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BS ISO 17664-2:2021

BS ISO 17664-2:2021

$167.15

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

Published By Publication Date Number of Pages
BSI 2021 36
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This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact).

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. preparation before processing;

  2. cleaning;

  3. disinfection;

  4. drying;

  5. inspection and maintenance;

  6. packaging;

  7. storage;

  8. transportation.

This document excludes processing of:

  1. critical and semi-critical medical devices;

  2. medical devices intended to be sterilized;

  3. textile medical devices used in patient draping systems or surgical clothing;

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

NOTE

See Annex E for further guidance on the application of the ISO 17664 series to a medical device.

PDF Catalog

PDF Pages PDF Title
2 National foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
12 4 Risk analysis
13 5 Validation of the processes identified in the information provided by the medical device manufacturer
6 Information to be provided by the medical device manufacturer
6.1 General
14 6.2 Processing instructions
15 6.3 Limitations and restrictions on processing
6.4 Preparation before processing
6.5 Cleaning
6.5.1 General
6.5.2 Manual cleaning
16 6.5.3 Automated cleaning
6.6 Disinfection
6.6.1 General
6.6.2 Manual disinfection
17 6.6.3 Automated disinfection
6.7 Drying
18 6.8 Inspection and maintenance
6.9 Packaging
6.10 Storage
6.11 Transportation
7 Presentation of the information
19 Annex A (informative) Commonly utilized processing methods
26 Annex B (informative) Example processing instructions for non-critical reusable medical devices
28 Annex C (informative) Processing classification and grouping of medical devices
30 Annex D (informative) Additional guidance on information to be provided by the medical device manufacturer
31 Annex E (informative) Examples of medical devices and their relationship to this document
35 Bibliography

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BS ISO 17664-2:2021
$167.15