ISO 17664-2:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices —Part 2: Non-critical medical devices

标准简介

Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices —Part 2: Non-critical medical devices由ISO于2021-02-25发布，适用于世界范围。

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INTERNATIONAL STANDARD ISO 17664-2:2021

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

Part 2: Non-critical medical devices

1 Scope

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:

a) preparation before processing;

b) cleaning;

c) disinfection;

d) drying;

e) inspection and maintenance;

f) packaging;

g) storage;

h) 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.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 14971, Medical devices — Application of risk management to medical devices

ISO 17664-2:2021

3 Terms a nd definiti ons

For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https://www.iso.org/obp

— IEC Electropedia: available at http://www.electropedia.org/

3.1

cleaning

removal of contaminants to the extent necessary for further processing or for intended use

Note 1 to entry: Cleaning consists of the removal of adherent soil (e.g. blood, protein substances and other debris) from the surfaces, crevices, serrations, joints and lumens of a medical device by a manual or automated process that prepares the items for safe handling and/or further processing.

[SOURCE: ISO 11139:2018, 3.46, modified — Note 1 to entry has been added.]

3.2

cleaning agent

physical or chemical entity, or combination of entities, having activity to render an item clean

[SOURCE: ISO 11139:2018, 3.47]

3.3

clinical use

use of a health care product during a procedure on a patient

[SOURCE: ISO 11139:2018, 3.49]

3.4

disinfecting agent

physical or chemical agent used for disinfection

[SOURCE: ISO 11139:2018, 3.83]

3.5

disinfection

process to inactivate viable microorganisms to a level previously specified as being appropriate for a defined purpose

[SOURCE: ISO 11139:2018, 3.84]

3.6

manual cleaning

removal of contaminants from an item to the extent necessary for further processing or for intended use without the use of an automated process

[SOURCE: ISO 11139:2018, 3.159]

3.7

medical device

instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific medical purpose(s) of:

— diagnosis, prevention, monitoring, treatment or alleviation of disease;

— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;

— investigation, replacement, modification or support of the anatomy or of a physiological process;

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