I.S. EN ISO 17664:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017)
Hardcopy , PDF
English
01-01-2017
25-09-2021
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.
National foreword
European foreword
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 devices
Annex D (informative) - Additional guidance on information
to be provided by the medical device manufacturer
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements
of EU Directive 93/42/EEC on medical devices
Defines requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use.
| DocumentType |
Greenline
|
| Pages |
42
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NBN EN ISO 17664 : 2004 | Identical |
| BS EN ISO 17664:2004 | Identical |
| DIN EN ISO 17664:2016-06 (Draft) | Identical |
| ISO 17664:2017 | Identical |
| EN ISO 17664:2017 | Identical |
| BS EN ISO 17664:2017 | Equivalent |
| ISO 17664:2017 | Equivalent |
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