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BS EN ISO 17664-1:2021 – TC

BS EN ISO 17664-1:2021 – TC

$217.84

Tracked Changes. Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices – Critical and semi-critical medical devices

Published By Publication Date Number of Pages
BSI 2021 82
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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.

This includes information for processing prior to use or reuse of the medical device.

Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable:

  1. initial treatment at the point of use;

  2. preparation before cleaning;

  3. cleaning;

  4. disinfection;

  5. drying;

  6. inspection and maintenance;

  7. packaging;

  8. sterilization;

  9. storage;

  10. transportation.

This document excludes processing of the following:

  • non-critical medical devices unless they are intended to be sterilized;

  • textile devices used in patient draping systems or surgical clothing;

  • medical devices specified by the manufacturer for single use only and supplied ready for use.

NOTE

See ISO 17664-2:2021, Annex E, for further guidance on the application of the ISO 17664 series to a medical device.

PDF Catalog

PDF Pages PDF Title
48 National foreword
52 European foreword
54 Annex ZA (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
56 Foreword
57 Introduction
59 1 Scope
60 2 Normative references
3 Terms and definitions
63 4 Validation of the processes identified in the information provided by the medical device manufacturer
5 Risk analysis
64 6 Information to be provided by the medical device manufacturer
6.1 General
6.2 Processing instructions
65 6.3 Limitations and restrictions on processing
6.4 Initial treatment at the point of use
6.5 Preparation before cleaning
66 6.6 Cleaning
6.6.1 General
6.6.2 Automated cleaning
6.6.3 Manual cleaning
67 6.7 Disinfection
6.7.1 General
6.7.2 Automated disinfection
68 6.7.3 Manual disinfection
6.8 Drying
6.9 Inspection and maintenance
69 6.10 Packaging
6.11 Sterilization
70 6.12 Storage
6.13 Transportation
7 Presentation of the information
71 Annex A (informative) Commonly utilized processing methods
75 Annex B (informative) Example of processing instructions for reusable medical devices
77 Annex C (informative) Classification of medical devices
80 Annex D (informative) Additional guidance on information to be provided by the medical device manufacturer
81 Bibliography

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BS EN ISO 17664-1:2021 - TC
$217.84