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I.S. EN ISO 17664-1:2021

Current

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)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

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.

€42.00
Excluding VAT

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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