UNE-EN ISO 22442-1:2016
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
Available format(s)
Hardcopy , PDF
Language(s)
Spanish, Castilian, English
Published date
27-04-2016
Publisher
Superseded date
19-01-2022
€100.80
Excluding VAT
| Committee |
CTN 111
|
| DevelopmentNote |
Supersedes UNE EN 12442-1. (06/2008)
|
| DocumentType |
Standard
|
| Pages |
40
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Superseded
|
| Standards | Relationship |
| EN ISO 22442-1:2015 | Identical |
| ISO 22442-1:2015 | Identical |
| ISO 13408-4:2005 | Aseptic processing of health care products — Part 4: Clean-in-place technologies |
| ISO 13408-7:2012 | Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products |
| 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 |
| ISO 14160:2011 | Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| ISO 13408-2:2003 | Aseptic processing of health care products — Part 2: Filtration |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO 14937:2009 | Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 10993-14:2001 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
| ISO 13408-3:2006 | Aseptic processing of health care products — Part 3: Lyophilization |
| 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 |
| ISO 10993-10:2010 | Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| ISO 10993-12:2012 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials |
| ISO 10993-7:2008 | Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling |
| ISO 10993-9:2009 | Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 13408-6:2005 | Aseptic processing of health care products — Part 6: Isolator systems |
| ISO 17664:2017 | Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices |
| ISO 10993-6:2016 | Biological evaluation of medical devices — Part 6: Tests for local effects after implantation |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 13408-5:2006 | Aseptic processing of health care products — Part 5: Sterilization in place |
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