DIN EN ISO 10993-1:2010-04
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
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Superseded date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
Superseded by
Language(s)
English, German
Published date
01-04-2010
Important note : All end users must be registered with an Account prior to user licenses being assigned.| DevelopmentNote |
Supersedes DIN EN 30993-1. (05/2002) DRAFT 2017 issued in April 2017. (04/2017)
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| DocumentType |
Standard
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| Pages |
31
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| ProductNote |
Supersedes DIN EN 30993-1. (SHM 05/2002) DRAFT 2017 issued in April 2017; price: 148.60 Euro. (Sukh 04/2017)
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| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
| 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 |
| 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) |
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