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ISO 17664:2017

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

General information

Withdrawn from 06.07.2021
ICS Groups
11.080.01 Sterilization and disinfection in general
Directives or regulations
None

Standard history

Status
Date
Type
Name
06.07.2021
Main
ISO 17664-1:2021
25.10.2017
Main
ISO 17664:2017
Main
ISO 17664:2004
ISO 17664:2017 specifies 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.
This includes information for processing prior to use or reuse of the medical device. The provisions of ISO 17664:2017 are applicable to medical devices that are intended for invasive or other direct or indirect patient contact.

Required fields are indicated with *

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PDF
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Paper
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Standard monitoring
English (PDF 682 KB)

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Amendment

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English