I.S. EN ISO 22442-1:2020
Current
The latest, up-to-date edition.
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
Hardcopy , PDF
English
28-12-2020
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Risk management process
Annex A (informative) Guidance on the application of this document
Annex B (informative) Graphical representation of part of the risk management process for medical devices utilizing animal material
Annex C (normative) Special requirements for some animal materials considering the risk management for TSE agents
Annex D (informative) Information relevant to the management of TSE risk
Bibliography
This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable.
| Committee |
ISO/TC 194
|
| DocumentType |
Standard
|
| Pages |
46
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 22442-1:2020 | Identical |
| EN ISO 22442-1:2020 | Identical |
| ISO 10993-15:2019 | Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys |
| 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 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| 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 11135-1:2007 | Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO/TS 10993-19:2020 | Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials |
| ISO 11737-3:2004 | Sterilization of medical devices — Microbiological methods — Part 3: Guidance on evaluation and interpretation of bioburden data |
| ISO 10993-10:2010 | Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization |
| ISO 14160:2020 | 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 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 11137-3:2017 | Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| 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 10993-18:2020 | Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process |
| 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 |
| ISO 13408-2:2018 | Aseptic processing of health care products — Part 2: Sterilizing filtration |
| ISO 10993-9:2019 | Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products |
Access your standards online with a subscription
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.
Important note : All end users must be registered with an Account prior to user licenses being assigned.