DIN EN ISO 10993-1:2010-04

Superseded

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009)

Available format(s)

Hardcopy , PDF

Superseded date

29-04-2021

Language(s)

English, German

Published date

01-04-2010

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

DevelopmentNote	Supersedes DIN EN 30993-1. (05/2002) DRAFT 2017 issued in April 2017. (04/2017)
DocumentType	Standard
Pages	31
ProductNote	Supersedes DIN EN 30993-1. (SHM 05/2002) DRAFT 2017 issued in April 2017; price: 148.60 Euro. (Sukh 04/2017)
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Superseded
SupersededBy	DIN EN ISO 10993-1:2021-05
Supersedes	DIN EN ISO 10993-1:2009-10

Standards	Relationship
NF EN ISO 10993-1 : 2010	Identical
SN EN ISO 10993-1 : 2010 CORR 2010	Identical
BS EN ISO 10993-1 : 2009-10	Identical
NEN EN ISO 10993-1 : 2009 C1 2010	Identical
I.S. EN ISO 10993-1:2009+AC:2010	Identical
ISO 10993-1:2009	Identical
NBN EN ISO 10993-1 : 2009 COR 2010	Identical
UNE-EN ISO 10993-1:2010	Identical
NS EN ISO 10993-1 : 2009 COR 2010	Identical
EN ISO 10993-1:2009/AC:2010	Identical
UNI EN ISO 10993-1 : 2010	Identical
ONORM EN ISO 10993-1 : 2011	Identical

DIN EN ISO 10993-6:2009-08	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)
ISO/IEC 17025:2005	General requirements for the competence of testing and calibration laboratories
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 10993-16:2017	Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
ISO/TS 10993-20:2006	Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
DIN EN ISO 10993-2:2006-10	Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
DIN EN ISO 10993-7:2009-02	Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
ISO 10993-13:2010	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)	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
DIN EN ISO 14971:2013-04	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
ISO 10993-2:2006	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	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)