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BS EN ISO 17664:2017

Superseded

Superseded

View Superseded by

Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-08-2018

Superseded date

09-01-2021

Superseded by

BS EN ISO 17664-1:2021

US$391.00
Excluding Tax where applicable
Summarise this standard

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

Describes 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.

Committee
CH/198
DevelopmentNote
Supersedes 01/561624 DC. (04/2011) Supersedes 16/30280931 DC. (01/2018)
DocumentType
Standard
Pages
34
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
DIN EN ISO 17664:2016-06 (Draft) Identical
ISO 17664:2017 Identical
EN ISO 17664:2017 Identical
NBN EN ISO 17664 : 2004 Identical
I.S. EN ISO 17664:2004 Identical
I.S. EN ISO 17664:2017 Equivalent

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A newer version of this standard is available.

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US$391.00
Excluding Tax where applicable