I.S. EN ISO 17664-1:2021
Current
The latest, up-to-date edition.
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semicritical medical devices (ISO 17664-1:2021)
Hardcopy , PDF
English
19-09-2021
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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Validation of the processes identified in the information provided by the medical
device manufacturer
5 Risk analysis
6 Information to be provided by the medical device manufacturer
7 Presentation of the information
Annex A (informative) Commonly utilized processing methods
Annex B (informative) Example of processing instructions for reusable medical devices
Annex C (informative) Classification of medical device
Annex D (informative) Additional guidance on information to be provided by the medical
device manufacturer
Bibliography
This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.
| Committee |
TC 198
|
| DocumentType |
Standard
|
| Pages |
42
|
| ProductNote |
This standard is also refer to AAMI/TIR 30 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 17664-1:2021 | Identical |
| BS EN ISO 17664-1:2021 | Identical |
| EN ISO 17664-1:2021 | Identical |
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