standards Norway

SN-ISO/TR 15499:2012 Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process

Korean Agency for Technology and Standards (KATS)

KS P ISO TR 15499-2021 Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process

Ente Nazionale Italiano di Unificazione

UNI EN ISO 10993-1:1999 Biological evaluation of medical devices - Evaluation and testing

British Standards Institution (BSI)

BS EN ISO 10993-1:1998 Biological evaluation of medical devices-Evaluation and testing
BS PD ISO/TR 15499:2016 Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
BS 5828:1980 Methods of biological assessment of dental materials
BS 5828:1989 Methods for biological assessment of dental materials

Association Francaise de Normalisation

NF S99-501:1998 Biological evaluation of medical devices. Part 1 : evaluation and testing.