I.S. EN 556-1:2024
Current
The latest, up-to-date edition.
Sterilization of medical devices - Requirements for medical devices to be designated \"STERILE\" - Part 1: Requirements for terminally sterilized medical devices
Hardcopy , PDF
English
04-07-2024
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.
Dates of withdrawal of national standards are available from NSAI.
European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
Annex ZB (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered
Bibliography
This document specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’. Part 2 of EN 566 specifies the requirements for an aseptically processed medical device to be designated “STERILE”.
| Committee |
CEN/TC 204
|
| DocumentType |
Standard
|
| Pages |
10
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN 556-1:2024-09 | Equivalent |
| BS EN 556-1:2024 | Equivalent |
| EN 556-1:2024 | Identical |
| EN 556-1:2001 | Identical |
| EN ISO 14971:2009 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| EN 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 14937:2009) |
| EN ISO 13004:2023 | Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022) |
| EN ISO 17664-1:2021 | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021) |
| EN ISO 15223-1:2016 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03) |
| EN ISO 11139:2018 | Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018) |
| ISO 17664-1:2021 | Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices |
| EN ISO 14160:2021 | 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 14160:2020) |
| ISO 11139:2018 | Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards |
| EN ISO 11137-3:2017 | Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017) |
| EN ISO 11737-1:2018 | Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018) |
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