🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
BS EN ISO 17664-1:2021

BS EN ISO 17664-1:2021

$167.15

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 36
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

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
2 National foreword
6 European foreword
8 Annex ZA (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
10 Foreword
11 Introduction
13 1 Scope
14 2 Normative references
3 Terms and definitions
17 4 Validation of the processes identified in the information provided by the medical device manufacturer
5 Risk analysis
18 6 Information to be provided by the medical device manufacturer
6.1 General
6.2 Processing instructions
19 6.3 Limitations and restrictions on processing
6.4 Initial treatment at the point of use
6.5 Preparation before cleaning
20 6.6 Cleaning
6.6.1 General
6.6.2 Automated cleaning
6.6.3 Manual cleaning
21 6.7 Disinfection
6.7.1 General
6.7.2 Automated disinfection
22 6.7.3 Manual disinfection
6.8 Drying
6.9 Inspection and maintenance
23 6.10 Packaging
6.11 Sterilization
24 6.12 Storage
6.13 Transportation
7 Presentation of the information
25 Annex A (informative) Commonly utilized processing methods
29 Annex B (informative) Example of processing instructions for reusable medical devices
31 Annex C (informative) Classification of medical devices
34 Annex D (informative) Additional guidance on information to be provided by the medical device manufacturer
35 Bibliography

Related products

BS EN ISO 17664-1:2021
$167.15